Clinical trial · Interventional
A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
NCT00383487CI-TRIAL-00009170terminatedPhase 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): Extreme toxicity
Summary
Brief summary (as posted)
To determine whether, in this patient population, treatment with calcitriol and Naproxen is more effective in delaying the growth of prostate cancer than treatment with calcitriol alone as seen in historical controls.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcitriol | Drug | — | UNRESOLVED |
| Naproxen-n-butyl nitrate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.
Secondary outcomes (1)
- measure
- Progressive disease in this study's patients, who would be treated with calcitriol and naprosyn, will be compared to that in historical controls of patients treated with calcitriol alone.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Must give written informed consent * Histologically confirmed adenocarcinoma of the prostate * Biochemical relapse after primary radiation therapy or surgery * Normal testosterone levels * 3 rising PSA after nadir, with interval between PSA determinations \> 2 weeks Exclusion Criteria: * Local recurrence by CT scan * Distant metastases by bone scan * Hypercalcemia * Nephrolithiasis * Renal insufficiency (serum creatinine \> 1.8 mg/dl) * Pancreatitis * History of ulcer or gastrointestinal bleeding * More than 6 months of hormone ablation therapy * Concurrent therapy for prostate cancer * Uncontrolled HTN * H/O MI, CVA, TIA * Known coronary disease/cerebrovascular disease * Platelet counts \<50 * Patients on anticoagulants * Patients on lithium
References
Publications (0)
Data not yet available
No reference posted for this study.