Clinical Study Synopsis -...

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Clinical Trial Results Synopsis 02-Feb-2017 Study no. 16216 Page: 1 of 10

Date of study report: 20 OCT 2016

Study title: Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients with Bone Metastasis

Sponsor’s study number:

16216

NCT number: NCT01618370

EudraCT number: 2012-000075-16

Sponsor: Bayer

Clinical phase: IIIb

Study objectives: To assess the acute and long-term safety of Radium RA 223 dichloride (Ra-223) dichloride

To assess the Overall Survival of this subject population

Test drug: Radium-223 dichloride (Xofigo; BAY 88-8223)

Name of active ingredient(s):

Radium-223 dichloride

Dose: 50 kBq/kg body weight

Route of administration:

Intravenous

Duration of treatment: Every 4 weeks for up to 6 cycles

Reference drug: Not applicable

Indication: Castration resistant (CR) / hormone refractory (HR) prostate cancer with bone metastasis


Diagnosis and main criteria for

inclusion:

≥18 years with histologically or cytologically confirmed prostate cancer

Subjects diagnosed with progressive bone predominant metastatic CRPC/HRPC with at least two skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed). A standard of practice bone scan for the documentation of at least 2 skeletal metastases can be used as long as it is within 3 months of planned start of treatment. If no bone scan within a 3 month window is available, then a technetium-99m bone scan will be obtained at screening (within 28 days of planned start of study drug)

o Progressive was defined as the appearance of new bone lesions or 2 subsequent increases in serum PSA over the previous reference value

No intention to use cytotoxic chemotherapy within the next 6 months

Adequate hematological, liver, and renal function

Life expectancy ≥6 months

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Study design: International, prospective, interventional, open-label, multi-center study

Methodology: During the treatment period, study medication was administered every 4 weeks. Patients were evaluated at each visit, prior to receiving Ra-223 Cl2 for treatment-emergent Grade 3-4 AEs, all treatment-emergent AEs of any grade leading to drug discontinuation, all grades of treatment-related AEs, serious adverse events (SAEs), skeletal-related events (SREs), laboratory values, ECOG performance status, and for changes in bone pain (quality of life [QoL]) as measured by patient assessment using a validated questionnaire. The term skeletal-related event is used in this clinical study report (CSR) to mean the same as the newer term symptomatic skeletal event (SSE). During the follow-up period, patients were evaluated every 6 months for long-term safety including hematologic effects of Ra-223 Cl2 on peripheral blood counts, SREs, treatment-related AEs and SAEs, and occurrence of secondary malignancies. If the patient could no longer travel to the clinical site, he was followed up for survival, additional malignancies including acute myeloid leukemia (AML), hematological conditions such as myelodysplastic syndrome (MDS), aplastic anemia, myelofibrosis etc, and information on additional anti-cancer treatments received treatment with Ra-223 Cl2, seriousness, Common Terminology Criteria for Adverse Events (CTCAE) v4.03 grading, action taken,and outcome.


Study center(s): 115 study centers in 15 countries: Belgium (5 centers), Canada (5 centers), Germany (20 centers), Spain (19 centers), Finland (5 centers), Great Britain (8 centers), Ireland (3 centers), Israel (8 centers), Italy (13 centers), Netherlands (2 centers), Norway (5 centers), Poland (2 centers), Sweden (10 centers), Switzerland (8 centers), Russia (2 centers)

Publication(s) based on the study (references):

Saad F, Carles J, Gillessen S, Heidenreich A, Heinrich D, Gratt J, et al. Radium-223 and concomitant therapies in patients with metastatic castration-resistant prostate cancer: an international, early access, open-label, single-arm phase 3b trial. Lancet Oncol. 2016 17(9): 1306-16.

Study period: Study Start Date: 22 JUL 2012

Study Completion Date: 28 FEB 2016

Early termination: Not applicable

Number of subjects:

Planned: 1500

Analyzed: 708

Criteria for evaluation

Efficacy:

Overall survival, defined as the time in months from the start of therapy to death, due to any cause. Patients alive at the time of analysis were censored at the last date known to be alive.

Time to disease progression, defined as the time in months from the start of therapy to the date that disease progression was assessed per the local standard of care.


Safety:

ECOG performance status (PS) o Changes in PS from baseline on the ECOG scale to the PS

severity at each cycle, end of treatment, follow-up, and end of follow-up were tabulated by the number and percentage of patients in each shift change category.

o A patient was categorized as having a PS response or progression depending on whether there was an improvement or worsening, respectively, by 1 point or more on the ECOG scale from the baseline value.

Additional malignancies o Summary of additional primary malignancies was presented

by system organ class and preferred term. AML and MDS classifications were tabulated for each classification.

Adverse events o Adverse events of interest were those Common Terminology

Criteria for Adverse Events (CTCAE) Grade 3 to 5 treatment-related hematological and gastrointestinal AEs.

Clinical laboratory parameters


Statistical methods: All data were summarized descriptively.

Substantial protocol changes:

Protocol amendment 1 from 30 OCT 2012 introduced the following changes:

Changed Radium-223 Chloride and Ra223 Cl to Radium- 223 Dichloride and Ra-223 Cl2 respectively, following receipt of the official United States Adopted Name for the product

Clarification on the inclusion/exclusion criteria particularly the definition of progressive disease and acceptable diagnostic procedures

Inclusion of subjects with history of spinal cord compression who have completely recovered

Inclusion of allowed concomitant treatments, abiraterone and denosumab

Extension of the screening period from 21 days to 28 days and extension of the timeframe for laboratory assessments from 24 hours to within 72 hours

Addition of long-term follow-up section

Protocol amendment 2 from 02 APR 2013 introduced the following changes:

Exclusion from the active follow up of subjects who receive further anticancer treatment including radium 223 dichloride administered either within a clinical study or as commercially available drug, and to follow them up for survival status only.

Addition of a time window of 3 months for bone scan due to differences in the standard of care in the involved sites Provide clarifications and guidance on:

o Washout period of 4 weeks applicable for all prior anticancer therapies

o Anticancer therapies allowed during the study treatment period

o Guidance on when rescreening is allowed

o Definition of end of screening period

o Reconfirmation of eligibility


Substantial protocol changes

(continued):

Protocol amendment 3 from 24 JUN 2014, was locally valid only for centers located in Germany; it specified the following modification:

The German Radioprotection Agency, Bundesamt für Strahlenschutz (BfS), mandated that all German subjects enrolled in study 16216 have a long-term follow up of at least 5 years to collect data on long term effects of radium 223 dichloride. A separate, extended safety follow up protocol was set up.

Subject disposition and baseline

Overall, 852 subjects were enrolled in the study, and 708 of these subjects entered the Treatment Period and were administered at least one dose of radium-223 dichloride. The remaining 143 subjects were not treated and were discontinued at screening.

Efficacy The efficacy results at the end of study (Last patient last visit [LPLV] 28 FEB 2016) were consistent with those reported at primary completion (data cutoff date 21 NOV 2014; Report PH-38015). By the end of the study, 421 (59.5%) subjects had experienced disease progression. The median time to disease progression was 5.8 months. At primary completion (data cutoff date 21 NOV 2014; Report PH-38015), 410 (58.9%) subjects had experienced disease progression. The median time to disease progression was 6 months. By the end of the study, 224 (31.6%) subjects had died. The median overall survival (OS) was 16 months.

At primary completion (data cutoff date 21 NOV 2014; Report PH-38015), 210 (30.2%) subjects had died. The median OS was 16 months. .

At the end of study, total of 145 (20.5%) subjects experienced SREs during the study, of whom 107 (15.1%) received external beam radiotherapy for bone pain. The median time to SRE and median time to external beam radiotherapy could not be fully computed because of the small number of events recorded due to the short follow up.

At primary completion (data cutoff date 21 NOV 2014; Report PH-38015), 143 (20.5%) subjects experienced SREs of whom 105 (15.1%) received external beam radiotherapy for bone pain.

Safety evaluation All safety analyses were performed on the Safety population (708 subjects) which included all subjects who completed screening and received at least one dose of radium-223 dichloride by the end of study. Of the 708 subjects, half presented with a baseline ECOG PS of Grade 1 (49.9%), more than one third presented with a baseline ECOG PS Grade of 0 (37.4%). The remaining subjects presented with a baseline ECOG PS Grade of 2 (12.6%) and one subject had a baseline ECOG PS Grade of 4 (0.1%).


