Summary
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Prostate Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Prostate Cancer. ClinicalTrials.gov lists 4 registered trials linking Indomethacin to Prostate Cancer: 1 is currently recruiting; 1 has completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT02849990). The largest enrolment is 130 participants (NCT07607990). Registration activity spans 2017 to 2026. The literature layer holds 2 publications for this pair: 2 clinical trial publications. Publication years run from 2008 to 2018. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Prostate Cancer ranks 50 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Low-grade (Gleason 6/Grade Group 1): active surveillance appropriate in 40-50% — many will never need treatment; high-grade: lethal without treatment within 5-10 years.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 32.0 (trials 8.0, literature 4.0, tier 15, approved bonus 5.0) |
| Registered trials | 4 total: 1 recruiting, 0 active / not yet recruiting, 1 completed, 2 other |
| Linked publications | 2 (2 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ACP3 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT02849990 | A Phase II Neoadjuvant Study of Apalutamide, Abiraterone Acetate, Prednisone, Degarelix and Indomethacin in Men With Localized Prostate Cancer Pre-prostatectomy 2017 | completed | Phase 2 | 22 |
| NCT07607990 | Effects of Rectal Indomethacin Suppository on Postoperative CRBD in Patients Undergoing LRP 2026 | recruiting | Not applicable | 130 |
| NCT05597878 | Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy 2023 | terminated | PHASE2, PHASE3 | 58 |
| NCT02935205 | Enzalutamide and Indomethacin in Treating Patients With Recurrent or Metastatic Hormone-Resistant Prostate Cancer 2017 | status unknown | PHASE1, PHASE2 | 38 |
Published literature
- Clinical trial publication Prospective comparison among three intrarectal anesthetic treatments combined with periprostatic nerve block during transrectal ultrasonography-guided prostate biopsyValdez-Flores RA, Campos-Salcedo JG, Torres-Gomez JJ et al. · World journal of urology · 2018 · PMID 29170792
- Clinical trial publication Phase I trial of PC-Spes2 in advanced hormone refractory prostate cancerShabbir M, Love J, Montgomery B · Oncology reports · 2008 · PMID 18288423
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ACP3. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Indomethacin approved for Prostate Cancer?
Indomethacin has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Prostate Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Prostate Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Indomethacin in clinical trials for Prostate Cancer?
ClinicalTrials.gov lists 4 registered trials linking Indomethacin to Prostate Cancer: 1 is currently recruiting; 1 has completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT02849990). The largest enrolment is 130 participants (NCT07607990). Registration activity spans 2017 to 2026.
What does the evidence show for Indomethacin in Prostate Cancer?
Indomethacin has 1 completed trial and 2 linked publications for Prostate Cancer. Completed trials may or may not have posted results; follow the NCT links to check. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL, in this case via the biomarker or target ACP3. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-06. Page built 2026-10-07.