PR.7 Companion Trial: Effect of Intermittent Versus Continuous Androgen Suppression on Bone Loss and Body Composition

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Ontario Cancer Research Network.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ontario Cancer Research Network
ClinicalTrials.gov Identifier:
NCT00228124
First received: September 27, 2005
Last updated: January 25, 2006
Last verified: September 2005
  Purpose

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.

Condition Phase
Prostate Cancer
Phase 3

Study Type: Observational
Study Design: Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Effect of Intermittent Versus Continuous Androgen Suppression on Bone Loss and Body Composition in a Phase III Randomized Trial

Resource links provided by NLM:


Further study details as provided by Ontario Cancer Research Network:

Estimated Enrollment: 300
Study Start Date: April 2004
Estimated Study Completion Date: April 2008
Detailed Description:

Primary Objectives:

  1. To compare CAS and IAS with respect to bone mineral density (BMD): We will determine whether the bone loss associated with long term CAS can be reduced by IAS by evaluation of:

    1. BMD,
    2. biochemical markers of bone formation/resorption,
    3. skeletal relevant events (SRE) (defined as pathological fracture, symptomatic hypercalcemia or hypocalcemia, spinal cord compression, or need of spinal orthosis for vertebral deformity or collapse).
  2. To compare CAS and IAS with respect to body composition: We will determine whether the reduction in muscle mass and increased fat accumulation associated with long term CAS can be reduced by IAS. We will evaluate:

    1. percentage fat body mass,
    2. percentage lean body mass and
    3. body mass index.
  3. To evaluate the predictive value of germline polymorphisms in the Vitamin D receptor (VDR) gene for bone loss

Eligible Patients for PR.7:

  1. Histologically confirmed prostate cancer (PCa)
  2. Completed radiotherapy to the prostatic area more than 12 months prior to randomization
  3. Rising prostate specific antigen (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)
  4. No definite evidence of distant metastasis (radiological changes compatible with non-malignant diseases are acceptable)
  5. 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

Evaluation during protocol treatment will take place to assess differences in BMD, body composition, biochemical and genetic markers of bone disease in the two groups.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00228124

Contacts
Contact: Laurence Klotz, MD, FRCSC 416-480-4673 laurence.klotz@sw.ca

Locations
Canada, Ontario
Sunnybrook and Women's College Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Marlene Kebabdjian, CRA    416-480-6100 ext 2890    marlene.kebabdjian@sw.ca   
Sponsors and Collaborators
Ontario Cancer Research Network
Investigators
Principal Investigator: Laurence Klotz, MD, FRCSC Sunnybrook Health Sciences Centre
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00228124     History of Changes
Other Study ID Numbers: 02-OCT-0203, 02-OCT-0203
Study First Received: September 27, 2005
Last Updated: January 25, 2006
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ontario Cancer Research Network:
Prostate cancer
Continuous androgen suppression
Intermittent androgen suppression
Bone loss
Osteoporosis

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 August 28, 2014