Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00482157
First received: May 31, 2007
Last updated: June 23, 2009
Last verified: June 2009
  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.


Condition Intervention
Prostatic Neoplasms
Drug: Vitamin D (Calcitriol)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 24
Study Start Date: February 2007
Estimated Study Completion Date: November 2008
Estimated Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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)

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00482157

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Joseph C. Presti Jr. Stanford University
  More Information

No publications provided

Responsible Party: Joseph C. Presti Jr., Principal Investigator, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00482157     History of Changes
Other Study ID Numbers: PROS0022, 97408, PROS0022
Study First Received: May 31, 2007
Last Updated: June 23, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Calcitriol
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 18, 2014