Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance

Not Recruiting

Trial ID: NCT00482157


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
Sandy Srinivas

Professor of Medicine (Oncology) and, by courtesy, of Urology


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.


drug: Vitamin D (Calcitriol)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office CCTO

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