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

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT00003903
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 150
• Location: 1
• Duration (Months): 97
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis; Prostate Cancer	Procedure: management of therapy complications	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Primary Purpose: Supportive Care
• Official Title: An Evaluation of the Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients
• Study Start Date: Jul 1, 1999
• Actual Primary Completion Date: Aug 1, 2007
• Actual Study Completion Date: Aug 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	James P. Wilmot Cancer Center	Rochester	New York	United States	14642-0001

Sponsors and Collaborators

• University of Rochester
• National Cancer Institute (NCI)

Investigators

• Study Chair: Deepak M. Sahasrabudhe, MD, James P. Wilmot Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Rochester
• ClinicalTrials.gov Identifier: NCT00003903
• Other Study ID Numbers: CDR0000067078; P30CA011198; URCC-U2898; NCI-G99-1522
• First Posted: Jan 27, 2003
• Last Update Posted: Oct 16, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by University of Rochester: stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer; osteoporosis
• Additional relevant MeSH terms: Prostatic Neoplasms; Osteoporosis

Study Results

No Results Posted as of Oct 16, 2013