Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Calcitriol in Treating Patients With a Rising PSA Level Following Treatment for Prostate Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over Other OHSU-5231 OCC-HOR-98068-L, NCI-V99-1542, NCT00004043

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 of these patients.

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

Expected Enrollment

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

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.

Lowe BA, Henner WD, Lemmon DD, et al.: Long term administration of high dose weekly oral calcitriol in patients with a rising PSA after definitive treatment for prostate cancer (PC): a phase II study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2446, 2002.

Trial Contact Information

Trial Lead Organizations

Oregon Health and Science University Cancer Institute

William Henner, MD, PhD, Protocol chair(Contact information may not be current)		Ph: 503-494-1617; 800-494-1234

Registry Information
Official Title		Phase II Study of Pulse Calcitriol in Patients with Rising PSA After Definitive Treatment for Prostate Cancer
Trial Start Date		1999-02-15
Registered in ClinicalTrials.gov		NCT00004043
Date Submitted to PDQ		1999-04-26
Information Last Verified		2000-11-01

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