RATIONALE: Calcitriol, a form of vitamin D, may be able to prevent or slow the growth of prostate cancer cells.

PURPOSE: Phase II trial to study the effectiveness of calcitriol in treating patients who have a rising PSA level following previous treatment for prostate cancer.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the prostate recurrent prostate cancer Quality of Life	Drug: calcitriol	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the response to pulse calcitriol in patients with previously treated adenocarcinoma of the prostate with rising PSA levels.

II. Assess the impact of this regimen on the slope of the PSA rise in these patients.

III. Determine the qualitative and quantitative toxic effects of this regimen in these patients.

IV. Assess the impact of this regimen on the quality of life in these patients.

PROTOCOL OUTLINE: All patients remain on a reduced calcium diet for the duration of the study. Twelve hours prior to treatment, patients begin drinking 4-6 glasses of extra fluid for 3 days.

Patients receive oral calcitriol over 4 hours weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 4 weeks during treatment, and at the end of the study.

Patients are followed for at least 1 month.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or cytologically proven adenocarcinoma of the prostate previously treated with prostatectomy or definitive radiotherapy
• Rising PSA after post definitive therapy nadir on at least 3 measurements at least 2 weeks apart; PSA at least 0.4 ng/mL for prostatectomy patients; PSA at least 1.0 ng/mL for radiotherapy patients

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior systemic chemotherapy for metastatic prostate cancer (except neoadjuvant treatment for localized prostate cancer)
• Endocrine therapy: No prior systemic hormonal therapy for prostate cancer (except neoadjuvant treatment for localized prostate cancer)
• Radiotherapy: See Disease Characteristics
• Surgery: See Disease Characteristics
• Other: No other concurrent systemic therapy for metastatic prostate cancer; At least 30 days since other prior investigational drugs; No concurrent digoxin; At least 7 days since prior thiazide diuretic therapy; No concurrent magnesium containing antacids, bile resin binding drugs, or calcium supplements

--Patient Characteristics--

• Age: 18 and over
• Performance status: ECOG 0-2
• Life expectancy: Greater than 2 months
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Phosphate no greater than 4.2 mg/dL; Creatinine no greater than 1.3 mg/dL; Calcium no greater than 10.5 mg/dL; No history of hypercalcemia
• Cardiovascular: No significant heart disease; No myocardial infarction within past 3 months; No history of heart failure; Cardiac ejection fraction at least 30%
• Other: No other significant active medical illness that would preclude compliance; Fertile patients must use effective contraception

Oregon
      Oregon Cancer Center at Oregon Health Sciences University, Portland,  Oregon,  97201-3098,  United States

Study chairs or principal investigators

William David Henner,  Study Chair,  Oregon Health and Science University   

Study ID Numbers:  CDR0000067041; OHSU-5231; NCI-V99-1542; OCC-HOR-98068-L
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  December 10, 1999
ClinicalTrials.gov Identifier:  NCT00004043
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08