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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Abdenour Nabid, Centre Hospitalier Universitaire de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00223171
First received: September 13, 2005
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Androgen blockade + radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Multicentre, Phase III Study: Assessment of the Duration of Androgen Blockade Combined With Pelvic Irradiation in High-risk Prostate Cancers

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Specific survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Treatment morbidity induced versus quality of life based on duration of hormonal therapy [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Site of tumour relapse [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Interval until first biochemical failure [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Interval until second biochemical failure during salvage androgen suppression (hormone-resistant tumour) [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: October 2000
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00223171

Locations
Canada, Quebec
Centre de Recherche Clinique du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
AstraZeneca
Investigators
Principal Investigator: Abdenour Nabid, MD Centre de Recherche Clinique Étienne LeBel/CHUS Fleurimont
  More Information

No publications provided

Responsible Party: Abdenour Nabid, Principal Investigator, Centre Hospitalier Universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT00223171     History of Changes
Other Study ID Numbers: DC-990-0056,1, DC-990-0056
Study First Received: September 13, 2005
Last Updated: July 18, 2013
Health Authority: Canada: Health Canada

Keywords provided by Université de Sherbrooke:
Stage T3 T4
PSA > 20
Gleason Score > 7

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014