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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
First received: November 1, 1999
Last updated: October 14, 2013
Last verified: October 2013

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
Prostate Cancer
Procedure: management of therapy complications

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

Resource links provided by NLM:

Further study details as provided by University of Rochester:

Estimated Enrollment: 150
Study Start Date: July 1999
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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



  • Not specified

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Calcium normal


  • Not specified


  • Not specified


Biologic therapy:

  • Not specified


  • See Disease Characteristics

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent high dose steroids


  • Prior radiotherapy allowed


  • See Disease Characteristics
  • Prior radical prostatectomy allowed


  • No concurrent bisphosphonates
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00003903

United States, New York
James P. Wilmot Cancer Center
Rochester, New York, United States, 14642-0001
Sponsors and Collaborators
University of Rochester
National Cancer Institute (NCI)
Study Chair: Deepak M. Sahasrabudhe, MD James P. Wilmot Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00003903     History of Changes
Other Study ID Numbers: CDR0000067078, P30CA011198, URCC-U2898, NCI-G99-1522
Study First Received: November 1, 1999
Last Updated: October 14, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Bone Diseases
Bone Diseases, Metabolic
Genital Diseases, Male
Genital Neoplasms, Male
Musculoskeletal Diseases
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on December 01, 2015