The overall safety profile for radium-223 dichloride-treated subjects at the end of the study

was consistent to that observed at the time of primary completion.

At the end of the study, the median duration of exposure to treatment with radium-223 dichloride was 20.1 weeks. The median number of injections of study treatment was 6 injections. The median actual dose of radium-223 dichloride during the study was 293.6 kBq/kg resulting from the sum of doses actually administered in kBq at each cycle of study treatment: (radioactivity in syringe before injection - radioactivity in syringe after injection) /body weight in kg.

At primary completion, the median duration of exposure to treatment with radium-223 dichloride was 20.1 weeks. The median number of injections of study treatment was 6 injections. The median actual dose of radium-223 dichloride during the study was 293.6 kBq/kg resulting from the sum of doses actually administered in kBq at each cycle of study treatment: (radioactivity in syringe before injection - radioactivity in syringe after injection) / body weight in kg.

At the end of the study, overall, 32.9% of subjects experienced ≥1 Grade 3 treatmentemergent adverse event (TEAE) and 4.5% experienced ≥1 Grade 4 TEAE during the Treatment Period. TEAEs by preferred term during the Treatment Period reported by 5% of subjects were: anemia (20.6% overall; 10.5% Grade 3; 0.0% Grade 4), bone pain (16.0% overall; 4.1% Grade 3; 0.0% Grade 4), nausea (12.9% overall; 0.3% Grade 3; 0.0% Grade 4), diarrhea (11.3% overall; 0.6% Grade 3; 0.0% Grade 4), fatigue (9.5% overall; 1.8% Grade 3; 0.0% Grade 4), decreased appetite (7.1% overall; 0.4% Grade 3; 0.0% Grade 4), back pain (7.2% overall; 2.8% Grade 3; 0.0% Grade 4), weight decreased (7.1% overall; 0.8% Grade 3; 0.0% Grade 4), and vomiting (5.9% overall; 1.1% Grade 3; 0.0% Grade 4). TEAEs considered by the investigator to be related to radium-223 dichloride were reported by 41.0% of subjects, the most common of which were anemia (10.0%), diarrhea (8.9%), and nausea (8.8%).

At primary completion, overall, 33.3% of subjects experienced ≥1 Grade 3 TEAE and 4.5% experienced ≥1 Grade 4 TEAE during the Treatment Period. TEAEs by preferred term during the Treatment Period reported 3; 0.0% Grade 4), bone pain (15.5% overall; 4.2% Grade 3; 0.0% Grade 4), nausea (13.1% overall; 0.3% Grade 3; 0.0% Grade 4), diarrhea (11.4% overall; 0.6% Grade 3; 0.0% Grade 4), fatigue (9.6% overall; 1.9% Grade 3; 0.0% Grade 4), decreased appetite (7.2% overall; 0.4% Grade 3; 0.0% Grade 4), back pain (7.2% overall; 2.9% Grade 3; 0.0% Grade 4), weight decreased (7.0% overall; 0.7% Grade 3; 0.0% Grade 4), and vomiting (6.0% overall; 1.1% Grade 3; 0.0% Grade 4). TEAEs considered by the investigator to be related to radium-223 dichloride were reported by 40.4% of subjects, the most common of which were anemia (9.3%), diarrhea (8.9%), and nausea (8.9%).

Treatment-related hematological AEs (in the SOCs “Blood and lymphatic system disorders” and “Investigations”) were: anemia in 71 subjects (10.0%), hemoglobin decreased in 3 subjects (0.4%), neutropenia in 9 subjects (1.3%), neutrophil count decreased in 8 subjects (1.1%), thrombocytopenia in 20 subjects (2.8%), and platelet count decreased in 21 subjects (3.0%).

At primary completion, hematological adverse events during the Treatment Period (events coded under the SOCs “Blood and lymphatic system disorders” and “Investigations”) included: anemia (20.1%), hemoglobin decreased (1.7%), neutropenia (1.9%), neutrophil count decreased (1.4%), thrombocytopenia (4.2%), and platelet count decreased (3.2%).

Treatment-related hematological AEs (in the SOCs “Blood and lymphatic system disorders” and “Investigations”) were: anemia in 65 subjects (9.3%), hemoglobin decreased in 3 subjects (0.4%),


neutropenia in 8 subjects (1.1%), neutrophil count decreased in 8 subjects (1.1%), thrombocytopenia in 20 subjects (2.9%), and platelet count decreased in 17 subjects (2.4%).

At the end of the study, TEAEs Grades 3 to 5 occurring in more than 10 subjects by preferred term were: anemia in 74 subjects (10.5%, all Grade 3), bone pain in 29 subjects (4.1%, all Grade 3), general physical health deterioration in 26 subjects (3.7% overall; 1.6% Grade 3; 0.4% Grade 4; 1.7% Grade 5), back pain in 20 subjects (2.8%, all Grade 3), spinal cord compression in 19 subjects (2.7% overall; 2.5% Grade 3; 0.1% Grade 4; 0.0% Grade 5), thrombocytopenia in 17 subjects (2.4% overall; 1.7% Grade 3; 0.7% Grade 4; 0.0% Grade 5), and fatigue in 13 subjects (1.8%, all Grade 3).

At primary completion, TEAEs Grades 3 to 5 occurring in more than 10 subjects by preferred term were: Bone pain in 29 subjects (4.2%, all Grade 3), general physical health deterioration in 26 subjects (3.7% overall; 1.6% Grade 3; 0.4% Grade 4; 1.7% Grade 5), back pain in 20 subjects (2.9%, all Grade 3), spinal cord compression in 19 subjects (2.7% overall; 2.6% Grade 3; 0.1% Grade 4; 0.0% Grade 5), thrombocytopenia in 17 subjects (2.4% overall; 1.7% Grade 3; 0.7% Grade 4; 0.0% Grade 5), and fatigue in 13 subjects (1.9%, all Grade 3).

At the end of the study, adverse events of interest reported by 5 or more subjects were: anemia in 30 subjects (4.2%), vomiting in 5 subjects (0.7%), thrombocytopenia in 11 subjects (1.6%), neutropenia in 6 subjects (0.8%), and neutrophil count decreased in 5 subjects (0.7%).

At primary completion, adverse events of interest reported by 5 or more subjects were:

anemia in 30 subjects (4.3%), vomiting in 5 subjects (0.7%), thrombocytopenia in 11 subjects (1.6%), neutropenia in 5 subjects (0.7%), and neutrophil count decreased in 5 subjects (0.7%).

At the end of the study, adverse events of hemorrhagic nature that occurred during the Treatment Period occurred in 11 subjects (1.6%); these were: eye hemorrhage (1 subject [0.1%], Grade 1), gastric hemorrhage (1 subject [0.1%], Grade 3), lower gastrointestinal hemorrhage (2 subjects [0.3%], both Grade 3), rectal hemorrhage (2 subjects [0.3%], both Grade 2), subdural hemorrhage (1 subject [0.1%], Grade 3), subarachnoid hemorrhage (1 subject [0.1%], Grade 3), penile hemorrhage (1 subject [0.1%], Grade 1), epistaxis (1 subject [0.1%], Grade 1), and subdural hematoma (1 subject [0.1%], Grade 3). None of these events had a fatal outcome.

Two were considered as related to radium-223 dichloride: subdural hemorrhage, and subarachnoid hemorrhage) led to study drug discontinuation.

At primary completion, adverse events of hemorrhagic nature that occurred during the Treatment Period occurred in 10 subjects (1.4%); these were: eye hemorrhage (1 subject [0.1%], Grade 1), gastric hemorrhage (1 subject [0.1%], Grade 3), lower gastrointestinal hemorrhage (2 subjects [0.3%], both Grade 3), rectal hemorrhage (2 subjects [0.3%], both Grade 2), subdural hemorrhage (1 subject [0.1%], Grade 3), subarachnoid hemorrhage (1 subject [0.1%], Grade 3), penile hemorrhage (1 subject [0.1%], Grade 1), epistaxis (1 subject [0.1%], Grade 1), and subdural hematoma (1 subject [0.1%], Grade 3). None of these events had a fatal outcome. Two were considered as related to radium-223 dichloride:

gastrointestinal hemorrhage and epistaxis. Three of these events (gastric hemorrhage, subdural hemorrhage, and subarachnoid hemorrhage) led to study drug discontinuation.

At the end of study, overall, 246 (34.7%) subjects experienced a treatment-emergent SAE during the Treatment Period (21.0% Grade 3; 4.0% Grade 4; 4.9% Grade 5). Treatmentemergent SAEs by preferred term during the Treatment Period reported by >5 subjects were:


anemia (3.2% overall; 2.5% Grade 3; 0.0% Grade 4; 0.0% Grade 5), pneumonia (1.3% overall; 1.0% Grade 3; 0.0% Grade 4; 0.1% Grade 5), sepsis (0.8% overall; 0.0% Grade 3; 0.4% Grade 4; 0.4% Grade 5), urosepsis (0.8% overall; 0.1% Grade 3; 0.6% Grade 4; 0.1% Grade 5), back pain (2.3% overall; 2.0% Grade 3; 0.0% Grade 4; 0.0% Grade 5), bone pain (1.7% overall; 1.4% Grade 3; 0.0% Grade 4; 0.0% Grade 5), spinal cord compression (2.7% overall; 2.3% Grade 3; 0.1% Grade 4; 0.0% Grade 5), hematuria (1.3% overall; 1.1% Grade 3; 0.0% Grade 4; 0.0% Grade 5), and hydronephrosis (1.0% overall; 1.0% Grade 3; 0.0% Grade 4; 0.0% Grade 5). The most common treatment-emergent gastrointestinal SAE reported in more than 5 subjects was vomiting (1.0% overall; 1.0% Grade 3; 0.0% Grade 4; 0.0% Grade 5).

At primary completion, overall, 243 (34.9%) subjects experienced a treatment-emergent SAE during the Treatment Period (21.4% Grade 3; 3.9% Grade 4; 4.9% Grade 5). Treatmentemergent SAEs by preferred term during the Treatment Period reported by >5 subjects were:

anemia (3.3% overall; 2.6% Grade 3; 0% Grade 4; 0% Grade 5), pneumonia (1.3% overall; 1.0% Grade 3; 0% Grade 4; 0.1% Grade 5), sepsis (0.9% overall; 0% Grade 3; 0.4% Grade 4; 0.4% Grade 5), urosepsis (0.9% overall; 0.1% Grade 3; 0.6% Grade 4; 0.1% Grade 5), back pain (2.3% overall; 2.0% Grade 3; 0% Grade 4; 0% Grade 5), bone pain (1.6% overall; 1.4% Grade 3; 0% Grade 4; 0% Grade 5), spinal cord compression (2.7% overall; 2.3% Grade 3; 0.1% Grade 4; 0% Grade 5), hematuria (1.3% overall; 1.1% Grade 3; 0% Grade 4; 0% Grade 5), and hydronephrosis (1.0% overall; 1.0% Grade 3; 0% Grade 4; 0% Grade 5). The most common treatment-emergent gastrointestinal SAE reported in more than 5 subjects was vomiting (1.0% overall; 1.0% Grade 3; 0% Grade 4; 0% Grade 5).

At the end of the study, additional primary malignancies during the Treatment Period were reported in 11 subjects in addition to the 9 subjects (1.3%) with reported events at primary completion: oral cavity cancer (diagnosed shortly after fourth [final] dose of study drug [exact date unknown]), squamous cell cancer (diagnosed on the day of sixth [final] dose of study drug), pseudomyxoma peritonei (diagnosed 71 days after sixth [final] dose of study drug), bladder cancer (diagnosed 26 days after fifth [final] dose of study drug), soft tissue carcinoma (diagnosed 32 days after fourth dose of study drug; subject completed 6 cycles of treatment), kidney cancer (diagnosed 12 days after first dose of study drug; subject completed 6 cycles of treatment), basal cell carcinoma (diagnosed on day of fourth dose of study drug; subject received final dose at cycle 5), primary bone cancer (diagnosed on day of fifth dose of study drug; subject completed 6 cycles of treatment), and malignant melanoma (diagnosed 13 days after fifth dose of study drug; subject completed 6 cycles of treatment). All events occurred in 1 subject each (0.1%). None of these malignancies were considered related to study drug.

At the end of the study, treatment-emergent AEs leading to discontinuation during the Treatment Period were reported in 147 subjects (20.8%); those that occurred in 1% of subjects were: anemia (2.3%), thrombocytopenia (1.6%), general physical health deterioration (3.0%), and platelet count decreased (1.4%). Gastrointestinal disorders that led to study drug discontinuation occurred in 8 subjects (1.1% overall; 0.1% Grade 1; 0.3% Grade 2; 0.6% Grade 3; 0.1% Grade 4).

At primary completion, treatment-emergent AEs leading to discontinuation during the Treatment Period were reported in 144 subjects (20.7%); those that occurred in 1% of subjects were: anemia (2.2%), thrombocytopenia (1.6%), general physical health deterioration (3.0%), and platelet count decreased (1.3%). Gastrointestinal disorders that led to study drug discontinuation occurred in 8 subjects (1.1% overall; 0.1% Grade 1; 0.3% Grade 2; 0.6% Grade 3; 0.1% Grade 4).


By the end of the study, a total of 224 (31.6%) subjects had died. At primary completion, a total of 210 (30.2%) subjects had died during the study. However, the follow-up period of the current study was short.

During the Treatment Period, most subjects had no change in the CTCAE severity Grade for chemistry parameters. The same was observed during the Follow-up Period, when most subjects had no change in the CTCAE severity Grade for chemistry parameters. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) median values showed small changes over time but the changes observed were not clinically meaningful. Bilirubin and sodium, showed minimal to no change among median values.

During the Treatment Period, in the majority of subjects, anemia, white blood cell decreased, platelet count decreased, lymphocyte count decreased, and neutrophil count decreased remained stable throughout the study with no worsening, confirming the good hematological toxicity profile of radium-223 dichloride. For lymphocyte count increased, showed small changes over time but the changes observed were not clinically meaningful.

With regard to BPI-SF scores, both at primary completion and at the end of the study, there was a nominal decrease in mean worst pain in the past 24 hours observed at every scheduled post-baseline assessment (range, -0.2 to -0.5); mean pain severity score decreased from baseline at every scheduled post-baseline assessment (range, -0.03 to -0.33); mean pain interference score decreased at every scheduled post-baseline on-treatment assessment (range, -0.10 to -0.28).

Overall conclusions In conclusion, the safety results at the end of this study confirm the favorable tolerability and safety profile of radium-223 dichloride. Median overall survival in the current study was 16 months.

Appendix to Clinical Study Synopsis

Page 1 of 12

Investigational Site List

Marketing Authorization Holder in Germany

Name Bayer Vital GmbH

Postal Address D-51368 Leverkusen

Germany

Sponsor in Germany (if applicable)

