Duration of Androgen Blockade Combined With Pelvic Irradiation in Prostate Cancers

Study Overview
=================
Brief 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.

Official Title
-----------------
Randomized, Multicentre, Phase III Study: Assessment of the Duration of Androgen Blockade Combined With Pelvic Irradiation in High-risk Prostate Cancers

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Androgen blockade + radiation therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1 : 36 months AB + RT<br>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) | Drug: Androgen blockade + radiation therapy<br>* Androgen blockade + radiation therapy<br>|
| Experimental: Arm 2 : 18 months AB + RT<br>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) | Drug: Androgen blockade + radiation therapy<br>* Androgen blockade + radiation therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific survival |  | 10 years | 
| Overall survival |  | 10 years | 
| Treatment morbidity induced versus quality of life based on duration of hormonal therapy |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival |  | 10 years | 
| Site of tumour relapse |  | 10 years | 
| Interval until first biochemical failure |  | 10 years | 
| Interval until second biochemical failure during salvage androgen suppression (hormone-resistant tumour) |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stage T3 T4, PSA > 20, Gleason Score > 7