Duration of Androgen Blockade Combined With Pelvic Irradiation in Prostate Cancers

Prostate Cancer Clinical Trial

— PCS IV  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00223171
• Other study ID #: DC-990-0056,1
• Secondary ID: DC-990-0056
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 630
• 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:

• 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Androgen blockade + radiation therapy
Androgen blockade + radiation therapy

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific survival		10 years
Primary	Overall survival		10 years
Primary	Treatment morbidity induced versus quality of life based on duration of hormonal therapy		10 years
Secondary	Disease-free survival		10 years
Secondary	Site of tumour relapse		10 years
Secondary	Interval until first biochemical failure		10 years
Secondary	Interval until second biochemical failure during salvage androgen suppression (hormone-resistant tumour)		10 years