Calcitriol and Dexamethasone in Treating Patients With Prostate Cancer Who Have Undergone Surgery or Radiation Therapy
- Conditions
- Prostate Cancer
- Registration Number
- NCT00054522
- Lead Sponsor
- Roswell Park Cancer Institute
- Brief Summary
RATIONALE: Calcitriol may help tumor cells develop into normal cells. Dexamethasone may increase the effectiveness of calcitriol by making tumor cells more sensitive to the drug.
PURPOSE: Phase II trial to study the effectiveness of combining calcitriol with dexamethasone in treating patients with prostate cancer who have undergone surgery or radiation therapy.
- Detailed Description
OBJECTIVES:
* Determine whether calcitriol and dexamethasone can slow the rise in prostate-specific antigen (PSA) levels in patients with early, recurrent prostate cancer after prior radical prostatectomy or radiotherapy.
* Determine the safety of this regimen in these patients.
* Determine the utility of serum PSA in monitoring the therapeutic effect of calcitriol in these patients.
OUTLINE: Patients are stratified according to prior therapy (radical prostatectomy vs radiotherapy).
Patients receive oral calcitriol once daily on days 1-3 alone on week 1. Beginning on week 3, patients receive calcitriol as in week 1 and oral dexamethasone on days 0-4. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 56 patients (28 per stratum) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States