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An Evaluation of the Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients


N/A
N/A
N/A
Open (Enrolling)
Male
Osteoporosis, Prostate Cancer

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Trial Information

An Evaluation of the Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Deepak M. Sahasrabudhe, MD

Investigator Role:

Study Chair

Investigator Affiliation:

James P. Wilmot Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067078

NCT ID:

NCT00003903

Start Date:

July 1999

Completion Date:

Related Keywords:

  • Osteoporosis
  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • osteoporosis
  • Osteoporosis
  • Prostatic Neoplasms

Name

Location

James P. Wilmot Cancer CenterRochester, New York  14642