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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

May 9, 2009

Start Date ^ICMJE

July 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00003903 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care

Condition ^ICMJE

Osteoporosis
Prostate Cancer

Intervention ^ICMJE

Procedure: management of therapy complications

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

150

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00003903

Responsible Party

Study ID Numbers ^ICMJE

CDR0000067078, URCC-U2898, NCI-G99-1522

Study Sponsor ^ICMJE

James P. Wilmot Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Deepak M. Sahasrabudhe, MD

James P. Wilmot Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

September 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP