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Is Radical Prostatectomy Adequate For High Risk Prostate Cancer?
Dr Manish Patel Urological Cancer Surgeon Westmead Hospital University of Sydney
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What is High Risk High Risk For Recurrence and Progression following Definitive Therapy. Localised High Risk Gleason score 8-10 PSA >20ng/ml Locally Advanced Clinical T3 Lymph node positive Excluded: Clinical T4 N2 or distant metastatic disease
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Guidelines EAU AUA NCCN
Option: Although active surveillance, interstitial prostate brachytherapy, external beam radiotherapy, and radical prostatectomy are options for the management of patients with high-risk localized prostate cancer, recurrence rates are high. NCCN For: cT3a or Gleason 8-10 or PSA>20ng/ml Radical prostatectomy (selected patients with no fixation, low volume, + plevic lymph node dissection.) ADT + XRT (3 years)
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High Risk- Localised Prostate Cancer Down Grading is Common
Donohue et.al. –MSKCC 238 Men had biopsy Gleason score % had Gleason score <7 in prostate specimen. Manoharan et.al- 31% down grading Grossfeld et.al. -38% down grading
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High Risk- Localised Prostate Cancer
Very significant BFS in men down graded compared to Gleason 8-10. Also Bastian et.al. A 1/3 of men with biopsy GS 8-10, may actually have less aggressive disease.
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Outcomes of High Risk Localised CaP-RRP Pathological Outcomes
Study No. pT3 SVI Lymph node mets Positive margins Donohue et.al. (MSKCC) 238 33% 27% 20% 32% Mian et.al. (MD Andersen) 188 24% 9% 6% Manoharen et.al (Uni Miami) 79 43% 29% 2% 46% Serni et.al. (Uni of Florence) 116 39% 15%
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Outcomes of High Risk Localised CaP-RRP
Study No. 5 yr BFS 10 yr BFS Donohue et.al. (MSKCC) 238 51% 39% Mian et.al. (MD Andersen) 188 71% 55% (7 years) Manoharen et.al (Uni Miami) 79 68% Serni et.al. (Uni of Florence) 116 78%
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Outcomes of High Risk Localised CaP-RRP
Mian et.al. Organ confined disease has good outcome
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High Risk Localised CaP-RRP
All patients 453 Patients Henry Ford Health System All Prostate cancer- Gleason Score >7 Analyses survival Propensity score analysis Surgery is better for all co-morbidities. Median OS RRP: 9.7 yrs RT: 6.7 yrs Cons: 5.2yrs Low Charlson Score High Charlson Score
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Disease Specific Survival
SEER database of prostate Cancer Treatments Population based approach. 9965 with Localised Gleason Score 8-10 prostate Cancer Treatment No. 10 year %DSS (95%CI) Radical Prostatectomy 4154 76 (71-80) Radiation Therapy 2977 52 (46-57) Watchful Waiting 2834 43 (38-48) Lu et.al.
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Multimodality Therapy Neoadjuvant Hormone Therapy
Cytoreduction (2 trials with 3 month NHT) More organ confine disease Fewer positive margins No PSA PFS benefit. (Not powered for it, not enriched with high risk) Klotz et.al. did find PSA prgression benefit for men with PSA>20ng/ml. Neoadjuvant Chemo Small phase II trials only No PSA progression or survival advantage Ongoing CALGB trial of Docetaxel and Estramustin.
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Adjuvant Radiation 2 Randomised Trials of higher risk
Biochemical PFS 2 Randomised Trials of higher risk Patients randomised to observation or adjuvant XRT Eligible patients were: SM+, ECE, SVI Results: BPFS and clinical progression were significantly lower in XRT No survival benefit demonstrated No data on adjuvant vs EARLY Salvage XRT Bolla Et.al. Hazard Ratio for XRT treatment SVI: SM ECE 0.50
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Adjuvant Hormone Therapy
EPC studies 150 mg Bicalutamide 3 randomised studies through the world. Significant PSA PFS if 150 mg Bicalutamide added after RRP for lacally advanced or high risk CaP. No difference with localised CaP Survival is not altered. Risk Group No. HR (95% CI) Locally advanced 1719 0.42 ( ) N+ 74 0.11 ( ) GS 7-10 1959 0.48 ( ) PSA>10ng/ml 1636 0.40 ( )
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Adjuvant Chemotherapy
Adjuvant Taxotere +LHRH in High risk CaP after RRP Closed- poor accrual Adjuvant Taxotere following High risk CaP after RRP- VA study Accruing.
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Locally Advanced Prostate Cancer
176 with cT3 CaP Pathology Down staging is common. 24% pathological down staging (pT2)with monotherapy 41% with NHT Stage PSA Gleason Score T3a (85%) SVI (15%) Median (12.7ng/ml) 25% (2.6ng/ml) 75% (26ng/ml) <6 (47%) 7 (38%) 8-10 (15%) Organ Confined ECE SVI LNI SM+ 30% 61% 34% 19% 27%
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Locally Advanced Prostate Cancer
BCR Death 48% 44% 24% 15% 6% Median follow up 4.6 years. 77% with BCR Tx with HT Clinical failure only in 36% of BCR. 10 year freedom from clinical failure= 76%
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Locally Advanced Prostate Cancer Results From Other Centers-Monotherapy
Study Selection No. 5 yr CSS 10yr CSS 5 yrs OS 10 yr OS Carver et.al. All 176 94% 85% 88% 75% Gerber et.al 345 57% GS<7 73% GS 7 67% Van Den Oouden et.al. GS<8 83 72% 60% Gontero et.al 51 93% 76%
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Morbidity of RRP for advanced disease No Worse Than clinically Localised Disease
Outcome Clinically OC (n=152) Locally Advanced (n=51) Sig Transfusion (mean per Pt) 2.5 1 0.02 OT time (min) 140 168 0.001 Lymphocele % 3 12 0.04 Bladder Neck Contracture % 18 27 0.21 Full continence 78% 80% 0.91 Severe incontinence 10% 16% 0.2 Gontero et.al.
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The Value of Extended Lymphadenectomy In High Risk Disease.
Nomograms have limited use. CT and MRI only sensitive in 10-30% Sentinal node biopsy with radiolabelling and gamma probe has problems Unable to detect nodes in area unexplored. SPECT imaging after intraprostatic injection under evaluation. high resolution MRI with lymphotrophic superpara-magentic nanoparticles has promise but not routinely available.
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Heidenreich et.al reported ePLND detects 24% vs 12% positive LNs.
Wowroshek et.al. gain an additional 35% LN+ pts with ePLND. Studer et.al. 24% LN+ with ePLND. 58% along Internal I Artery 19% only in IIA
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ePLND is therapuetic All patients LN- Patients
Konety et.all (SEER Data All patients who have greater than 4 LN removed benefit. Similar Result observed by MSKCC series
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RRP is adequate for High Risk Cancer
Better with Organ confined Low PSA ePLND SM- Locally Advanced Better with lower GS Lower PSA
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Surgery+ Hormones vs XRT+Hormones
79% 89% Messing et.al Bolla et.al N=91 LN+ after RRP High Risk (GS>8 or pT3)
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5yrs CSS of all patients with LN+ was 74%
BCR CSS
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