Clinical trial · Interventional
Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
Phase II Open Label, Multi-Center Clinical Trial Of Modulation Of Intermediate Endpoint Biomarkers By 1x-Hydroxyvitamin D2 In Patients With Clinically Localized Prostate Cancer And High Grade PIN
NCT00022412CI-TRIAL-00042245completedPhase 2ClinicalTrials.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)
RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before surgery. PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| doxercalciferol | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Observation, then prostatectomy
- description
- Arm 2: Patients undergo observation for 28 days. Patients then undergo prostatectomy.
- interventionNames
- Procedure: conventional surgery
- type
- ACTIVE_COMPARATOR
- label
- Doxercalciferol once daily for 28 days
- description
- Dietary supplement once daily to treat prostate cancer for 28 days
- interventionNames
- Dietary Supplement: doxercalciferol
Primary outcomes (2)
- measure
- Intermediate endpoint biomarker modulation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed localized adenocarcinoma of the prostate * Candidate for prostatectomy PATIENT CHARACTERISTICS: Age: * 21 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * WBC at least 4,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.4 mg/dL * AST no greater than 3 times normal Renal: * Creatinine no greater than 2.0 mg/dL * Calcium no greater than 10.2 mg/dL * No idiopathic urinary calcium stone disease PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * No prior hormonal therapy for prostate cancer * No concurrent hormonal therapy, including luteinizing hormone-releasing hormone agonists, antiandrogens, glucocorticoids, ketoconazole, finasteride, diethylstilbestrol, or progestins Radiotherapy: * No prior brachytherapy or external beam radiotherapy for prostate cancer Surgery: * See Disease Characteristics Other: * At least 7 days since prior vitamin D therapy or calcium supplements * No other concurrent vitamin D analogues or calcium supplements * No concurrent magnesium-containing antacids * No concurrent thiazide-containing diuretics * No concurrent phenytoin, phenobarbital, glutethimide, digoxin, or digitalis
References
Publications (0)
Data not yet available
No reference posted for this study.