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Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance

45 Years
Open (Enrolling)
Prostatic Neoplasms

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Trial Information

Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance

Men will be randomized to each of two arms for a total of 24 subjects: calcitriol alone
(DN101, 45 micrograms once weekly) or placebo. Baseline laboratory assays, including serum
PSA, serum and urine calcium and creatinine, will be performed and the EPIC questionnaire
(expanded prostate cancer index composite, validated HRQOL tool for prostate cancer
patients) will be completed. Patients will also undergo prostate needle biopsy [4 cores
taken under transrectal ultrasound (TRUS) guidance] to establish baseline levels of gene
expression. Follow-up at the end of 2 weeks (just prior to the third dose) will include a
history and physical, and a repeat of all baseline blood and urine tests. Follow-up at 3
months will include a history and physical, repeating all blood and urine tests, and the
EPIC questionnaire. At 6 months, in addition to the history and physical, blood and urine
tests, and the EPIC questionnaire, a TRUS-guided prostate needle biopsy will be performed.
This will be a standard 12-core scheme and 4 of these cores will be used for laboratory
analysis. Renal ultrasounds will again be performed on men in the calcitriol arms to look
for stones. Patients who show no evidence of clinical progression will be offered to remain
on study, in their designated treatment arm, for an additional 6 months. Any patient
exhibiting clinical progression at any time will be withdrawn from the study and offered
standard treatment options. For patients remaining on study at 12 months, an end-of-study
biopsy will be requested (12-core scheme with 4 cores used for laboratory analysis)

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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

PSA velocity > than 2 ng/ml/year; any adverse pathological findings on extended pattern biopsies with a Gleason sum >7; involvement of > 50% of any core by cancer; > 1/3 of cores positive; or other incidental evidence of clinical progression

Principal Investigator

Joseph C. Presti Jr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

February 2007

Completion Date:

November 2008

Related Keywords:

  • Prostatic Neoplasms
  • Neoplasms
  • Prostatic Neoplasms



Stanford University School of Medicine Stanford, California  94305-5317