Clinical trial NCT00003903: Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer
Official title: An Evaluation of the Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Prostate Cancer
Keywords: stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer
osteoporosis
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 150
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center
state: New York
Study officials:
affiliation: James P. Wilmot Cancer Center
name: Deepak M. Sahasrabudhe, MD
role: STUDY_CHAIR
References: