NCT00651326

Androgen Suppression and Radiation With/Out Docetaxel in High-Risk Localized Prostate Cancer

A Phase III Study of Neoadjuvant Docetaxel and Androgen Suppression Plus Radiation Therapy Versus Androgen Suppression Alone Plus Radiation Therapy for High-Risk Localized Adenocarcinoma of the Prostate

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, leuprolide, buserelin, and goserelin, may lessen the amount of androgens made by the body. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving androgen suppression therapy together with radiation therapy is more effective with or without docetaxel in treating prostate cancer. PURPOSE: This randomized phase III trial is studying androgen suppression therapy, radiation therapy, and docetaxel to see how well they work compared with androgen suppression therapy and radiation therapy in treating patients with high-risk localized prostate cancer. CLOSURE: This trial closed to further accrual in November 2009. The study endpoints will not be reached.

Detailed description

OBJECTIVES: Primary * To compare disease-free survival rates in patients with high-risk localized adenocarcinoma of the prostate treated with androgen suppression therapy and radiotherapy with vs without docetaxel. Secondary * To compare overall survival. * To compare time to biochemical disease progression. * To compare time to local disease progression. * To compare time to distant disease progression. * To compare time to next anticancer therapy. * To compare progression-free survival. * To compare degree of prostate-specific antigen (PSA) suppression prior to radiotherapy. * To compare quality of life (QOL) using EORTC QLQ C30 and EORTC QLQ PR25 questionnaires and a trial-specific checklist. * To compare the nature, severity, and frequency of adverse events. OUTLINE: This is a multicenter study. Patients are stratified according to Gleason score (≤ 7 vs ≥ 8), baseline prostate-specific antigen (PSA) (\> 20 ng/mL vs ≤ 20 ng/mL), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive androgen suppression therapy comprising oral flutamide three times daily or oral bicalutamide once daily for 4 weeks AND leuprolide subcutaneously (SC) or intramuscularly every 1-6 months, buserelin SC every 2 or 3 months, or goserelin SC every 1 or 3 months for 3 years. Patients also receive docetaxel IV over 60 minutes on day 1. Treatment with docetaxel repeats every 21 days for up to 4 courses. Beginning at least 4 weeks after completion of chemotherapy, patients undergo pelvic radiotherapy once daily 5 days a week for up to 8 weeks. * Arm II: Patients receive androgen suppression therapy and undergo pelvic radiotherapy as in arm I. Patients complete quality of life questionnaires at baseline, periodically during treatment, and then every 6 months for 5 years. After completion of study treatment, patients are followed at 3 and 6 months, every 6 months for 5 years, and then annually thereafter.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	bicalutamide
DRUG	buserelin
DRUG	flutamide
DRUG	goserelin
DRUG	leuprolide acetate
PROCEDURE	neoadjuvant therapy
PROCEDURE	quality-of-life assessment
RADIATION	radiation therapy	46 Gy in 23 fractions over \< 5 weeks. Boost: 24-28 Gy in 12-14 fractions over \< 3 weeks
DRUG	Docetaxel

Timeline

• Start date: 2008-06-02
• Primary completion: 2010-05-14
• Completion: 2011-01-18
• First posted: 2008-04-02
• Last updated: 2023-08-04

Locations

13 sites across 1 country: Canada