Clinical trial · Interventional
Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia
A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia
NCT00118066CI-TRIAL-00018025terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accruaL, lack of scientific progress
Summary
Brief summary (as posted)
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of calcitriol may prevent prostate cancer. It is not yet known whether calcitriol is more effective than observation in preventing prostate cancer. PURPOSE: This randomized phase II trial is studying how well calcitriol works in preventing prostate cancer in patients with prostatic intraepithelial neoplasia.
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 |
|---|---|---|---|
| Precancerous/Nonmalignant Condition | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| calcitriol | Dietary Supplement | — | UNRESOLVED |
| observation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral calcitriol once daily for 8 weeks. Treatment repeats every 8 weeks for 2 courses. After completion of course 2 (week 16), patients undergo biopsy. Patients continue to receive calcitriol for up to 3 additional weeks while the biopsy is being evaluated. Patients with persistent high-grade prostatic intraepithelial neoplasia (HGPIN) by biopsy receive 2 additional courses of calcitriol.
- interventionNames
- Dietary Supplement: calcitriol
- type
- OTHER
- label
- Arm II
- description
- Patients undergo observation for 16 weeks. At week 16, patients undergo biopsy. Patients with persistent HGPIN by biopsy receive 2 courses of calcitriol as in arm I.
- interventionNames
- Dietary Supplement: calcitriol
- Procedure: observation
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed high-grade prostatic intraepithelial neoplasia * Diagnosed within the past 6 months * No evidence of prostate cancer within the past 6 months * No evidence of palpable nodules on digital rectal exam * Prostate specific antigen ≤ 10 ng/mL within the past 3 months PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * SGOT and SGPT ≤ 1.5 times upper limit of normal Renal * No uncontrolled renal failure * No cancer-related hypercalcemia or kidney stones within the past 5 years Cardiovascular * No uncontrolled coronary artery disease * No uncontrolled congestive heart failure Other * Prior malignancy allowed provided patient was curatively treated and has been disease-free for an appropriate time period for the specific cancer * No known HIV positivity * No active infection * No major depression or suicidal ideation * No other condition that would preclude study compliance * No other uncontrolled medical condition PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for any malignancy Endocrine therapy * At least 2 weeks since prior and no concurrent finasteride (Prosear® or Propecia®) or other androgen suppressor * No concurrent corticosteroids Radiotherapy * Not specified Surgery * Not specified Other * At least 2 weeks since prior phenytoin or phenobarbital * At least 2 weeks since prior ketoconazole * No concurrent administration of any of the following: * Magnesium-containing antacids * Thiazide diuretics * Calcium supplements * Digoxin * Herbal supplements * Pharmacological doses of cholecalciferol (vitamin D) or its derivatives
References
Publications (0)
Data not yet available
No reference posted for this study.