Summary
Methoxsalen 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ClinicalTrials.gov lists 2 registered trials linking Methoxsalen to Prostate Cancer: 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is PHASE1, PHASE2 (NCT02796898). It plans or enrolled 23 participants. Registered activity dates to 2016. The literature layer holds 1 publication for this pair: 1 clinical trial publication. The dated items are from 2021. 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 | 25.5 (trials 3.5, literature 2.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 1 other |
| Linked publications | 1 (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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT06836648 | Single Patient Compassionate Use of X-PACT in Salvage Treatment of Prostate Cancer | available | Not applicable | — |
| NCT02796898 | Study of the Efficacy, Safety, and Pharmacokinetics of SM88 in Patients With Prostate Cancer 2016 | completed | PHASE1, PHASE2 | 23 |
Published literature
- 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
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 Methoxsalen approved for Prostate Cancer?
Methoxsalen 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 Methoxsalen in clinical trials for Prostate Cancer?
ClinicalTrials.gov lists 2 registered trials linking Methoxsalen to Prostate Cancer: 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is PHASE1, PHASE2 (NCT02796898). It plans or enrolled 23 participants. Registered activity dates to 2016.
What does the evidence show for Methoxsalen in Prostate Cancer?
Methoxsalen has 1 completed trial and 1 linked publication 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.