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

This study is ongoing, but not recruiting participants.

First Received: November 1, 1999 Last Updated: May 9, 2009 History of Changes

Sponsor:	James P. Wilmot Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003903

Purpose

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.

Condition	Intervention
Osteoporosis Prostate Cancer	Procedure: management of therapy complications

Study Type:	Interventional
Study Design:	Supportive Care
Official Title:	An Evaluation of the Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Osteoporosis Prostate Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	150
Study Start Date:	July 1999

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.

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003903

Locations

United States, New York
James P. Wilmot Cancer Center
Rochester, New York, United States, 14642-0001

Sponsors and Collaborators

James P. Wilmot Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Deepak M. Sahasrabudhe, MD

James P. Wilmot Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067078, URCC-U2898, NCI-G99-1522
Study First Received:	November 1, 1999
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00003903 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
osteoporosis

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Osteoporosis
Bone Diseases, Metabolic
Urogenital Neoplasms
Genital Diseases, Male

Bone Diseases
Hormones
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Musculoskeletal Diseases
Prostatic Neoplasms
Androgens

ClinicalTrials.gov processed this record on November 05, 2009