Summary
Epirubicin 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 ClinicalTrials.gov lists 2 registered trials linking Epirubicin to Prostate Cancer: 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT00218205). The largest enrolment is 36 participants (NCT00096304). Registration activity spans 2002 to 2004. The literature layer holds 9 publications for this pair: 1 meta-analysis, 3 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2000 to 2016. 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 | 46.0 (trials 3.0, literature 23.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 0 recruiting, 0 active / not yet recruiting, 0 completed, 2 other |
| Linked publications | 9 (5 clinical trial publications, 3 randomised controlled trial publications, 1 meta-analysis) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00218205 | A Study of Epirubicin With Estramustine Phosphate and Celecoxib for the Treatment of Prostate Cancer 2002 | status unknown | Phase 2 | 28 |
| NCT00096304 | Epirubicin and Docetaxel in Treating Patients With Metastatic Prostate Cancer 2004 | terminated | Phase 1 | 36 |
Published literature
- Meta-analysis Chemotherapy with or without estramustine for treatment of castration-resistant prostate cancer: A systematic review and meta-analysisQin Z, Li X, Zhang J et al. · Medicine · 2016 · PMID 27684806
- Clinical trial publication Rechallenge of docetaxel combined with epirubicin given on a weekly schedule in advanced castration-resistant prostate cancer patients previously exposed to docetaxel and abiraterone acetate: a single-institution experiencePetrioli R, Roviello G, Fiaschi AI et al. · Medical oncology (Northwood, London, England) · 2015 · PMID 25636506
- Clinical trial publication Docetaxel and epirubicin compared with docetaxel and prednisone in advanced castrate-resistant prostate cancer: a randomised phase II studyPetrioli R, Pascucci A, Conca R et al. · British journal of cancer · 2011 · PMID 21285986
- Clinical trial publication Survival after cytotoxic chemotherapy in patients with advanced hormone-resistant prostate cancer: a phase II studyStathopoulos GP, Koutantos J, Vaslamatzis MM et al. · Oncology reports · 2009 · PMID 19578775
- Clinical trial publication Comparison of three different chemotherapy regimens containing epirubicin in hormone-refractory prostate cancer patientsErsoy H, Yigitbasi O, Sagnak L et al. · TheScientificWorldJournal · 2008 · PMID 18604442
- Clinical trial publication Weekly docetaxel and epirubicin in treatment of advanced hormone-refractory prostate cancerPetrioli R, Paolelli L, Francini E et al. · Urology · 2007 · PMID 17270637
- Randomized controlled trial Palliation of bone pain in prostate cancer using chemotherapy and strontium-89. A randomized phase II studyNilsson S, Strang P, Ginman C et al. · Journal of pain and symptom management · 2005 · PMID 15857738
- Randomized controlled trial A randomized study comparing epirubicin in a 4-weekly versus a weekly intravenous regimen in patients with metastatic, hormone resistant, prostatic carcinoma: effects on health related quality of lifevan Andel G, Fernandez de Moral P, Caris CT et al. · World journal of urology · 2003 · PMID 12819912
- Randomized controlled trial Quality of life assessment in patients with hormone-resistant prostate cancer treated with epirubicin or with epirubicin plus medroxy progesterone acetate - is it feasible?van Andel G, Kurth KH, Rietbroek RL et al. · European urology · 2000 · PMID 10940698
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 Epirubicin approved for Prostate Cancer?
Epirubicin 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 Epirubicin in clinical trials for Prostate Cancer?
ClinicalTrials.gov lists 2 registered trials linking Epirubicin to Prostate Cancer: 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT00218205). The largest enrolment is 36 participants (NCT00096304). Registration activity spans 2002 to 2004.
What does the evidence show for Epirubicin in Prostate Cancer?
Trials of Epirubicin in Prostate Cancer are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest. 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.