Last reviewed · How we verify
NCT03031821: PRIME
Metformin in Patients Initiating ADT as Prevention and Intervention of Metabolic Syndrome
Terminated
Phase 3
Last updated 4 October 2024
What this trial tests
Phase 3 trial testing Metformin in Prostate Cancer in 168 participants. Terminated before completion.
Timeline
12 July 2018
Primary endpoint
24 November 2023
24 November 2023
24 November 2023
Quick facts
| Lead sponsor | Canadian Urologic Oncology Group |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 168 |
| Start date | 12 July 2018 |
| Primary completion | 24 November 2023 |
| Estimated completion | 24 November 2023 |
| Sites | 16 locations across Canada |
Drugs / interventions tested
- Metformin (metformin) — full drug profile →
- Placebo Oral Tablet — full drug profile →
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
- Metabolic Syndrome — all drugs for Metabolic Syndrome →
Sponsor
Canadian Urologic Oncology Group
Who can join
18 and older, male only, with Prostate Cancer or Metabolic Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-centre, double-blind, randomized phase III trial comparing metformin to placebo in patients with advanced prostate cancer starting (or have recently started) androgen deprivation therapy (ADT).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Repurposing non-oncology small-molecule drugs to improve cancer therapy: Current situation and future directions.
Fu L, Jin W, Zhang J, Zhu L, et al · · 2022 · cited 47× · PMID 35256933 · DOI 10.1016/j.apsb.2021.09.006 -
Targeting Mitochondrial OXPHOS and Their Regulatory Signals in Prostate Cancers.
Chen CL, Lin CY, Kung HJ. · · 2021 · cited 39× · PMID 34948229 · DOI 10.3390/ijms222413435 -
Metabolic therapy and bioenergetic analysis: The missing piece of the puzzle.
Duraj T, Carrión-Navarro J, Seyfried TN, García-Romero N, et al · · 2021 · cited 24× · PMID 34749013 · DOI 10.1016/j.molmet.2021.101389 -
Canadian Urological Association guideline on androgen deprivation therapy: Adverse events and management strategies.
Kokorovic A, So AI, Serag H, French C, et al · · 2021 · cited 20× · PMID 34127184 · DOI 10.5489/cuaj.7355 -
Angiogenesis as Therapeutic Target in Metastatic Prostate Cancer - Narrowing the Gap Between Bench and Bedside.
Solimando AG, Kalogirou C, Krebs M. · · 2022 · cited 15× · PMID 35222436 · DOI 10.3389/fimmu.2022.842038 -
Insulin-like growth factor role in determining the anti-cancer effect of metformin: RCT in prostate cancer patients.
Birzniece V, Lam T, McLean M, Reddy N, et al · · 2022 · cited 6× · PMID 35324467 · DOI 10.1530/ec-21-0375 -
UPDATE - Canadian Urological Association guideline on androgen deprivation therapy: Adverse events and management strategies.
Kokorovic A, So AI, Serag H, French C, et al · · 2022 · cited 5× · PMID 35905482 · DOI 10.5489/cuaj.8054 -
Racial disparity in prostate cancer: an outlook in genetic and molecular landscape.
Kaushal JB, Raut P, Muniyan S, Siddiqui JA, et al · · 2024 · cited 4× · PMID 38902476 · DOI 10.1007/s10555-024-10193-8
Verify or expand the search:
- PubMed search for NCT03031821
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Metformin
Trials testing the same drug.
- NCT07275359 — Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations · Phase 1 · not yet recruiting
- NCT07520110 — Metformin to Attenuate Progressive Respiratory Decline in Idiopathic Pulmonary Fibrosis · Phase 3 · not yet recruiting
- NCT07007221 — Clinical Trials to Evaluate Metformin to Treat Depression in People Living With HIV · Phase 2 · not yet recruiting
- NCT07585396 — Inositol in Letrozol Resistant PCOS Women · Phase 2, PHASE3 · not yet recruiting
- NCT07226453 — Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma · Phase 2 · not yet recruiting
Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
- NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
- NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
- NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
- NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT03031821 (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 Canadian Urologic Oncology Group
- Last refreshed: 4 October 2024
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/NCT03031821.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing