David Feldman
Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Drug: Vitamin D (Calcitriol)
Phase:
N/AEligibility
Ages Eligible for Study:
45 years to Any AgeGenders Eligible for Study:
MaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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
Key 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.
Additional Study Details
Official Title:
Calcitriol or Placebo in Men for Prostate Cancer Active SurveillanceAnticipated start date:
2/13/2007Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
ParallelEndpoints:
UnspecifiedPrimary Outcomes:
- 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
Total Number to be Enrolled:
24Total Number to be Enrolled at Stanford:
24More Information
Secondary ID(s):
- 97408
- NCT00482157
- PROS0022
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
4/15/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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