Legal Entity Name Bayer AG

Postal Address

D-51368 Leverkusen Germany

List of Investigational Sites

No Investigator Name

Facility Name Street ZIP Code

City Country

1 Prof. Dr.Michael Krainer

Allgemeines Krankenhaus der Stadt Wien

Währinger Gürtel 18-20 1090 Wien Austria

2 Prof. Dr.Irene Virgolini

Landeskrankenhaus - Universitätskliniken Innsbruck

Anichstraße 35 6020 Innsbruck Austria

3 Prof. Dr.Christian Pirich

Landeskrankenhaus Salzburg - Universitätsklinikum der PMU

Müllner Hauptstrasse 48 5020 Salzburg Austria

4 Prof. Dr.Francois JAMAR

CU Saint-Luc/UZ St-Luc Avenue Hippocrate 10 Hippocrateslaan

1200 BRUXELLES - BRUSSEL

Belgium

5 Dr.Thierry GIL Institut Jules Bordet/Jules Bordet Instituut

Boulevard de Waterloo 121

1000 BRUXELLES - BRUSSEL

Belgium

6 Dr.Nicolaas LUMEN UZ Gent De Pintelaan 185 9000 GENT Belgium

7 Dr.Nicolas WHENHAM

Clinique Saint-Pierre Avenue Reine Fabiola 9 1340 OTTIGNIES Belgium

8 Dr.Alain BOLS AZ St-Jan Brugge Oostende AV

Site St Jan A. Ruddershove 10

8000 BRUGGE Belgium

9 Dr.Ignace BILLIET AZ Groeninge Campus Vercruysselaan

Burgemeester Vercruysselaan 5

8500 KORTRIJK Belgium

10 Dr.Christophe DEROOSE

UZ Leuven Gasthuisberg Herestraat 49 3000 LEUVEN Belgium

11 Dr.Jan VAN DEN BRANDE

UZ Antwerpen Wilrijkstraat 10 2650 EDEGEM Belgium

12 Dr.Denis SCHALLIER UZ Brussel Laarbeeklaan 101 1090 BRUXELLES - BRUSSEL

Belgium

13 Dr.Derek Wilke Queen Elizabeth II Health Sciences Centre

Nova Scotia Cancer Center 5820 University Avenue Dickson Bldg. Rm 2027

B3H 2V7 Halifax Canada

14 Dr.Catherine Sperlich Hopital Charles LeMoyne CISSS de la Montérégie-Centre 3120 Boulevard Taschereau

J4V 2H1 Greenfield Park

Canada

15 Dr.Samir Patel Cross Cancer Institute 11560 University Avenue T6G 1Z2 Edmonton Canada

16 Dr.Anthony Joshua Princess Margaret Hospital-University Health Network

Department of Medical Oncology 610 University Avenue

M5G 2M9 Toronto Canada

17 Dr.Scott Tyldesley British Columbia Cancer Agency-Vancouver Centre

Radiation Oncology 600 West 10th Avenue Room 4552 Radiation Oncology Department

V5Z 4E6 Vancouver Canada


Page 2 of 12

18 Dr.Scott Berry Sunnybrook Health Sciences Centre

Odette Cancer Centre 2075 Bayview Avenue T Wing

M4N 3M5 Toronto Canada

19 Dr.Shaun Malone Ottawa Hospital-General Campus

501 Smyth Road K1H 8L6 Ottawa Canada

20 Dr.Fred Saad CHUM - Hopital Notre-Dame 1560 Sherbrooke east Pavillon Mailloux /Room K-5224

H2L 4M1 Montreal Canada

21 M. Dr. med.Dominik Berthold

Centre Hospitalier Universitaire Vaudois (CHUV)

17, Rue de Bugnon 1011 Lausanne Switzerland

22 Frau Prof. Dr.Silke Gillessen

Kantonsspital St. Gallen Rorschacher Str. 95 9007 St. Gallen Switzerland

23 Hr. Dr. med.Richard Cathomas

Kantonsspital Graubünden Loëstrasse 170 7000 Chur Switzerland

24 Hr. Dr. med.Christoph Mamot

Kantonsspital Aarau Buchser Straße 5001 Aarau Switzerland

25 Hr. Dr. med.Sacha Rothschild

Universitätsspital Basel Spitalstrasse 21 / Petersgraben 4

4056 Basel Switzerland

26 S. Dr. med.Enrico Roggero

Ospedale Regionale Bellinzona Istituto Oncologico della Svizzera Italiana

6500 Bellinzona Switzerland

27 Hr. Prof. Dr.Thomas Krause

Inselspital Universitätsspital Bern

Freiburger Str. 4 3010 Bern Switzerland

28 Hr. Dr. med.Niklaus Schäfer

Universitätsspital Zürich Rämistraße 100 8091 Zürich Switzerland

29 Mme.Marie-Laure Amram

Hôpital Cantonal Universitaire de Genève

Service d'Oncologie Département de Médecine Interne Rue Gabrielle-Perret-Gentil 4

Switzerland

30 Prof.Jitka Abrahamova

Fakultni Thomayerova Nemocnice

Videnska 800 140 59 Praha 4 Czech Republic

31 DrDavid Feltl Fakultni nemocnice Ostrava Oncology clinic 17 listopadu 1790

708 52 Ostrava Czech Republic

32 Prof.Marek Babjuk Fakultni nemocnice v Motole V Uvalu 84 150 06 Praha 5 Czech Republic

33 Prof.Milan Hora Fakultni nemocnice Plzen Dr. Edvarda Benese 13 305 99 Plzen - Bory Czech Republic

34 DrJana Katolicka Fakultni nemocnice u sv. Anny Pekarska 53 656 91 Brno Czech Republic

35 Hr. Prof. Dr.Kurt Miller

Charité Campus Benjamin Franklin (CBF)

Klinik und Poliklinik für Urologie des Universitätsklinikums Benjamin Franklin Hindenburgdamm 30

12200 Berlin Germany

36 Hr. Prof. Dr.Manfred Wirth

Medizinische Fakultät Carl Gustav Carus

Technische Universität Dresden Klinik und Poliklinik für Urologie Fetscherstraße 74

01307 Dresden Germany

37 Hr. Prof. Dr.Axel Heidenreich

Universitätsklinikum Aachen Urologische Klinik Pauwelsstraße 30

52074 Aachen Germany

38 Hr. Prof. Dr.Peter Hammerer

Städtisches Klinikum Braunschweig gGmbH

Urologische Klinik Salzdahlumer Str. 90

38118 Braunschweig Germany

39 Hr. Prof. Dr.Markus Kuczyk

Medizinische Hochschule Hannover (MHH)

Klinik für Urologie Carl-Neuberg-Str. 1

30625 Hannover Germany

40 Hr. PD Dr.Georg Bartsch

Universitätsklinikum der Johann Wolfgang Goethe Universität

Klinik für Urologie und Kinderurologie Theodor-Stern-Kai 1

60590 Frankfurt Germany

41 Hr. Dr.Michael Staehler

Klinikum der Universität München Grosshadern

Urologische Klinik und Poliklinik Marchioninistr. 15

81377 München Germany

42 Hr. Dr.Arne Strauss Universitätsmedizin der Georg-August-Universität Göttingen

Urologie Robert-Koch-Strasse 40

37075 Göttingen Germany


Page 3 of 12

43 Hr. Dr.Boris Hadaschik

Universitätsklinikum Heidelberg

Urologische Universitätsklinik Im Neuenheimer Feld 110

69112 Heidelberg Germany

44 Fr. PD Dr.Margitta Retz

Klinikum rechts der Isar Urologische Klinik und Poliklinik Ismaninger Straße 22

81675 München Germany

45 Hr. PD Dr.Christian Hampel

Universitätsmedizin der Johannes Gutenberg Universität Mainz

Urologische Klinik und Poliklinik Langenbeckstr. 1

55131 Mainz Germany

46 Hr. Dr.Martin Burmester

Vinzenzkrankenhaus Hannover gGmbH

Lange-Feld-Straße 31 30559 Hannover Germany

47 Hr. Dr.Andreas Hübner

Zentrum für Onkologie und Urologie Rostock

Trelleborger Str. 10 a 18107 Rostock Germany

48 Hr. PD Dr.Frank König

Urologische Gemeinschaftspraxis

Aturoberlin Mecklenburgische Str. 27


49 Hr. Dr. med.Wolfgang von Pokrzywnitzki

Vivantes Klinikum Am Urban Klinik für Urologie Dieffenbachstr. 1


50 Hr. Prof. Dr.Gerald Mickisch

Urologische Gemeinschaftspraxis

Robert-Koch-Str. 34 a 28277 Bremen Germany

51 Hr. PD Dr.Peter Goebell

Universitätsklinikum Erlangen Standort Waldkrankenhaus St. Marien Urologische Klinik Rathsbergerstr. 57

91054 Erlangen Germany

52 Hr. Prof. DrMartin Schostak

Medizinische Fakultät der Otto-von-Guericke Universität

Klinik für Urologie und Kinderurologie Leipziger Straße 44

39120 Magdeburg Germany

53 Hr. Prof. Dr.Arnulf Stenzl

Klinikum der Eberhard-Karls-Universität Tübingen

Universitätsklinik für Urologie Hoppe-Seyler-Str. 3

72076 Tübingen Germany

54 Hr. PD Dr.Marc-Oliver Grimm

Klinikum der Friedrich-Schiller-Universität Jena

Klinik und Poliklinik für Urologie Lessingstr. 1

07740 Jena Germany

55 Hr. Dr.Christian Arsov

Medizinische Einrichtungen der Heinrich-Heine-Universität

Urologische Klinik Moorenstr. 5

40225 Düsseldorf Germany

56 Hr.Oliver Hakenberg Universität Rostock - Medizinische Fakultät

Klinik und Poliklinik für Innere Medizin Abteilung Hämatologie und Onkologie Ernst-Heydemann-Str. 6

18057 Rostock Germany

57 Hr. Dr.Friedrich Overkamp

Oncologianova GmbH Springstraße 24 45657 Recklinghausen

Germany

58 Hr. PD Dr.Carsten Ohlmann

Universitätsklinikum des Saarlandes

Klinik für Urologie und Kinderurologie Kirrberger Str. 1

66421 Homburg Germany

59 Hr. Dr.Götz Geiges Praxis Hr. Dr. G. Geiges Lietzenburger Str. 54 10719 Berlin Germany

60 Hr. Dr.Peter Olbert Universitätsklinik Gießen und Marburg GmbH

Klinik für Urologie und Kinderurologie Baldingerstr.

