Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment androgen blockade + radiation therapy
Phase phase 3
Sponsor Université de Sherbrooke
Collaborator AstraZeneca
Start date October 2000
End date January 2016
Trial size 650 participants
Trial identifier NCT00223171, DC-990-0056, DC-990-0056,1

Summary

The objective of this study is to use as a reference the 36-month duration of hormonal therapy according to the European Organization for Research of the Treatment of Cancer (EORTC protocol 22863) : namely one-month of total androgen blockade followed by a luteinizing hormone releasing hormone (LHRH) agonist, all for three years, combined with pelvic and prostate irradiation; this arm is currently considered to be a standard for high-risk prostate cancers. The proposed study intends to challenge the duration of hormonal therapy and verify whether the five-year outcomes in favour of combined treatment in regard to survival (79% versus 62%) and local control (85% versus 48%) can be transposed for hormonal therapy that is half as long, namely 18 months, with the possibility of hormone salvage therapy in the event of biochemical and/or clinical failure (local, regional, or distant); this applies to both arms. The proposed study will compare survival in the two groups and evaluate in each one the total duration of initial hormonal therapy, followed by initial hormonal therapy combined with salvage hormonal therapy, the duration of salvage hormonal therapy until hormonal therapy resistance, and the side effects of this hormonal therapy, with everything being related to an assessment of the quality of life of these patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Androgen blockade : 36 months of androgen blockade : bicalutamide 50 mg die for one month, goserelin 10.8 mg x 12 Q 3 months + radiation therapy : pelvis 44 grays , prostate 70 grays (2 grays/fraction)
androgen blockade + radiation therapy
Androgen blockade + radiation therapy
(Experimental)
Androgen blockade 18 months : bicalutamide 50 mg die for one month, goserelin 10.8 mg x 6 Q 3 months + radiation therapy ( pelvis 44 grays , prostate 70 grays ,2 grays/fraction)
androgen blockade + radiation therapy
Androgen blockade + radiation therapy

Primary Outcomes

Measure
Specific survival
time frame: 10 years
Overall survival
time frame: 10 years
Treatment morbidity induced versus quality of life based on duration of hormonal therapy
time frame: 10 years

Secondary Outcomes

Measure
Disease-free survival
time frame: 10 years
Site of tumour relapse
time frame: 10 years
Interval until first biochemical failure
time frame: 10 years
Interval until second biochemical failure during salvage androgen suppression (hormone-resistant tumour)
time frame: 10 years

Eligibility Criteria

Male participants from 18 years up to 80 years old.

Inclusion Criteria: - To have at least one of the following three risk factors: - Tumour classified T3 or T4 - Gleason score 8-10 - Prostate-specific antigen (PSA) level > 20 - Performance status score of 0-1. - Patients must sign a consent form before the start of the study. - No evidence of regional disease: clinically negative regional adenopathies are revealed by imaging (computed axial tomography [CAT] scan, magnetic resonance imaging [MRI], lymphography) or surgical staging or negative pelvic node dissection. - No distant metastasis. These patients must all have a negative bone scan 12 weeks prior to randomization. - Hormonal therapy is allowed up to a maximum of two months before the consent form is signed, as long as the initial work-up was done, including having the requested deadlines respected. - Patients with a previous history of cancer are eligible on the condition that they have not had any disease progression for more than five years. - The patient must be available for treatments and follow-up visits. - Treatments must start in the three weeks following randomization. Exclusion Criteria: - Severe medical or psychiatric problems that could compromise study compliance. - Chronic hepatic disease, abnormal hepatic functions, i.e. aspartate aminotransferase, alanine aminotransferase > 1.5 times the upper normal limit.

Additional Information

Official title Randomized, Multicentre, Phase III Study: Assessment of the Duration of Androgen Blockade Combined With Pelvic Irradiation in High-risk Prostate Cancers
Principal investigator Abdenour Nabid, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Université de Sherbrooke.