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


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Biopsy of the Prostate


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

This study is no longer recruiting patients.

Sponsors and Collaborators: James P. Wilmot Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer
Osteoporosis
 Procedure: complications of therapy assessment/management
 Procedure: supportive care/therapy

MedlinePlus related topics:  Osteoporosis;   Prostate Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Study of Androgen Ablation and Bone Resorption in Patients With or Without Bone Metastases Secondary to Prostate Cancer

Further Study Details: 

OBJECTIVES:

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:  Both

Criteria

DISEASE CHARACTERISTICS:

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:

Surgery:

Other:

  • No concurrent bisphosphonates

Location Information


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

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067078; URCC-U2898; NCI-G99-1522
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003903
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 7, 2008



Page Updated: September 6, 2005
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