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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003903
First received: November 1, 1999
Last updated: February 18, 2011
Last verified: September 2003
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 150
Study Start Date: July 1999
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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003903

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00003903     History of Changes
Other Study ID Numbers: CDR0000067078, URCC-U2898, NCI-G99-1522
Study First Received: November 1, 1999
Last Updated: February 18, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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:
Osteoporosis
Prostatic Neoplasms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013