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

NCT ID: NCT00003903

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-07-31

Study Completion Date

2007-08-31

Brief Summary

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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

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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.

Conditions

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Osteoporosis Prostate Cancer

Keywords

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stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer stage IV prostate cancer osteoporosis

Study Design

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Primary Study Purpose

SUPPORTIVE_CARE

Interventions

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management of therapy complications

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deepak M. Sahasrabudhe, MD

Role: STUDY_CHAIR

James P. Wilmot Cancer Center

Locations

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James P. Wilmot Cancer Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA011198

Identifier Type: NIH

Identifier Source: secondary_id

View Link

URCC-U2898

Identifier Type: -

Identifier Source: secondary_id

NCI-G99-1522

Identifier Type: -

Identifier Source: secondary_id

CDR0000067078

Identifier Type: -

Identifier Source: org_study_id