Prostate VTP: Clinical Trial Update Katie S. Murray, D.O. Urological Oncology April 24, 2015.
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Transcript of Prostate VTP: Clinical Trial Update Katie S. Murray, D.O. Urological Oncology April 24, 2015.
Prostate VTP: Clinical Trial Update
Katie S. Murray, D.O.Urological Oncology
April 24, 2015
WST-11 (TOOKAD® SOLUBLE )
• Novel Class of photosensitizers derived from Chlorophyll
• Non-thermal localized treatment effect • Water soluble, binds albumin
• Rapid Clearance (t1/2 = 37 minutes)
• IV Administration (4 mg/kg)• Laser fibers pre-positioned using brachy
template• Light Activation of WST-11 at 753 nm• Patient discharged after 6 hours
PHASE II
155 patients:
PCM 201: 40 patients (Europe – Canada)
PCM 202: 30 patients (United States)
PCM203: 85 patients (Europe)
PCM 301 - EuropeOpen label study randomized
vs Active Surveillance
400 patients (200 /arm)Recruitment complete (n=413)
TOOKAD® Soluble-WST11Clinical Trials (Prostate Cancer)
PHASE III
PCM 304- Latin AmericaOpen label single arm study
80 patients
Recruitment complete (n=81)
Clinical Trial Program
Phase 2 Studies: Trial Endpoints
• Pathologic– Negative biopsy in the treated lobe at Month 6
• Serious Adverse Events (SAEs)– Graded SAEs, QOL (IPSS, IIEF)
• Markers
– Volume of hypoperfusion area shown by MRI at Day 7
– Serum PSA levels and PSA changes from baseline at 6 months
Phase 2 Studies
Patients treated unilaterally with
optimal conditions:
4 mg/kg-200 J/cm
Mean % Necrosis*
Negative biopsies
n (%)
PCM 201 8 99.0% 7 (87.5%)
PCM 202 15 74.3 % 11 (73.3%)
PCM 203 42 90.7% 34 (81.0%)
All studies 65 87.6% 52 (80.0%)
* Mean % Necrosis = Volume of necrosis/ Vol prostate pre+post treatment/2
TOOKAD® Soluble Phase II Studies
Erectile Function and Urinary Symptoms
Baseline Month 1 Month 3 Month 6 (n = 149) (n = 149) (n = 147) (n = 150)
18.8
13.7
15.7
7.0
8.5
5.6 5.4
15.4
20
15
10
5
Mean IIEF-5 score (max = 25) and Mean IPSS score (max = 35) 25
IIEF score
IPSS score
TOOKAD® Soluble – Quality of Life Outcomes
Adverse events
Adverse events in phase II patients treated with 4 mg/kg
N = 117
Dysuria 39 (33.3%)
Perineal pain/Hematoma 18 (15.4%)
Hematuria 16 (13.7%)
Urinary retention 13 (11.1%)
Urinary urgency 11 (9.4%)
Polyuria 9 (7.7%)
Urinary tract infection 7 (6.0%)
Prostatitis 5 (4.3%)
Hematospermia 5 (4.3%)
TOOKAD® Soluble - Safety profile
No Fistulae, No Phototoxicity, No Severe Incontinence
TOOKAD® Soluble Phase II studies
Long term Follow-up
123 Patients in post-study follow-up :
o 95 (77%) patients are still actively followed
o 24 (20%) patients have undergone further whole gland therapies for prostate cancer, including:
- 16 Radical prostatectomy - 7 Brachytherapy- 1 HIFU
o 4 (3%) patients are lost to follow-up
Summary: Phase II TrialsFocal Treatment with WST-11 VTP
Feasible and Safe for Hemiablation and Bilateral Tx– Efficacy Approx. 80% in treated site (by biopsy)– Retreatment also suggests ≈ 80% efficacy– Well Tolerated
• Urinary Function• Erectile Function
• Adverse Events– Results of Phase 3 studies anticipated– Long Term Outcomes are pending (48 mos)