Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer

NCT00003903 | Completed

• 4 other identifiers: CDR0000067078P30CA011198URCC-U2898NCI-G99-1522
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Assessing the effect of androgen suppression on bone loss in prostate cancer patients may improve the ability to plan treatment, may decrease the risk of fractures and bony pain, and may help patients live more comfortably. PURPOSE: Clinical trial to determine the effect of androgen suppression on bone loss in patients who have prostate cancer.

Conditions

Osteoporosis; Prostate Cancer

Keywords

stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer; osteoporosis

Interventions

management of therapy complications PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer * Stratum 1 (androgen ablation therapy): * Bone metastases * Prior orchiectomy allowed * Prior or concurrent leuprolide and/or goserelin therapy allowed * Stratum 2 (androgen ablation therapy): * No bone metastases * Prior orchiectomy allowed * Prior or concurrent leuprolide and/or goserelin therapy allowed * Stratum 3 (no androgen ablation therapy): * No metastatic disease * Prior flutamide or bicalutamide therapy allowed PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Calcium normal Hepatic: * Not specified Renal: * Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * See Disease Characteristics * No concurrent high dose steroids Radiotherapy: * Prior radiotherapy allowed Surgery: * See Disease Characteristics * Prior radical prostatectomy allowed Other: * No concurrent bisphosphonates

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

James P. Wilmot Cancer Center

Rochester, New York, 14642-0001, United States

Location

MeSH Terms

Conditions

Osteoporosis; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Deepak M. Sahasrabudhe, MD

  James P. Wilmot Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: July 1, 1999
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

US (1)