PCS III: Study on the Role of Hormonal Treatment for Two Dosage Levels of Prostate Radiation Therapy Versus Prostate Radiation Therapy Alone

Sponsor

Abdenour Nabid (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00223145

Collaborator

AstraZeneca (Industry)

600

Enrollment

Location

Arms

277

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The hypothesis of the proposed study would be that, due to the six months of total androgen blockade, which would include neoadjuvant hormonal therapy for four months and concomitant hormonal therapy for two months with irradiation, the investigators could reduce local failure rates for these two dosage levels, namely 70 Gy and 76 Gy. Since increasing the dose to the prostate also seems to reduce local relapse rates, the results of the two hormonal therapy groups would be compared with the results of prostate irradiation at doses of 76 Gy. This study would verify the possibility of compensating a six Gy dosage increase of radiation therapy with six months of hormonal therapy between the 70 Gy and 76 Gy groups who received hormonal therapy, and also match these results with a dose escalation to the prostate of 76 Gy. In the future, this could result in more therapeutic choices, such as reducing the doses of radiation therapy and, consequently, its related complications, if hormonal therapy proves to be beneficial; or rather, to continue in the direction of dose escalation for this intermediate-risk patient group, everything being correlated to the side effects of hormonal therapy and irradiation.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Radiation: Radiotherapy 70 Gy Radiation: Radiotherapy 76 Gy Drug: Androgen blockade	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized, Multicentre, Phase III Study in Patients With Intermediate-risk T1 T2 Prostate Adenocarcinomas, to Verify the Role of Six Months of Total Androgen Blockade for Two Dosage Levels of Prostate Radiation Therapy (70 Gy and 76 Gy) Versus Prostate Radiation Therapy Alone at 76 Gy

Study Start Date :

Dec 1, 2000

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Androgen blockade for 6 months + Radiotherapy 70 Gy	Radiation: Radiotherapy 70 Gy Radiotherapy to the prostate Drug: Androgen blockade Duration : 6 months Other Names: Bicalutamide 50 mg Goserelin 10.8 mg
Experimental: Arm 2 Androgen blockade for 6 months + Radiotherapy 76 Gy	Radiation: Radiotherapy 76 Gy Radiotherapy to the prostate Drug: Androgen blockade Duration : 6 months Other Names: Bicalutamide 50 mg Goserelin 10.8 mg
Active Comparator: Arm 3 Radiotherapy alone with 76 Gy	Radiation: Radiotherapy 76 Gy Radiotherapy to the prostate

Arm

Intervention/Treatment

Experimental: Arm 1

Androgen blockade for 6 months + Radiotherapy 70 Gy

Radiation: Radiotherapy 70 Gy

Radiotherapy to the prostate

Drug: Androgen blockade

Duration : 6 months

Other Names:

Bicalutamide 50 mg

Goserelin 10.8 mg

Experimental: Arm 2

Androgen blockade for 6 months + Radiotherapy 76 Gy

Radiation: Radiotherapy 76 Gy

Radiotherapy to the prostate

Drug: Androgen blockade

Duration : 6 months

Other Names:

Bicalutamide 50 mg

Goserelin 10.8 mg

Active Comparator: Arm 3

Radiotherapy alone with 76 Gy

Radiation: Radiotherapy 76 Gy

Radiotherapy to the prostate

Outcome Measures

Primary Outcome Measures

Interval before biochemical failure [10 years]

Secondary Outcome Measures

Toxicity of irradiation [10 years]
Survival [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is less than or equal to 6, as well as a prostate-specific antigen (PSA) between 10-20 (intermediate risk) or patients with stage T1 or T2 untreated adenocarcinoma of the prostate, with a Gleason score that is equal to 7, as well as a PSA equal to or less than 20 (intermediate risk).
Performance status score of 0-1
Patients must sign a consent form before starting the study.
No evidence of regional disease
Patients with a previous history of cancer are eligible on the condition that they have been disease-free for more than five years.
Non-invasive epidermoid cancers of the skin are eligible.
The patient must be available for treatments and follow-up visits.
No evidence of metastatic disease, confirmed by a negative bone scan.

Exclusion Criteria:

Severe medical or psychiatric problems that may compromise study compliance
Chronic hepatic disease; abnormal hepatic function, i.e. aspartate aminotransferase and alanine aminotransferase > 1.5 times the upper normal limit.