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![Page 1: Post-operative Radiation Therapy following Radical Prostatectomy for Prostate Cancer Stephen Ko, M.D. Mayo Clinic Jacksonville.](https://reader036.fdocuments.us/reader036/viewer/2022062407/56649ced5503460f949ba68f/html5/thumbnails/1.jpg)
Post-operative Radiation Therapy following Radical Prostatectomy for Prostate
Cancer
Stephen Ko, M.D.
Mayo Clinic Jacksonville
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Prostate Cancer
• One third of patients undergo radical prostatectomy as initial therapy
• 25-33% of patients are at risk of treatment failure following radical prostatectomy
• 60-70% will develop metastatic disease within 10 years without further treatment
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Post-operative Radiation Therapy following Radical Prostatectomy
• Adjuvant radiotherapy – presence of adverse factors – undetectable PSA
• Salvage Radiotherapy – rising PSA
• Salvage Radiotherapy – clinically apparent recurrent tumor in the prostatic fossa
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Adjuvant Radiation Therapy Rationale
• Residual disease in the prostatic fossa is the primary cause of treatment failure
• A substantial number of cells may be present before PSA is detectable
• Greatest opportunity for cure exists when the cells are fewest in number and localized
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Adjuvant Radiation Therapy Declining in Utilization
12% 1998-2000
7% 2004-2005
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Adjuvant Radiation Therapy Pathologic Indications
• Extraprostatic extension
• Seminal Vesicle invasion
• Positive Surgical Margins
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Adjuvant Radiation Therapy Prospective Randomized Clinical Trials
Study No. Years Patients
SWOG 8794 1988-1997 425
EORTC 22911 1992-20011005
ARO 9602 1997-2004 268
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Adjuvant Radiation TherapyEligibility
SWOG EORTC ARO
Exraprostatic extension
+ S.V.
+ Margins
Undetectable PSA
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Adjuvant Radiation Therapy Endpoints
SWOG EORTC ARO
Biochemical Relapse Free
survival
Local Relapse
Metastasis Free Survival
Overall Survival
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Adjuvant Radiation Therapy Results
Freedom Biochemical
from
RelapseLocal Control
RP RP+RT RP RP+RTActuarial Endpoint
ARO 54 72* NS NS 5 yrs
EORTC 53 74* 85 95* 5 yrs
SWOG 44 72* 78 92* 5 yrs
25 51* 78 92* 10 yrs
*Statistically significant with RT
All numbers are in percentages
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Adjuvant Radiation Therapy Results
Clinical
Free
Disease
SurvivalMetastasis
SurvivalFree
Overall Survival
RP RP+RT RP RP+RT RP RP+RTActuarial Endpoint
ARO NS NS NS NS 95 97 5 yrs
EORTC 81 91* 94 94 93 92 5 yrs
SWOG 70 84* 82 87 90 91 5 yrs
49 70* 61 71* 66 74* 10 yrs
*Statistically significant with RT
All numbers are in percentages
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Radical Prostatectomy Adjuvant Androgen Suppression
Study Outcome
+ Pelvic Lymph Nodes
Messing Prospective Randomized
Improved Survival
+S.V., +Margins,
Extracapsular extension
RTOG 8531 – Subset Analysis
Improved Survival
MRC PR 10 Accruing
EORTC 22043-33041 Accruing
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Post-operative Radiation Therapy following Radical Prostatectomy
• Adjuvant radiotherapy – presence of adverse factors – undetectable PSA
• Salvage Radiotherapy – rising PSA
• Salvage Radiotherapy – clinically apparent recurrent tumor in the prostatic fossa
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Salvage Radiotherapy
• PSA Serum Half-Life = 3.1 days
• PSA should be undetectable > 4 weeks after RP
• Biochemical Relapse– AUA > 0.2, twice consecutively– Stephenson > 0.4, twice consecutively
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Radical Prostatectomy: Biochemical RelapseFactors Associated with Metastatic Disease and Death
• Persistently elevated PSA after Prostatectomy• Shorter interval from surgery to biochemical
relapse• Shorter PSA doubling time• Higher Gleason Scores• Higher GPSM Scores• Non-diploid tumor DNA
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Radical Prostatectomy GPSM Scoring Algorithm
GPSM – Prostatectomy Gleason Score
+ 1 (Pre-op PSA 4-10)
+ 2 (Pre-op PSA 10.1-20)
+ 3 (Pre-op PSA >20)
+ 2 (+S.V. or +Nodes)
+ 2 (Positive Surgical Margins)
GPSM score of >10: Increased biochemical relapse; Increased risk of death
