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

University of Rochester

Status: Completed

Conditions: Osteoporosis; Prostate Cancer

Treatments: Procedure: management of therapy complications

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00003903

P30CA011198 (U.S. NIH Grant/Contract)

URCC-U2898

NCI-G99-1522

CDR0000067078

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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