Clinical trial · Interventional
Calcitriol or Placebo in Men for Prostate Cancer Active Surveillance
NCT00482157CI-TRIAL-00056873withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vitamin D (Calcitriol) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- changes in expression of biomarkers as assessed by prostate biopsy
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.