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GPSM Scoring Outcomes
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Radical Prostatectomy:Post-op PSA kinetics (doubling time)
• PSA Working Group Guidelines for PSAdt calculations
• >3 PSA values which are >0.2 ng/ml and increasing within 12 months
• Stable testosterone levels (not recovering from androgen suppression)
• Relationship of PSAdt clinical relapse and mortality – continuum
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Radical Prostatectomy:PSA doubling time
• Strongly associated with clinical relapse• PSAdt <3 months: Short life expectancy• PSAdt <12 months: 50-75% of patients with
clinical relapse within 10 years• PSAdt <15 months: 90% deaths due to prostate
cancer• PSAdt >15 months: 33% deaths due to prostate
cancer
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Radical Prostatectomy:Biochemical Relapse
• Abnormal CT is rare with: – PSA < 5-10 ng/ml– PSAdt > 6-10 months
• Abnormal bone scan is rare with:– PSA < 10 ng/ml
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Radical Prostatectomy:Biochemical Relapse – MRI findings
Sensitivity Specificity Accuracy
• Endorectal MR 84-95% 89-100% 86-94%
• Local Recurrence averaged 1.5 cm in diameter
• Patients typically had PSA levels > 2 ng/ml
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Biochemical RelapseMRI sites of Recurrence
• Vesicourethral anastomosis: 44%
• Retrovesicle space: 30%
• Seminal vesicle region: 23%
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Biochemical Relapse:Salvage Prostate Bed Radiation Therapy Results
Author Pt., No.Salvage RT
Dose Median (Gy)
Biochemical Response % BCR-free%
Endpointactuarial
Neuhof 171 63.0 83 35 5-yr
Ward 211 64.0 90 48-66 5-yr.
Brooks 114 64.0 69 33 6-yr.
Stephenson 1540 64.8 59 32 6-yr.
Maier 170 68.0 - 44 7-yr.
Buskirk 368 64.8 - 30 8-yr.
Pazona 223 63.0 73 25 10-yr.
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Salvage Prostate Bed Radiation Therapy Prognostic Factors
• Prostatectomy Gleason Score• Tumor DNA ploidy• Persistently detectable post-op PSA• PSA level before prostatectomy• PSAdt postoperatively• Surgical Margin status• Seminal vesicle invasion• Pelvic lymph node involvement• Delay in initiation of salvage RT
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Salvage Prostate Bed Radiation Therapy Prognostic Scoring Systems
• Stephenson Nomogram
• Mayo Scoring System
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Stephenson Nomogram
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Stephenson Algorithm
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Mayo Scoring System
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Mayo Scoring System
Points 5y BCR
0-1 69%
253%
326%
4-5 6%
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Dose Response Analysis
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Dose Response PSA <0.6
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Dose Response >0.6
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Salvage Radiation Therapy +/- Androgen Suppression
• RTOG 9601 – Prostate fossa– RT + placebo– RT + bicalutamide
• RTOG 0534– Prostate fossa RT– Prostate fossa RT with androgen suppression– Prostate fossa + Node RT with androgen suppression
• Japan Clinical Oncology Group 0401– Prostate fossa RT– Prostate fossa RT + bicalutamide
• Medical Research Council PR 10– Prostate fossa RT– Prostate fossa RT + 6 months androgen suppression– Prostate fossa RT + 2 years androgen suppression
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Salvage Radiation TherapyConsensus Based Guidelines
• Organizations which support offering salvage RT to all men with a detectable PSA– NCCN– European Association of Urology– European Society of Medical Oncology– Australian and New Zealand Radiation Oncology
Genito-Urinary Group
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Post-operative Radiation Therapy following Radical Prostatectomy
• Adjuvant radiotherapy – presence of adverse factors – undetectable PSA
• Salvage Radiotherapy – rising PSA
• Salvage Radiotherapy – clinically apparent recurrent tumor in the prostatic fossa
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Radical Prostatectomy Clinically-Apparent Local Recurrence
Author Pt, No. RT Dose Median (Gy)
Local control % BCR-free% Actuarial
Endpoint
Koppie 34 68.4 - 39 3 yrs
Cadeddu 25 64.0 - 14 5 yrs
Choo 44 63.0 97 11 5 yrs
Macdonald 42 68.4 95 27 5 yrs
Wiegal 20 65.0 95 68 5 yrs
vander Kooy 35 64.0 97 56 8 yrs
Syndikus 26 52.0 54 - 10 yrs
