Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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) |
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 |
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| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| 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:
|
Neoplasms Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases Calcitriol Vitamin D Vitamins Micronutrients |
Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013