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

Prostate Cancer Clinical Trial

Official title:

An Evaluation of the Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003903
• Other study ID #: CDR0000067078
• Secondary ID: P30CA011198URCC-
• Status: Completed
• Phase: N/A
• First received: November 1, 1999
• Last updated: October 14, 2013
• Start date: July 1999
• Est. completion date: August 2007

Study information

• Verified date: October 2013
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Osteoporosis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• management of therapy complications

Locations

Country	Name	City	State
United States	James P. Wilmot Cancer Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,