35043 Marburg Germany

61 Hr. Dr.Norbert Marschner

Praxis für interdisziplinäre Onkologie und Hämatologie

Breisacher Str. 117 79106 Freiburg im Breisgrau

Germany

62 Hr. Dr.Sebastian Rogenhofer

Medizinische Einrichtungen der Universität Bonn

Klinik und Poliklinik für Urologie Sigmund-Freud-Straße 25

53105 Bonn Germany

63 Hr. Dr.Ilija Damjanoski

Universitätsklinikum Ulm Urologische Universitätsklinik und Poliklinik Prittwitzstrasse 43

89075 Ulm Germany

64 Hr. Prof. Dr.Hans Heinzer

Universitätsklinikum Hamburg Eppendorf (UKE)

Klinik und Poliklinik für Urologie Martinistr. 52

20246 Hamburg Germany

65 Hr Dr.Martin Bögemann

Universitätsklinikum Münster (UKM)

Abteilung Urologie Gebäude A1 Albert-Schweitzer-Campus

48149 Münster Germany


Page 4 of 12

1

66 Hr. Dr.Ulrich Kube Urologische Gemeinschaftspraxis

Goethestr. 5 A 09119 Chemnitz Germany

67 Fr. Dr.Laura Hoppe Klinikum der Ernst-Moritz-Arndt-Universität

Klinik und Poliklinik für Urologie Ferdinand-Sauerbruch-Str.

17475 Greifswald Germany

68 Hr. Dr.Andreas Zinke Klinikum der Ernst-Moritz-Arndt-Universität

Universitätsmedizin Greifswald Klinik und Poliklinik für Nuklearmedizin Fleischmannstraße 42 - 44

17475 Greifswald Germany

69 MDHenriette Lindberg

Herlev Hospital Onkologisk afd R Herlev ringvej 75

2730 Herlev Denmark

70 MDPeter Petersen H:S Rigshospitalet Onkologisk klinik 5073 Blegdamsvej 9

2100 København Denmark

71 MD, PhDSteinbjoern Hansen

Odense Universitetshospital Odense Universitetshospital Onkologisk afd Sdr. Boulevard 29

5000 Odense Denmark

72 Dr.Joan Carles Galcerán

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Servicio de Oncología Médica Passeig de la Vall d'Hebrón, 119-129 Edificio General, 2ª Planta

08035 Barcelona Spain

73 Dr.José Luis Pérez Gracia

Clínica Universidad de Navarra CUN

Servicio de Oncología Avda. Pio XII, 36

31008 Pamplona Spain

74 Dra.Cristina Caballero Díaz

Hospital General Universitario de Valencia

Servicio de Oncología Avda Tres Cruces, s/n

46014 Valencia Spain

75 Dra.Pilar López Criado

MD Anderson International Espanya, S.A.

Consultant of Medical Oncology Arturo Soria, 270

28033 Madrid Spain

76 Dra.María López Hospital Ramón y Cajal Servicio de Oncología Ctra. de Colmenar, Km. 9,1

28034 Madrid Spain

77 Dr.Urbano Anido Herranz

Hospital Clínico Universitario de Santiago de Compostela

Servicio de Oncología A Choupana, s/n

15706 Santiago de Compostela

Spain

78 Dr.José Manuel Trigo Pérez

Hospital Virgen de la Victoria Servicio de Oncologia Medica, Planta 1 Campus Teatinos, s/n

29010 Malaga Spain

79 Dr.José Angel Arranz Arija

Hospital General Universitario Gregorio Marañón

Servicio de Oncologia Medica, Planta 2 C/ Dr Esquerdo, 46

28007 Madrid Spain

80 Dra.Susana Hernando Polo

Fundación Hospital Alcorcón Hospital de día médico. Servico de Oncología c/ Budapest, 1

28922 Spain

81 Dr.José Maroto Rey Hospital de la Santa Creu i de Sant Pau

Servicio de Oncología C/Mas Casanovas, 90


82 Dra.Begona Mellado González

Hospital Clínic i Provincial de Barcelona

Servicio de Oncología Médica C/ Villarroel, 170


83 Dra.Aránzazu González del Alba

Hospital Universitari Son Espases

Servicio de Oncología Ctra. Valldemossa, 79

Palma de Mallorca

Spain

84 Dr.Álvaro Pinto Hospital Universitario "La Paz" Hospital de Día de Oncología Paseo de la Castellana, 261

28046 Madrid Spain

85 Dra.Ma José Méndez Vidal

Hospital Reina Sofía Servicio de oncología Avda. Menéndez Pidal, s/n

14004 Córdoba Spain

86 Dra.Nuria Laínez Hospital de Navarra Servicio de Oncología Avda. Irunlarrea, 3

31008 Pamplona Spain

87 Dr.José Luis González-Larriba

Hospital Clínico Universitario San Carlos

Servicio de Oncología Médica. Pabellón B. Planta Baja C/. Dr. Martín Lagos, s/n

28040 Madrid Spain

88 Dr.Josep Piulats Institut Català d'Oncologia Servicio de Oncologia 08907 Hospitalet de Spain


Page 5 of 12

Medica Avda.Gran Via, s/n, Km 2,7

Llobregat

89 Dr.Sergio Vázquez Hopsital Lucus Agustí Servicio de Oncología c/ San Cibrao s/n

27004 Lugo Spain

90 Dr.Ángel Rodríguez Hospital de León Servicio de Oncología Altos de Nava, s/n

24008 León Spain

91 Dr.Luis Miguel Antón Aparicio

Hospital Teresa Herrera Servicio de Oncología Carretera del Pasaje

15006 A Coruña Spain

92 Dr.Miguel Angel Climent

Instituto Valenciano de Oncología

Servicio de Oncología Médica Despacho de Ensayos Clínicos c/ Gregorio Gea, 31, 1ª Planta


93 Dr.Alberto Saenz-Cusí

Hospital Clínico Universitario Lozano Blesa

Servicio de Oncologia Medica C/ San Juan Bosco, 15

50009 Zaragoza Spain

94 Dra.Marta López Brea Hospital Universitario "Marqués de Valdecilla"

Servicio de Oncología Avda. de Valdecilla, 25

39008 Santander Spain

95 Dr.Daniel Castellano Guana

Hospital Universitario 12 de Octubre

Servicio Oncología Médica Av. de Córdoba, s/n

28041 Madrid Spain

96 Dr.Salvador Saura Hospital Dr. Negrín Barranco de la Ballena, s/n

35020 Las Palmas de Gran Canaria

Spain

97 Dr.Rocío García Domínguez

Hospital Clínico de Salamanca Paseo San Vicente, 182 37007 Salamanca Spain

98 Dr.Álvaro Montesa Hospital Regional Carlos Haya Servicio de Oncología Médica Avda. Carlos Haya s/n

29010 Málaga Spain

99 Dra.Begona Pérez Valderrama

Hospital Universitario Virgen del Rocío

Servicio de Oncología Av. Manuel Siurot, s/n

41013 Sevilla Spain

100 Dr.Miguel Ángel Cabrera

Hospital de Nuestra Señora de la Candelaria

Ctra. del Rosario, 145 38009 Santa Cruz de Tenerife

Spain

101 Dr.Juan Virizuela Echaburu

Hospital Universitario Virgen de la Macarena

Servicio de Oncología Avda. Dr. Fedriani, s/n

41071 Sevilla Spain

102 Dr.Roberto Llarena Hospital de Cruces Servicio de Oncología Pza. de Cruces, s/n

48903 Cruces/Barakaldo

Spain

103 Dr.Emilio Esteban Hospital Central de Asturias Servicio de Oncología Médica Celestino Villamil, s/n

33006 Oviedo Spain

104 Dr.Gaspar Reynes Hospital Universitari i Politècnic La Fe

Servicio de Oncología Médica Avenida de Fernando Abril Martorell, 106


105 DrTimo Joensuu Docrates Klinikka Saukonpaadenranta 2 00180 Helsinki Finland

106 Dr.Petteri Hervonen Tampereen yliopistollinen sairaala, keskussairaala

Teiskontie 35 FIN-33520

Tampere Finland

107 Dr.Tapio Utriainen HUS, Meilahden sairaala Department of Oncology Haartmaninkatu 4 Helsinki

00029 HUS Finland

108 Dr.Timo Marttila Seinäjoen keskussairaala A32 Hanneksenrinne 7

60220 Seinäjoki Finland

109 DrKalevi Pulkkanen Kuopion yliopistollinen sairaala Syöpäkeskus Puijonlaaksontie 2

70211 Kuopio Finland

110 DrMarjaana Luukkaa Turun yliopistollinen keskussairaala, kantasairaala

Oncological Department (T hospital) P.O.Box 52 Hämeentie 11

FIN-20521

Turku Finland

111 Pr.Stéphane OUDARD

Hopital Européen Georges Pompidou - Paris

Hopital Européen Georges Pompidou Service de Cardiologie 1 Ascenseur A - 3ème étage 20-40 rue Leblanc

