Phase 2 Randomized Study of Radiation Therapy and 3-Year Androgen Deprivation With or Without Concurrent Weekly Docetaxel in High-Risk Localized Prostate Cancer Patients

Joan Carles, Enrique Gallardo, Montserrat Doménech, Albert Font, Joaquim Bellmunt, Mariona Figols, Begoña Mellado, María Isabel Sáez, Cristina Suárez, María José Méndez, Pablo Maroto, Raquel Luque, Teresa de Portugal, Ramón Aldabo, Teresa Bonfill, Rafael Morales-Barrera, José García, Sonia Maciá, Xavier Maldonado, Palmira Foro

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5 Citations (Scopus)

Abstract

© 2018 Elsevier Inc. Purpose: Docetaxel improves survival in patients with metastatic prostate cancer. This randomized phase 2 trial aimed to assess the activity of weekly docetaxel with radiation therapy (RT) plus androgen deprivation in patients with high-risk localized prostate cancer. The study examined the benefit of 9 weekly docetaxel administrations to RT plus 3 years of luteinizing hormone-releasing hormone analogues. Methods and Materials: A total of 132 patients were recruited for the study. Patients’ characteristics included T3-T4 stage (81.1%), Gleason score ≥8 (77.3%), prostate-specific antigen level >20 ng/mL (28.9%), and pN+ (18.2%). All patients included in the trial received either the standard-of-care control arm with luteinizing hormone-releasing hormone analogues plus RT (arm A) or the experimental arm (RT + 9 weekly cycles of docetaxel + 3 years of androgen deprivation therapy, arm B). The primary objective was to achieve a high percentage of patients who were free of biochemical recurrence within 5 years of randomization. Secondary endpoints included biochemical recurrence-free survival (BRFS), progression-free survival (PFS), overall survival (OS), clinical response rate, biochemical response rate, and toxicity. Results: No difference between the arms of the study was found in biochemical recurrence (93.4% at 60 months for arm A vs 85.3% for arm B; P =.3297). PFS at 60 months was 93.4% and 83.7% in arms A and B, respectively (P =.2532). Five-year survival was 93.3% (95% confidence interval, 83.1-97.45) in arm A versus 93.6% (83.8-97.55) in arm B; median PFS and OS have not been reached. Prostate-specific antigen level ≤0.2 ng/mL at 3 months after the end of treatment was seen in 81.25% of patients in arm A compared with 90.48% of patients in arm B (P =.2028). BRFS was not significantly different between treatment arms. Diarrhea was the main nonhematologic toxicity. Long-term follow-up has not yet been enough to meet median PFS and OS. Conclusions: Concurrent weekly docetaxel can be administered safely with standard doses of RT without a significant increase in the toxicity profile. No statistically significant differences for 5-year BRFS, PFS, and OS have been observed when docetaxel was added to conventional treatment.
Original languageEnglish
Pages (from-to)344-352
JournalInternational Journal of Radiation Oncology Biology Physics
Volume103
DOIs
Publication statusPublished - 1 Feb 2019

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