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NCT02933801
ODM-201 Maintenance Therapy in Patients With mCRPC Previously Treated With Novel Hormonal Agents.
Phase 2 trial testing ODM-201 in Prostate Cancer Metastatic in 92 participants. Terminated before completion.
28 June 2021
Quick facts
| Lead sponsor | Swiss Cancer Institute |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 92 |
| Start date | 31 March 2017 |
| Primary completion | 28 June 2021 |
| Estimated completion | 15 November 2023 |
| Sites | 32 locations across France, Switzerland, Spain, Italy |
Drugs / interventions tested
- ODM-201
- Placebo
Conditions studied
- Prostate Cancer Metastatic — all drugs for Prostate Cancer Metastatic →
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
Swiss Cancer Institute
Who can join
18 and older, male only, with Prostate Cancer Metastatic or Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main objective of the trial is to assess impact of maintenance therapy with ODM-201 on radiographic progression-free survival (rPFS) of patients with mCRPC pretreated with novel hormonal agents who have non-progressive disease after chemotherapy with a taxane.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Development and prevalence of castration-resistant prostate cancer subtypes.
Vellky JE, Ricke WA. · · 2020 · cited 110× · PMID 32980775 · DOI 10.1016/j.neo.2020.09.002 -
Molecular Mechanisms Related to Hormone Inhibition Resistance in Prostate Cancer.
Mollica V, Di Nunno V, Cimadamore A, Lopez-Beltran A, et al · · 2019 · cited 35× · PMID 30642011 · DOI 10.3390/cells8010043 -
Darolutamide For Castration-Resistant Prostate Cancer.
Bastos DA, Antonarakis ES. · · 2019 · cited 20× · PMID 31695432 · DOI 10.2147/ott.s197244 -
Darolutamide: An Evidenced-Based Review of Its Efficacy and Safety in the Treatment of Prostate Cancer.
Crawford ED, Stanton W, Mandair D. · · 2020 · cited 19× · PMID 32765070 · DOI 10.2147/cmar.s227583 -
New Frontiers in Prostate Cancer Treatment: Are We Ready for Drug Combinations with Novel Agents?
Aurilio G, Cimadamore A, Santoni M, Nolè F, et al · · 2020 · cited 9× · PMID 32580469 · DOI 10.3390/cells9061522 -
Darolutamide Maintenance in Patients With Metastatic Castration-Resistant Prostate Cancer With Nonprogressive Disease After Taxane Treatment (SAKK 08/16).
Gillessen S, Procopio G, Hayoz S, Kremer E, et al · · 2023 · cited 8× · PMID 36753698 · DOI 10.1200/jco.22.01726 -
The androgen receptor-targeted proteolysis targeting chimera and other alternative therapeutic choices in overcoming the resistance to androgen deprivation treatment in prostate cancer.
Li L, Xu J. · · 2023 · cited 5× · PMID 36203075 · DOI 10.1007/s12094-022-02957-x -
A Bayesian Network Meta-analysis of Systemic Treatments for Metastatic Castration-Resistant Prostate Cancer in First- and Subsequent Lines.
Wosny M, Aeppli S, Fischer S, Peres T, et al · · 2025 · PMID 40493311 · DOI 10.1007/s11523-025-01148-2
Verify or expand the search:
- PubMed search for NCT02933801
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ODM-201
Trials testing the same drug.
- NCT03314324 — A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer · Phase 2 · completed
Other recruiting trials for Prostate Cancer Metastatic
Currently open trials in the same condition.
- NCT07292168 — A Phase 1b/2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Ex · Phase 1, PHASE2 · recruiting
- NCT06165302 — Exercise in Prostate Cancer · NA · recruiting
- NCT07484971 — Study of the Epidemiological, Clinical, Diagnostic, and Therapeutic Characteristics of Prostate Cancers in Algeria · recruiting
- NCT06972628 — Treatment of Patients With Progressive mCRPC With 177Lu-PSMA-617 · Phase 2 · recruiting
- NCT07089550 — PSMA PET for Treatment Response evaLuation of systemIC Therapies in prostAte caNcer (PELICAN) · recruiting
Other Swiss Cancer Institute trials
Trials by the same sponsor.
- NCT07158489 — Overcoming Resistance to Immunotherapy Combining Gemcitabine With Ivonescimab in Advanced NSCLC · Phase 2 · not yet recruiting
- NCT06835049 — Feasibility of Total Neoadjuvant Treatment With HYPErthermia in Patients With High-risk Extremity and Trunk Soft Tissue · Phase 2 · recruiting
- NCT06452394 — NEODOXy: Targeting Breast Cancer Stem Cells With Doxycycline · Phase 2 · recruiting
- NCT06114108 — Trial Comparing Systemic Therapy Alone and With Local Ablative Treatment for Stage IV NSCL Cancer Patients · NA · recruiting
- NCT04629781 — Open-label Dose Escalation Phase 1b Trial of a New Micellar Docetaxel Compound in Patients With mCRPC · Phase 1 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02933801 (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 Swiss Cancer Institute
- Last refreshed: 13 March 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/NCT02933801.
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