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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00223171
Recruitment Status : Active, not recruiting
First Posted : September 22, 2005
Last Update Posted : May 26, 2022
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Abdenour Nabid, Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Androgen blockade + radiation therapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2000
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00223171


Locations
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Canada, Quebec
Centre de Recherche Clinique du CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Sponsors and Collaborators
Université de Sherbrooke
AstraZeneca
Investigators
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Principal Investigator: Abdenour Nabid, MD Centre de Recherche Clinique Étienne LeBel/CHUS Fleurimont
More Information
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Responsible Party: Abdenour Nabid, Principal Investigator, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
ClinicalTrials.gov Identifier: NCT00223171    
Other Study ID Numbers: DC-990-0056,1
DC-990-0056
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: May 26, 2022
Last Verified: May 2022
Keywords provided by Abdenour Nabid, Centre de recherche du Centre hospitalier universitaire de Sherbrooke:
Stage T3 T4
PSA > 20
Gleason Score > 7
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
 Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs