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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003903
First Posted: January 27, 2003
Last Update Posted: October 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Rochester
  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: 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:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003903


Locations
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)
Investigators
Study Chair: Deepak M. Sahasrabudhe, MD James P. Wilmot Cancer Center
  More Information

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00003903     History of Changes
Other Study ID Numbers: CDR0000067078
P30CA011198 ( U.S. NIH Grant/Contract )
URCC-U2898
NCI-G99-1522
First Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: October 16, 2013
Last Verified: October 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
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs