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NCT Number: NCT00223171

Duration of Androgen Blockade Combined With Pelvic Irradiation in 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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Centre de Recherche Clinique du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Androgen blockade + radiation therapy

Drug

Androgen blockade + radiation therapy

Primary outcomes

  1. Specific survival

    Time frame: 10 years

  2. Overall survival

    Time frame: 10 years

  3. Treatment morbidity induced versus quality of life based on duration of hormonal therapy

    Time frame: 10 years

Secondary outcomes

  1. Disease-free survival

    Time frame: 10 years

  2. Site of tumour relapse

    Time frame: 10 years

  3. Interval until first biochemical failure

    Time frame: 10 years

  4. Interval until second biochemical failure during salvage androgen suppression (hormone-resistant tumour)

    Time frame: 10 years

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Acronym: PCS IV

Important dates

Study start
2000
Primary completion
2026
Study completion
2027
First posted
Sep 22, 2005
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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