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

Prostate Cancer Clinical Trial

— PCS III  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00223145
• Other study ID #: DC-990-0049,1
• Secondary ID: DC-990-0049
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: December 2000
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2022
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• Radiotherapy 70 Gy
Radiotherapy to the prostate
• Radiotherapy 76 Gy
Radiotherapy to the prostate

Drug:
• Androgen blockade
Duration : 6 months

Locations

Country	Name	City	State
Canada	Centre de Recherche Clinique du CHUS	Sherbrooke	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Abdenour Nabid	AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interval before biochemical failure		10 years
Secondary	Toxicity of irradiation		10 years
Secondary	Survival		10 years