Summary
Phenytoin 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 1 registered trial linking Phenytoin to Prostate Cancer: 1 has completed. The most advanced is PHASE1, PHASE2 (NCT02796898). It plans or enrolled 23 participants. Registered activity dates to 2016. The literature layer holds 3 publications for this pair: 1 meta-analysis, 1 systematic review and 1 clinical trial publication. Publication years run from 2020 to 2023. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
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 | 31.5 (trials 2.5, literature 9.0, tier 15, approved bonus 5.0) |
| Registered trials | 1 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 3 (1 meta-analysis, 1 systematic review, 1 clinical trial publication) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02796898 | Study of the Efficacy, Safety, and Pharmacokinetics of SM88 in Patients With Prostate Cancer 2016 | completed | PHASE1, PHASE2 | 23 |
Published literature
- Meta-analysis Effect of Voltage-Gated Sodium Channel Inhibitors on the Metastatic Behavior of Prostate Cancer Cells: A Meta-AnalysisYildirim-Kahriman S · Pakistan journal of biological sciences : PJBS · 2023 · PMID 37937335
- Clinical trial publication Phase II trial of SM-88, a cancer metabolism based therapy, in non-metastatic biochemical recurrent prostate cancerGartrell BA, Roach M 3rd, Retter A et al. · Investigational new drugs · 2021 · PMID 32924093
- Systematic review Drugs Causing Bone LossVestergaard P · Handbook of experimental pharmacology · 2020 · PMID 31889220
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 Phenytoin approved for Prostate Cancer?
Phenytoin 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 Phenytoin in clinical trials for Prostate Cancer?
ClinicalTrials.gov lists 1 registered trial linking Phenytoin to Prostate Cancer: 1 has completed. The most advanced is PHASE1, PHASE2 (NCT02796898). It plans or enrolled 23 participants. Registered activity dates to 2016.
What does the evidence show for Phenytoin in Prostate Cancer?
Phenytoin has both completed registered trials and synthesis-level publications linked to Prostate Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. 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.