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Clinical Trial
. 2015 Jul;116(1):50-6.
doi: 10.1111/bju.12676. Epub 2015 Apr 17.

Long-term oncological outcomes of a phase II trial of neoadjuvant chemohormonal therapy followed by radical prostatectomy for patients with clinically localised, high-risk prostate cancer

Jonathan L Silberstein  1 , Stephen A Poon  2 , Daniel D Sjoberg  3 , Alexandra C Maschino  3 , Andrew J Vickers  3 , Aaron Bernie  4 , Badrinath R Konety  5 , W Kevin Kelly  6 , James A Eastham  4
Affiliations
Clinical Trial

Long-term oncological outcomes of a phase II trial of neoadjuvant chemohormonal therapy followed by radical prostatectomy for patients with clinically localised, high-risk prostate cancer

Jonathan L Silberstein et al. BJU Int. 2015 Jul.

Abstract

Objective: To determine long-term oncological outcomes of radical prostatectomy (RP) after neoadjuvant chemohormonal therapy (CHT) for clinically localised, high-risk prostate cancer.

Patients and methods: In this phase II multicentre trial of patients with high-risk prostate cancer (PSA level >20 ng/mL, Gleason ≥8, or clinical stage ≥T3), androgen-deprivation therapy (goserelin acetate depot) and paclitaxel, carboplatin and estramustine were administered before RP. We report the long-term oncological outcomes of these patients and compared them to a contemporary cohort who met oncological inclusion criteria but received RP only.

Results: In all, 34 patients were enrolled and followed for a median of 13.1 years. Within 10 years most patients had biochemical recurrence (BCR-free probability 22%; 95% confidence interval [CI] 10-37%). However, the probability of disease-specific survival at 10 years was 84% (95% CI 66-93%) and overall survival was 78% (95% CI 60-89%). The CHT group had higher-risk features than the comparison group (123 patients), with an almost doubled risk of calculated preoperative 5-year BCR (69% vs 36%, P < 0.01). After adjusting for these imbalances the CHT group had trends toward improvement in BCR (hazard ratio [HR] 0.76, 95% CI 0.43-1.34; P = 0.3) and metastasis-free survival (HR 0.55, 95% CI 0.24-1.29; P = 0.2) although these were not statistically significant.

Conclusions: Neoadjuvant CHT followed by RP was associated with lower rates of BCR and metastasis compared with the RP-only group; however, these results were not statistically significant. Because this treatment strategy has known harms and unproven benefit, this strategy should only be instituted in the setting of a clinical trial.

Keywords: chemotherapy; hormone therapy; neoadjuvant; prostate neoplasms; radical prostatectomy; survival.

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Figures

Figure 1
Figure 1
Biochemical recurrence-free probability for patients treated for high-risk prostate cancer treated with chemohormonal therapy and RP in a phase II multicenter trial (solid, n=33) compared to patients treated with RP alone (dashed, n=122), adjusted for the Kattan risk score (HR 0.76, 95% CI 0.43, 1.34; p=0.3).
Figure 2
Figure 2
Metastatic disease-free probability for patients treated for high-risk prostate cancer treated with chemohormonal therapy and RP in a phase II multicenter trial (solid, n=34) compared to patients treated with RP alone (dashed, n=122) , adjusted for the Kattan risk score (HR= 0.55, 95% CI 0.24, 1.29; p=.2).
See this image and copyright information in PMC

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