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

NCT00228124 | Unknown

• 1 other identifier: 02-OCT-0203
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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. 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. 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

Keywords

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

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Severe osteoporosis

Sponsors & Collaborators

• Ontario Cancer Research Network: lead

Study Sites (1)

Sunnybrook and Women's College Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Bone Diseases, Metabolic; Osteoporosis

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Laurence Klotz, MD, FRCSC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurence Klotz, MD, FRCSC

CONTACT

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

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: September 27, 2005
• First Posted: September 28, 2005
• Study Start: April 1, 2004
• Study Completion: April 1, 2008
• Last Updated: January 26, 2006

Record last verified: 2005-09

Locations

CA (1)