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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00003903
First received: November 1, 1999
Last updated: October 14, 2013
Last verified: October 2013
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Rochester
Investigators
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
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 August 21, 2014