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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004043
Recruitment Status : Completed
First Posted : June 17, 2004
Last Update Posted : April 28, 2017
Information provided by (Responsible Party):
Tom Beer, OHSU Knight Cancer Institute

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: calcitriol Phase 2

Detailed Description:

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.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Pulse Calcitriol in Patients With Rising PSA After Definitive Treatment for Prostate Cancer
Study Start Date : February 1999
Actual Primary Completion Date : March 2003
Actual Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Calcitriol

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004043

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United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
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Study Chair: Tomasz Beer, MD OHSU Knight Cancer Institute

Publications of Results:
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.

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Responsible Party: Tom Beer, Principal Investigator, OHSU Knight Cancer Institute Identifier: NCT00004043     History of Changes
Other Study ID Numbers: CDR0000067041
First Posted: June 17, 2004    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Keywords provided by Tom Beer, OHSU Knight Cancer Institute:
adenocarcinoma of the prostate
recurrent prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Growth Substances
Bone Density Conservation Agents