Duration of Androgen Blockade Combined With Pelvic Irradiation in Prostate Cancers (PCS IV)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Androgen blockade + radiation therapy

• Study Type: Interventional
• Enrollment (Actual): 630
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre de recherche clinique du CHUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1 : 36 months AB + RT; 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; Androgen blockade + radiation therapy
Experimental: Arm 2 : 18 months AB + RT; 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; Androgen blockade + radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Université de Sherbrooke
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Abdenour Nabid, MD, Centre de Recherche Clinique Étienne LeBel/CHUS Fleurimont

Study record dates

Study Major Dates

• Study Start: October 1, 2000
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 22, 2005

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Stage T3 T4; PSA > 20; Gleason Score > 7
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens
• Other Study ID Numbers: DC-990-0056,1; DC-990-0056

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No