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


Phase 3
18 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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

- Zubrod 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. AST, ALT > 1.5 times the
upper normal limit.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Specific survival

Principal Investigator

Abdenour Nabid, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre de Recherche Clinique √Čtienne LeBel/CHUS Fleurimont

Authority:

Canada: Health Canada

Study ID:

PCS IV

NCT ID:

NCT00223171

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Stage T3 T4
  • PSA > 20
  • Gleason Score > 7
  • Prostatic Neoplasms

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