Recruiting

Androgen Suppression

Sponsor:

Ontario Cancer Research Network

Code:

NCT00228124

Conditions

Prostate Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this study is to determine, in patients entered on the National Cancer Institute of Canada (NCIC)-PR.7 trial of intermittent versus continuous androgen ablation, whether the rates of osteoporosis, fractures, and alteration in body composition are reduced by intermittent androgen ablation.

There will be two groups of patients:

1. A cross-sectional group of 150 patients registered in PR.7 prior to January 1, 2002, randomized between intermittent androgen suppression (IAS) and continuous androgen suppression (CAS) (75 from each group). Patients who have definite bone metastases are excluded from this study. Biochemical failure does not exclude the patient.
2. A longitudinal study of 150 newly accrued patients randomized between IAS and CAS (75 from each group). These patients will have baseline evaluation of bone loss and body composition, longitudinal monitoring and follow-up on an annual basis for patients on CAS and at the end of each "off cycle" of IAS. Patients taking bisphosphonates are excluded from this study.

Conditions

Prostate Cancer

Study ID

NCT00228124

Start date

Apr, 2004

Status verified date

Sep, 2005

Completion date

Apr, 2008

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Histologically confirmed PCa
  • Completed radiotherapy to the prostatic area more than 12 months prior to randomization
  • Rising PSA level (serum PSA > 3 ng/ml (3 μg/L)) and higher than the lowest level recorded previously since the end of radiotherapy (i.e. higher than the post-radiotherapy nadir)
  • No definite evidence of distant metastasis (radiological changes compatible with non-malignant diseases are acceptable)
  • No prior hormonal therapy with the exception of neo-adjuvant cytoreduction prior to radical radiotherapy or prostatectomy for a maximum duration of 12 months and completed at least 12 months prior to randomization.

Exclusion Criteria:

  • Severe osteoporosis

Study Design

Enrollment

300 participants

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Laurence Klotz, MD, FRCSC

416-480-4673laurence.klotz@sw.ca

Locations

Sunnybrook and Women's College Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Marlene Kebabdjian, CRA

416-480-6100marlene.kebabdjian@sw.ca

More Information

Sponsor

Ontario Cancer Research Network

Last update posted

Jan 26, 2006

Last verified

Sep, 2005

Keywords

  • Prostate cancer
  • Continuous androgen suppression
  • Intermittent androgen suppression
  • Bone loss
  • Osteoporosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ontario Cancer Research Network on 2006-01-26.