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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:
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

November 1, 1999
October 14, 2013
July 1999
August 2007   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00003903 on ClinicalTrials.gov Archive Site
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Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer
An Evaluation of the Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients

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.

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.

Interventional
Not Provided
Primary Purpose: Supportive Care
  • Osteoporosis
  • Prostate Cancer
Procedure: management of therapy complications
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003903
CDR0000067078, P30CA011198, URCC-U2898, NCI-G99-1522
Not Provided
University of Rochester
University of Rochester
National Cancer Institute (NCI)
Study Chair: Deepak M. Sahasrabudhe, MD James P. Wilmot Cancer Center
University of Rochester
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP