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

Primary Purpose

Osteoporosis, Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
management of therapy complications
Sponsored by
University of Rochester
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoporosis focused on measuring stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer, osteoporosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • James P. Wilmot Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
October 14, 2013
Sponsor
University of Rochester
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003903
Brief Title
Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer
Official Title
An Evaluation of the Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Rochester
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Evaluate the effect of androgen ablation on bone resorption in patients with or without bone metastases secondary to prostate cancer. OUTLINE: Patients are stratified according to prior androgen ablation therapy (yes vs no) and metastatic disease (yes vs no). Patients undergo blood work and 24 hour urine collection on day 1 and at week 6-8. Patients who have received androgen ablation therapy and are found to have increased bone resorption undergo a dual energy x-ray absorptiometry (DEXA) scan. A comparison is made between androgen ablation therapy and bone resorption and if metastases are associated with the two. PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 9 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
management of therapy complications

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepak M. Sahasrabudhe, MD
Organizational Affiliation
James P. Wilmot Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
James P. Wilmot Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-0001
Country
United States

12. IPD Sharing Statement

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

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