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NCT00383487
A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer
Phase 2 trial testing Calcitriol in Prostatic Neoplasms in 20 participants. Terminated before completion.
1 July 2007
Quick facts
| Lead sponsor | Stanford University |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 March 2005 |
| Primary completion | 1 July 2007 |
| Estimated completion | 1 July 2007 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Calcitriol (CALCITRIOL) — full drug profile →
- Naproxen-n-butyl nitrate — full drug profile →
Conditions studied
- Prostatic Neoplasms — all drugs for Prostatic Neoplasms →
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
Stanford University
Who can join
Adults 18 to 90, male only, with Prostatic Neoplasms or Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- PSA response - 50% PSA decline, PSA progression, PSA response duration, progressive disease, time to PSA progression.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Nitric oxide-based multi-synergistic nanomedicine: an emerging therapeutic for anticancer.
Tang Y, Li Q, Zhou Z, Bai H, et al · · 2024 · cited 8× · PMID 39497134 · DOI 10.1186/s12951-024-02929-z -
Should androgen deprivation therapy and other systemic treatments be used in men with prostate cancer and a rising PSA post-local treatments?
Patrikidou A, Zilli T, Baciarello G, Terisse S, et al · · 2021 · cited 7× · PMID 34707693 · DOI 10.1177/17588359211051870
Verify or expand the search:
- PubMed search for NCT00383487
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT04801303 — Evaluation of the Effects of Calcitriol's in the Neurological Symptoms of Friedreich's Ataxia Patients · Phase 4 · completed
- NCT05765617 — Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients · Phase 2 · completed
- NCT04967469 — Comparison of Serum Calcium Level Between Preoperative Vitamin D and Non-vitamin D Regimen of Total Parathyroidectomy in · NA · completed
Other recruiting trials for Prostatic Neoplasms
Currently open trials in the same condition.
- NCT07285057 — Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With Prostate Cancer on Active Surveillance · Phase 2 · recruiting
- NCT07319871 — A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer · Phase 1 · recruiting
- NCT07335224 — Men With Prostate Cancer: Optimizing Wellness by Enhanced Relief From Hot Flashes With Acupuncture · NA · recruiting
- NCT07451002 — A Study to Assess Adherence to Apalutamide in Metastatic Hormone-Sensitive Prostate Cancer Participants in France · recruiting
- NCT06547398 — Prostate Adaptive Radiation Therapy · NA · recruiting
Other Stanford University trials
Trials by the same sponsor.
- NCT05945147 — Ketamine and Midazolam Infusions for CRPS: Feasibility Study · Phase 2 · withdrawn
- NCT04225949 — Patients Understanding of PROM Graphs · NA · withdrawn
- NCT06273098 — School-Based Bladder Health Intervention · NA · withdrawn
- NCT04652635 — Management of Nailbed Injuries · NA · withdrawn
- NCT05443503 — Stanford Spine Keeper - Managing Your Low Back Pain · NA · suspended
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00383487 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Stanford University
- Last refreshed: 25 January 2013
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00383487.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing