Multimodal treatment for high-risk prostate cancer with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel and long-term androgen deprivation therapy: results of a prospective phase II trial

Andrea Guttilla, Roberto Bortolus, Gianluca Giannarini, Pirus Ghadjar, Fabio Zattoni, Michele Gnech, Vito Palumbo, Francesca Valent, Antonio Garbeglio, Filiberto Zattoni, Andrea Guttilla, Roberto Bortolus, Gianluca Giannarini, Pirus Ghadjar, Fabio Zattoni, Michele Gnech, Vito Palumbo, Francesca Valent, Antonio Garbeglio, Filiberto Zattoni

Abstract

Background: The optimal management of high-risk prostate cancer remains uncertain. In this study we assessed the safety and efficacy of a novel multimodal treatment paradigm for high-risk prostate cancer.

Methods: This was a prospective phase II trial including 35 patients with newly diagnosed high-risk localized or locally advanced prostate cancer treated with high-dose intensity-modulated radiation therapy preceded or not by radical prostatectomy, concurrent intensified-dose docetaxel-based chemotherapy and long-term androgen deprivation therapy. Primary endpoint was acute and late toxicity evaluated with the Common Terminology Criteria for Adverse Events version 3.0. Secondary endpoint was biochemical and clinical recurrence-free survival explored with the Kaplan-Meier method.

Results: Acute gastro-intestinal and genito-urinary toxicity was grade 2 in 23% and 20% of patients, and grade 3 in 9% and 3% of patients, respectively. Acute blood/bone marrow toxicity was grade 2 in 20% of patients. No acute grade ≥ 4 toxicity was observed. Late gastro-intestinal and genito-urinary toxicity was grade 2 in 9% of patients each. No late grade ≥ 3 toxicity was observed. Median follow-up was 63 months (interquartile range 31-79). Actuarial 5-year biochemical and clinical recurrence-free survival rate was 55% (95% confidence interval, 35-75%) and 70% (95% confidence interval, 52-88%), respectively.

Conclusions: In our phase II trial testing a novel multimodal treatment paradigm for high-risk prostate cancer, toxicity was acceptably low and mid-term oncological outcome was good. This treatment paradigm, thus, may warrant further evaluation in phase III randomized trials.

Trial registration: ClinicalTrials.gov NCT00116142 NCT01603420 NCT01811810.

Figures

Figure 1
Figure 1
Kaplan-Meier estimates of a) biochemical recurrence-free survival and b) clinical recurrence-free survival.

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