75908 PARIS CEDEX 15

France


Page 6 of 12

112 DocteurDavid AZRIA Institut du Cancer de Montpellier

ICM - Centre Val d'Aurelle 208 rue des Apothicaires

34298 MONTPELLIER CEDEX

France

113 DrNicolas PENEL Centre Oscar Lambret - Lille Centre Oscar Lambret 3, rue Frédéric Combemale

59020 LILLE CEDEX France

114 DrFlorence JOLY Centre François Baclesse - CLCC - Caen

Centre François Baclesse Centre de Lutte Contre le Cancer Route de Lion sur Mer B.P. 5026

14076 CAEN CEDEX 5

France

115 DrCaroline ROUSSEAU

Centre René Gauducheau - Nantes

Centre René Gauducheau Boulevard Jacques Monot

44805 SAINT HERBLAIN

France

116 DrHakim MAHAMMEDI

Centre Jean Perrin 58, rue Montalembert B.P. 392

63011 CLERMONT FERRAND CEDEX 1

France

117 PrStéphane CULINE Hôpital Saint Louis - Paris Hôpital Saint Louis 1, avenue Claude Vellefaux

75010 PARIS France

118 DrSophie LEBOULLEUX

Institut Gustave Roussy - Villejuif

Institut Gustave Roussy 114 rue Edouard Vaillant

94805 VILLEJUIF CEDEX

France

119 PrThierry LEBRET Centre Médico-Chirurgical Foch

40, rue Worth 92151 SURESNES France

120 ProfesseurMarc ZERBIB

Cochin - Paris Hôpital Cochin 27, rue du Faubourg Saint-Jacques

75674 PARIS France

121 PrJean-Marc TOURANI

Centre Hospitalier Universitaire - Poitiers

Centre Hospitalier Universitaire Rue de la Milétrie

86021 POITIERS CEDEX

France

122 PrJean Philippe VUILLEZ

Centre Hospitalier Universite de Grenoble

Centre Hospitalier Universitaire de Grenoble BP 217 38043 Grenoble

38043 Grenoble France

123 DrXavier REBILLARD Clinique Beausoleil - Montpellier

Clinique Beausoleil 119 avenue Lodève

34070 MONTPELLIER

France

124 DrAbdel AZZOUZI Centre Hospitalier Universitaire - Angers

Centre Hospitalier Universitaire 4, rue Larrey

49033 ANGERS CEDEX 01

France

125 DrIvan krakowski Centre Alexis Vautrin 6 Avenue de Bourgogne 54500 Vandoeuvre les Nancy

France

126 ProfesseurArnauld VILLERS

Hôpital Claude Huriez - Lille C.H.R.U. Rue Michel Polonovsky

59037 LILLE France

127 DrFrank PRIOU Centre Hospitalier Départemental-La Roche sur Yon

Les Oudairies 85025 LA ROCHE SUR YON CEDEX

France

128 DocteurJean-Louis DAVIN

Clinique Rhone Durance - Avignon

Clinique Rhone Durance 1750 chemin Lavarin

84000 AVIGNON France

129 PrMichel SOULIE Hôpital de Rangueil - Toulouse C.H.U. Hôpital de Rangueil 1, avenue du Pr Jean Poulhes

31059 TOULOUSE cedex

France

130 DrChristopher Parker Royal Marsden NHS Trust (Surrey)

Downs Road SM2 5PT Sutton United Kingdom

131 DrOmar Din Weston Park Hospital Sheffield Teaching Hospitals NHS Foundation Trust Department of Oncology, Cancer Clinical Trials Centre Academic Unit of Clinical Oncology Broomcross Building Weston Park Hospital, Whitham Road

S10 2SJ Sheffield United Kingdom

132 DrDanish Mazhar Addenbrookes Hospital Hills Road CB2 0QQ Cambridge United Kingdom

133 DrDavid Bottomley St James' University Hospital Bexley Wing St James's Hospital

LS9 7TF Leeds United Kingdom


Page 7 of 12

Beckett Street

134 DrPrabir Chakraborti Royal Derby Hospital Derby Teaching Hospitals NHS Foundation

Royal Derby Hospital Derby Teaching Hospitals NHS Foundation Trust Uttoxeter Road

DE22 3NE

Derby United Kingdom

135 DrSarah Pascoe Derriford Hospital Department Of Oncology Derriford Hospital Derriford Road

PL6 8DH Plymouth United Kingdom

136 DrCatherine Heath Southampton General Hospital Oncology Department Southampton General Hospital Tremona Road

SO16 6YD

Southampton United Kingdom

137 DrJohn Graham Musgrove Park Hospital Musgrove Park Hospital Parkfield Drive

TA1 5DA Taunton United Kingdom

138 DrGraham (Alan) Macdonald

Aberdeen Royal Infirmary Foresterhill AB25 2ZN

Aberdeen United Kingdom

139 DrAzmat Sadozye Beatson West of Scotland Cancer Centre

1053 Great Western Road G12 0YN Glasgow United Kingdom

140 DrIsabel Syndikus Clatterbridge Centre for Oncology

Clatterbridge Road CH63 4JY

Bebington United Kingdom

141 DrSanjay Dixit Castle Hill Hospital Cancer Centre Castle Hill Hospital Castle Road, Cottingham

HU16 5JQ

Hull United Kingdom

142 DrJacob Tanguay Velindre Hospital Velindre Cancer Centre Velindre Road Whitchurch

CF14 2TL Cardiff United Kingdom

143 DrStephanie Gibbs Queens Hospital Rom Valley Way RM7 0AG Romford United Kingdom

144 DrSanthanam Sundar Nottingham City Hospital Department of Clinical Oncology Hucknall Road

NG5 1PB Nottingham United Kingdom

145 DrChristopher Scrase NRES Committee South West - Central Bristol

South West Reseach Ethics Committee Centre Level 3, Block B Whitefriars Lewins Mead

BS1 2NT Bristol United Kingdom

146 DrAmit Bahl Bristol Haematology & Oncology Centre

University Hospital Bristol NHS Foundation Horfield Road

BS2 8ED Bristol United Kingdom

147 DrIan Sayers New Cross Hospital Wolverhampton Road Heath Town

WV10 0QP

Wolverhampton

United Kingdom

148 DrPaul (Tony) Elliott Christie Hospital 550 Wilmslow Road Withington

M20 4BX Manchester United Kingdom

149 ProfessorJoseph (Joe) O'Sullivan

Belfast City Hospital Cancer Centre Belfast City Hospital Lisburn Road

BT9 7AB Belfast United Kingdom

150 DrAndrew Stockdale University Hospital Walsgrave site Clifford Bridge Road

CV2 2DX Coventry United Kingdom

151 DrRhona McMenemin Freeman Hospital Sir Bobby Robson Cancer Trials Research Centre Northern Centre for Cancer Care Freeman Hospital, Level 2, Freeman Road

NE7 7DN Newcastle Upon Tyne

United Kingdom

152 ProfessorNicholas James

Queen Elizabeth Hospital Queen Elizabeth Medical Centre Edgbaston

B15 2TH Birmingham United Kingdom

153 ProfessorValerie Lewington

Guy's Hospital Department of Nuclear Medicine Great Maze Pond

SE1 9RT London United Kingdom

154 ProfessorPeter Hoskins

Mount Vernon Hospital Department of Haematology & Oncology Rickmansworth Road

HA6 2VR Northwood United Kingdom

155 DrJulian Money-Kyrle Royal Surrey County Hospital St Luke's Oncology Centre GU2 7XX Guildford United


Page 8 of 12

Egerton Road

Kingdom

156 DrDuncan McLaren Western General Hospital Crewe Road EH4 2XU Edinburgh United Kingdom

157 DrSubramaniam Vasanthan

Leicester Royal Infirmary Infirmary Square LE1 5WW

Leicester United Kingdom

158 ProfessorFrank Sullivan

University College Hospital Galway

University Hospital Galway Newcastle Road

Galway Ireland

159 DrJerome Coffey St Luke's Hospital Highfield Road Rathgar

Dublin 6 Ireland

160 DrPaul Kelly Cork University Hospital Oncology Department Cork University Hospital Wilton

Cork Ireland

161 Dr.Wilmosh Mermershtein

Soroka University Medical Center

Yitskhak Rager Av. P.O.B 151

8410101 Beer Sheva Israel

162 Dr.Daniel Kejzman Meir Medical Center Clalit Health Services 59, Tchernichovsky Street

4428164 Kfar Saba Israel

163 Dr.Avivit Peer Rambam Health Corporation 8, Haaliya Hashniya St. 3109601 Haifa Israel

164 Prof.Avishai Sella Assaf Harofeh Medical Center Assaf Harofeh Medical Center

6093000 Zerifin Israel

165 Dr.Stephen Frank Hadassah Hebrew University Hospital Ein Kerem

Kiryat Hadassah P.O.B 12000

9112001 Jerusalem Israel

166 Dr.Eli Rosenbaum Rabin Medical Center - Beilinson Campus

39 Jabotinski Street 4941492 Petah Tikva Israel

167 Dr.Eliahu Gez Tel-Aviv Sourasky Medical Center

6 Weizmann Street 6423906 Tel Aviv Israel

168 Dr.Michael Dinerman Kaplan Medical Center Pasternak St. P.O.B. 1

7610001 Rehovot Israel

169 Dr.Raanan Berger Chaim Sheba Medical Center Chaim Sheba Medical Center Tel Hashomer

5262000 Ramat Gan Israel

170 Dr.Giovanni Paganelli IRST Istituto Scientifico Romagnolo per studio e cura Tumori

Medicina Radiometabolica Direttore: Prof. Giovanni Paganelli Via P. Maroncelli, 40 - Meldola

47014 Forlì Italy

171 Dr.Giuseppe Procopio Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Oncologia Medica 2 Dip. Oncologia Medica Via G. Venezian, 1

20133 Milano Italy

172 Dr.Caterina Messina A.O. Ospedali Riuniti Bergamo Oncologia Medica Largo Barozzi, 1

24128 Bergamo Italy

173 Prof.Massimo Aglietta IRCCS Fondazione del Piemonte per l'Oncologia

Oncologia Medica Direttore: Prof. Massimo Aglietta Istituto Ricerca e Cura del Cancro di Candiolo Strada Provinciale 142 Km 3,95 - Candiolo

10060 Torino Italy

174 Prof.Alfredo Falcone A.O.U. Pisana Oncologia Medica 2 Universitaria Direttore: Prof. Alfredo Falcone Polo Oncologico di Area Vasta Nord-Ovest - Ospedale Santa Chiara Via Roma, 67

56126 Pisa Italy

175 Dr.Annibale Versari A.O. di Reggio Emilia Medicina Nucleare Direttore: Dr. Annibale Versari Arcispedale Santa Maria Nuova Viale Risorgimento, 80

42123 Reggio Emilia Italy

176 Dr.Armando Santoro IRCCS Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

Oncologia Medica ed Ematologia Direttore: Dr. Armando

20089 Milano Italy


Page 9 of 12

Santoro Via A. Manzoni, 56 - Rozzano

177 Prof.Enrico Cortesi Azienda Policlinico Umberto I Oncologia Medica B Direttore: Prof. Enrico Cortesi Dip. Scienze Radiologiche, Oncologiche e Anatomo-Patologiche Viale del Policlinico, 155

00161 Roma Italy

178 Prof.Sergio Baldari A.O.U. Policlinico G. Martino Medicina Nucleare Dip. Diagnostica per Immagini Via Consolare Valeria

98125 Messina Italy

179 Prof.Giorgio Scagliotti A.O.U. San Luigi Gonzaga Oncologia Medica Direttore: Prof. Giorgio Scagliotti Dip. Oncologia Regione Gonzole, 10 - Orbassano

10043 Torino Italy

180 Dr.Vittorio Ferrari A.O. Spedali Civili di Brescia (ended 31Dec2015)

Oncologia Medica Direttore: Dr. Alfredo Berruti Dip. Oncologia Clinica Piazzale Spedali Civili, 1

25123 Brescia Italy

181 Dr.Manlio Cabria E.O. Ospedali Galliera Medicina Nucleare Direttore f.f. Dott. Manlio Cabria Dip. Area Diagnostica per Immagini Via A. Volta, 6 - Padiglione U

16128 Genova Italy

182 Dr.Lucia Fratino IRCCS Centro di Riferimento Oncologico - CRO

Oncologia Medica A Direttore: Prof. Umberto Tirelli Dip. Oncologia Medica Via F. Gallini, 2 - Aviano

33081 Pordenone Italy

183 Prof.Franco Silvestris A.O.U. Policlinico Consorziale Oncologia Medica Universitaria Direttore: Prof. Franco Silvestris Piazza Giulio Cesare, 11

70124 Bari Italy

184 Dr.Claudio Rossetti A.O. Ospedale Niguarda Ca' Granda (ended 31Dec2015)

Oncologia Medica Falck Dip. Oncologico Piazza Ospedale Maggiore, 3

20162 Milano Italy

185 Dr.Roberto Sabbatini A.O.U. di Modena - Policlinico Oncologia - Padiglione Beccaria Direttore: Prof. Stefano Cascinu (since 1Nov2015) Dip. Oncologia ed Ematologia (DAI 4) Via del Pozzo, 71 - Ingresso 33

41124 Modena Italy

186 Dr.Giovanni Rosti AULSS 09 Treviso Oncologia Medica Ospedale Regionale Cà Foncello Piazza Ospedale, 1

31100 Treviso Italy

187 Dr.Sergio Bracarda AUSL 8 Arezzo Centro Oncologico Direttore: Dr. Sergio Bracarda Ospedale San Donato Via P. Nenni, 20

52100 Arezzo Italy

188 Prof.Giacomo Cartenì A.O.R.N. Antonio Cardarelli Oncologia Medica Direttore: Dr. Giacomo Cartenì Dip. Oncoematologico

80131 Napoli Italy


Page 10 of 12

Via Cardarelli, 9

189 Dr.Secondo Lastoria Istituto Nazionale Studio-Cura Tumori Fondazione G. Pascale

Medicina Nucleare e Terapia Metabolica Dip. Diagnostica per Immagini, Terapia Radiante e Metabolica Via M. Semmola, 1

80131 Napoli Italy

190 Dr.Orazio Caffo APSS Trento Oncologia Medica Direttore: Dr. Enzo Galligioni Ospedale Santa Chiara Largo Medaglie d'Oro, 9

38122 Trento Italy

191 Prof.Gianmario Sambuceti

IRCCS A.O.U. San Martino IST Ist. Nazionale Ricerca Cancro

Medicina Nucleare Dip. Tecnologie Radiologiche - Ospedale San Martino Largo R. Benzi, 10

16132 Genova Italy

192 Prof.Saverio Cinieri AUSL Brindisi Oncologia Presidio Ospedaliero Di Summa-Perrino Strada Statale 7 per Mesagne

72100 Brindisi Italy

193 Prof.Carlo Ludovico Maini

IRCCS Istituti Fisioterapici Ospitalieri

Medicina Nucleare IRE Istituto Nazionale Tumori Regina Elena Via E. Chianesi, 53

00144 Roma Italy

194 Prof.Francesco Montorsi

IRCCS Fondazione San Raffaele

Urologia Istituto Scientifico Universitario San Raffaele Via Olgettina, 60

20132 Milano Italy

195 Dr.Vittorina Zagonel IRCCS Istituto Oncologico Veneto (IOV)

Oncologia Medica 1 Direttore: Dr. Vittorina Zagonel Area di Oncologia Clinica e Sperimentale Via Gattamelata, 64

35128 Padova Italy

196 Dr.Antonio Piga ASL Cagliari Oncologia Medica Direttore f.f. Dr. Efisio Defraia Ospedale Oncologico Businco Via Jenner, 1

