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Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance
Not Recruiting
Trial ID: NCT00482157
Purpose
After the diagnosis of prostate cancer, many men alter their lifestyle or diet or use various
supplements in an attempt to retard the growth of their cancer. While there is limited data
on the use of diet and supplements to alter the risk of prostate cancer, even less is known
regarding the ability of diet or supplements to alter progression. For men who have elected
active surveillance, the investigators propose to investigate the ability of vitamin D to
retard the growth of prostate cancer.
Official Title
Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
Eligibility
Inclusion Criteria:- Untreated prostate adenocarcinoma by an extended biopsy (>8 needle
cores on systematic prostate biopsy) within 1 year of the screening date
- PSA <10.0 ng/ml
- Gleason sum 6 or <2 mm Gleason pattern 4
- No more than 33% of biopsy cores positive Exclusion Criteria:- Prior or concurrent
treatment for prostate cancer
- Use of Finasteride, Dutasteride, Saw Palmetto
- Use of NSAIDs, COX-2 inhibitors and/or aspirin, soy or vitamin D supplements for more
than 7 days over the one month prior to study
- Kidney disease, hypercalcemia or renal stones
- ECOG performance status >1
- Uncontrolled hypertension, unstable angina, history of transient ischemic attack
(TIA), history of stroke.
Intervention(s):
drug: Vitamin D (Calcitriol)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office CCTO
6504987061