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RTOG guidelines salvage RT
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Positive apical margin + bCR
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ECE + SVI
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Dose Constraints
Rectum Bladder Femori Comments
RTOG 0534V40<45%
V65<25%
V40<60%
V65<40%V50<10%
Rectum:rectosigmoid junction ischium; bladder: entire; femori: head intertrochanter
Cozzarrini
V50<63%
V55<57%
V60<50%
- -Rectum: rectosigmoid junction anal verge
Fonteyne
V40<84%
V50<68%
V60<59%
V65<48%
- -Rectal wall: 0.6 cm superior to target volume inferiorly
SidhomV40<60%
V60<40%- -
Rectum: rectosigmoid junction 1.5 cm inferior of CTV
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Post-op Prostate Bed Radiation Therapy Adverse Effects
• Early: During RT or within 90 days of RT completion
• Late: Effects which occur or persist after 90 days of RT completion
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Post-op Prostate Bed Radiation Therapy Adverse Effects
• Prognostic Factors– Antecedent Surgery– RT Treatment Planning– RT Treatment Techniques– RT Dose Volumetric Perimeters– Imaging and localization methods
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Post-op Prostate Bed Radiation Therapy Early Adverse Effects
• Dysuria
• Urgency/Frequency
• Proctalgia
• Increased daily stools
• Hematochezia
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Post-op Prostate Bed Radiation Therapy Early Adverse Effects
• Prognostic Factors– Rectal dose– Pelvic nodal RT– Diabetes Mellitus– Hemorrhoids– Androgen Suppression– Anticoagulant Use
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Post-op Prostate Bed Radiation Therapy Late Adverse Effects
• Late grade >2 adverse events is <20% at 5 years
• Prevalence is considerably less as many adverse events are not chronic
• Severe events are <1%
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Post-op Prostate Bed Radiation Therapy Late Adverse GI Effects
• Increased or urgent stools/tenesmus• Proctalgia• Hematochezia• Mucous discharge• Rectal stricture• Fecal incontinence (0.2%)• Five-year incidence of >2 GI events is <5%• Severe GI events are uncommon <1%
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Post-op Prostate Bed Radiation Therapy Late Adverse GU Effects
• Difficult to accurately attribute late GU effects causality because both surgery and RT contribute
• Incidence of grade >2 late effects is approximately 10%
• Bladder Neck Contracture• Urethral stricture 5%• Dysuria• Transient hemturia (5%)
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Post-op Prostate Bed Radiation Therapy Late Adverse GU Effects
• Urinary incontinence is comparable to surgery alone
• If urinary incontinence occurs, it is typically of mild, stress-induced nature
• RT does not appear to diminish erectile dysfunction in men who undergo nerve-sparing prostatectomy
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Post-op Prostate Bed Radiation Therapy –Late Side Effects
• Mayo Clinic Jacksonville
• Retrospectively reviewed 308 patients who received salvage radiation therapy for a detectable PSA after prostatectomy– Aim: Evaluate the nature and severity of late
GI and GU toxicity associated with salvage radiation therapy
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Post-op Prostate Bed Radiation Therapy –Late Side Effects
Mayo Clinic Jacksonville
• GU toxicity– Grade 2: 7.7%– Grade 3-4: 1%
• Included 3 patients with cystitis
– 14 of 18 patients who developed urethral strictures required dilatation
– 3.4% of patients had worsening urinary control
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Post-op Prostate Bed Radiation Therapy –Late Side Effects
Mayo Clinic Jacksonville
• GI toxicity– Grade 2: 1.3%– Grade 3-4: 0.3%
• Included one patient that required a diverting colostomy
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Comparison of Late GI Toxicity
Pro/Retrospective Adjuvant/Salvage
Trials
# pts. F/U mths.
Grade 2
Grade 3
Grade 4
Our results 308 61 1.3% 0% 0.3%
Bolla et al.
EORTC 22911
1005 45 2.5%
Thompson et al.
SWOG 8794
214 127 3.3%
Feng et al. 959 55 4% 0.4% 0.3%
Zelefsky et al. 42 24 5%
Choo et al. 98 50 4% 0%
Forman et al. 50 16 - 0%
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Post-op Prostate Bed Patient Reported Quality of Life
• Pinkawa et al. (Modern salvage RT technology)– Reduced urinary frequency and bother only at end of
RT– Reduced bowel function and bother was reported
through 2 months, but not thereafter