Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance
Primary Purpose
Prostatic Neoplasms, Prostate Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamin D (Calcitriol)
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms
Eligibility 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.
Sites / Locations
Outcomes
Primary Outcome Measures
changes in expression of biomarkers as assessed by prostate biopsy
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00482157
Brief Title
Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance
Official Title
Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Study Start Date
February 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
Brief Summary
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Vitamin D (Calcitriol)
Primary Outcome Measure Information:
Title
changes in expression of biomarkers as assessed by prostate biopsy
Time Frame
6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph C. Presti Jr.
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance
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