09125 Cagliari Italy

197 Prof.Paolo Marchetti A.O. Sant'Andrea Oncologia Medica Direttore: Prof. Paolo Marchetti Dip. Scienze Oncologiche Via di Grottarossa, 1035-1039

00189 Roma Italy

198 Dr.Lucio Mango A.O. San Camillo-Forlanini Medicina Nucleare Direttore: Dr. Lucio Mango Via Portuense, 332

00149 Roma Italy

199 Prof.Evaristo Maiello IRCCS Casa Sollievo della Sofferenza

Oncologia Medica Direttore: Dr. Evaristo Maiello Dip. Onco-Ematologia Viale Cappuccini, 1 - San Giovanni Rotondo

71013 Foggia Italy

200 Prof.Carlo Antonio Mario Barone

Università Cattolica del Sacro Cuore

Oncologia Medica Direttore: Prof. Carlo Antonio Mario Barone Policlinico A. Gemelli Largo A. Gemelli, 8

00168 Roma Italy

201 Prof.Alberto Pupi A.O.U. Careggi Medicina Nucleare Biomolecolare Direttore: Prof. Alberto Pupi

50134 Firenze Italy


Page 11 of 12

Dip. Servizi - Area Diagnostica per Immagini Largo Brambilla, 3

202 Dr.Marco Ferdeghini A.O.U. Integrata Verona Medicina Nucleare Ospedale Civile Maggiore (Borgo Trento) Piazzale A.Stefani, 1

37126 Verona Italy

203 Mr. Dr.Miguel Jiménez Ríos

Instituto Nacional de Cancerología

Av. San Fernando N° 22 Col. Sección XVI Delegación Tlalpan

14080 México Mexico

204 Mrs. Dr.Raquel Gerson Cwilich

Centro de Cancer ABC Sur 128 No. 143 Col. Las Américas

01120 Mexico, D.F. Mexico

205 Dr.A.J.M. van den Eertwegh

Academisch Ziekenhuis Vrije Universiteit

Afd. Int./Oncologie, De Boelelaan 1117

1081 HV AMSTERDAM Netherlands

206 Dhr.Dr.T.A. Roeleveld

Noord West Ziekenhuisgroep-Medisch Centrum Alkmaar

Wilhelminalaan 12 Afd. Urologie

1815 JD ALKMAAR Netherlands

207 Dr.J.L.L.M. Coenen Isala Afdeling Interne Geneeskunde, Dr. van Heesweg 2

8025 AB ZWOLLE Netherlands

208 Dhr. Prof. Dr.W.J.G. Oyen

Universitair Medisch Centrum St. Radboud

Afd. Medische Oncologie Huispost 550 Geert Grooteplein 8,

6525 GA NIJMEGEN Netherlands

209 Mrs. Dr.S. Osanto Leids Universitair Medisch Centrum

Albinusdreef 2 2333 ZA LEIDEN Netherlands

210 MDDaniel Heinrich Akershus Universitetssykehus HF

Akershus Universitetssykehus Oncology dept. Sykehusveien 25

1478 Lørenskog Norway

211 Dr.Carsten Nieder Nordlandssykehuset HF Nordlandssykehuset HF, Bodø Medisinsk avdeling Postboks 1480 Besøksadresse: Prinsens gate 164

8092 Bodø Norway

212 Dr.Svein Helle Helse Bergen HF Haukeland universitetssjukehus

Oncology dept. Jonas Liesvej 65 Postbox 1

5021 Bergen Norway

213 MD, PhDSophie Fossaa

Oslo universitetssykehus HF Radiumhospitalet

Oslo universitetssykehus HF, Radiumhospitalet Postbox 4953 Nydalen Besøksadr.: Ullernchausseen 70, Montebello 0379, Oslo

0424 Oslo Norway

214 MDSigurd Oerstavik Oslo Universitetssykehus HF, Ullevål

Oslo Universitetshospital HF Kreftsenteret Kirkeveien 166

Oslo Norway

215 MDBjoerg Aksnessaether

Helse Møre og Romsdal HF Helse Møre og Romsdal HF Kreftavdelinga Åsehaugen 5

6026 Ålesund Norway

216 Prof.Tomasz Demkow

Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie

ul. W.K. Roentgena 5 ul. Wawelska 15B, 02-034 Warszawa Office address

02-781 Warszawa Poland

217 DrAnna Sowa-Staszczak

Szpital Uniwersytecki w Krakowie

ul. Kopernika 36 31-501 Krakow Poland

218 DrPiotr Jarzemski Szpital Uniwersytecki Nr 2 im. J. Bizela

Oddzial Urologii i Urologii Onkologicznej z Poddodzialem Chem. ul. Ujejskiego 75

85-165 Bydgoszcz Poland

219 Prof.Barbara Jarzab Centrum Onkologii - Instytut ul. Wybrzeze Armii Krajowej 15

44-100 Gliwice Poland

220 DrDorota Filarska Szpitale Wojewódzkie Sp. zo.o. dawny Szpital Morski im. PCK

ul. Powstania Styczniowego 1

81-519 Gdynia Poland


Page 12 of 12

221 DrTomasz Filipowski Bialostockie Centrum Onkologii im. M. Sklodowskiej-Curie

ul. Ogrodowa 12 15-027 Bialystok Poland

222 DrElzbieta Nowakowska

NZOZ Centrum Medyczne HCP Sp. zo.o.

ul. 28 czerwca 1956r. 194 61-485 Poznan Poland

223 DrElżbieta Senkus-Konefka

Uniwersyteckie Centrum Kliniczne

ul. Debinki 7 80-952 Gdansk Poland

224 Prof.Janusz Skowronek

Wielkopolskie Centrum Onkologii

ul. Garbary 15 61-866 Poznan Poland

225 DrLech Stachurski Poland

226 DrS A Ivanov Research Centre of X-ray and Radiology

Ministry of Health of the RF Urology Department ul Profsouznaya 86

117837 Moscow Russian Federation

227 Mr. Prof.Oleg Karyakin

National Medical Research Radiology Center

Department of radio surgical treatment by sheltered radionuclides 4, Koroleva st.

249036 Obninsk Russian Federation

228 Prof.Vsevolod Matveev

Russian Research Oncology Centre n.a. N.N Blokhin of RAMS

24, Kashirskoe shosse 115478 Moscow Russian Federation

229 n/a National Medical Research Radiology Center

Department of radio surgical treatment by sheltered radionuclides 4, Koroleva st.


230 n/a National Medical Research Radiology Center

Local ethical committee for clinical trials Medical Radiological Research Centre of RAMS 4, Koroleva st.


231 ProfSten Nilsson Karolinska Universitetssjukhuset i Solna

Radiumhemmet Kliniken för onkologi

171 76 Stockholm Sweden

232 MD, PhDJan Tennvall Skånes Universitetssjukhus Getingevägen 4 221 85 Lund Sweden

233 DrAnna Laurell Akademiska Sjukhuset Onkologmottagningen 751 85 Uppsala Sweden

234 DocMaria Albertsson Universitetssjukhuset i Linköping

Onkologiska kliniken Garnisonsvägen 10

581 85 Linköping Sweden

235 Dr.Camilla Thellenberg Karlsson

Norrlands Universitetssjukhus, Umeå

Cancercentrum, NUS 901 85 Umeå Sweden

236 DrMats Andén Länssjukhuset i Kalmar Onkologienheten / Kirurgiska kliniken

391 85 Kalmar Sweden

237 DrLars Beckman Länssjukhuset Sundsvall-Härnösand

Onkologkliniken 851 86 Sundsvall Sweden

238 DrJana Orlovskaja Mälarsjukhuset Onkologkliniken Sörmland Klostergatan 28

633 52 Eskilstuna Sweden

239 DrClaes Ginman Centralsjukhuset i Karlstad Onkologkliniken 651 85 Karlstad Sweden

240 MDBo Lennernäs Sahlgrenska Universitetssjukhuset

Jubileumskliniken Allmän onkologi

413 45 Göteborg Sweden

241 DrBengt Johansson Örebro Universitetssjukhus Onkologiska kliniken 715 92 Örebro Sweden


Product Identification Information

Product Type

Drug

US Brand/Trade Name(s)

Xofigo

Brand/Trade Name(s) ex-US

Xofigo

Generic Name

radium Ra 223 dichloride

Main Product Company Code

BAY88-8223

Other Company Code(s)

Alpharadin

Chemical Description

Radium-223 dichloride

Other Product Aliases

Radium-223 chloride

Date of last Update/Change: 09 Jul 2015

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