Clinical trial · no report yet · Phase 3
PROTEUS
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
- NCT03767244 ↗
- Active not recruiting
- Janssen Research & Development, LLC
- 3 commentary sources found
- Focused
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Commentary we found
Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built. Commentary is thin so far, so the report would be short.
| Channel | Found | |
|---|---|---|
| X threads | 3 |
The trial
ClinicalTrials.gov- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
- Phase
- Phase 3
- Status
- Active not recruiting
- Conditions
- Prostatic Neoplasms
- Interventions
- Apalutamide; Androgen Deprivation Therapy (ADT); Placebo
- Arms
- Apalutamide + ADT · Experimental
- Placebo + ADT · Experimental
- Enrollment
- 2,517
- Primary outcomes
- Percentage of Participants with Pathologic complete response (pCR)
- Metastasis-Free Survival (MFS)
- Sponsor
- Janssen Research & Development, LLC
- Start
- Jun 11, 2019
- Primary completion
- Dec 1, 2026 (estimated)
- Results posted
- No
- Registry record
- NCT03767244 · updated Sep 25, 2026
Publications
linked from the registry- Taplin ME, Gleave M, Shore ND, Lopez-Gitlitz A, Kretschmer A, Efstathiou E, Nguyen PL, Damiao R, Kamoto T, Ross A, Briganti A, Hadaschik BA, Heidenreich A, Juarez Soto A, Ye H, Gotto G, Rooney B, Tian SK, Wetherhold L, Miladinovic B, McCarthy SA, Evans CP, Kibel AS; PROTEUS Investigators. Perioperative Apalutamide in High-Risk Localized Prostate Cancer. N Engl J Med. 2026 Aug 6;395(6):546-560. doi: 10.1056/NEJMoa2603878. Epub 2026 May 31. PubMed 42223077
- Ravi P, Kwak L, Xie W, Kelleher K, Acosta AM, McKay RR, Kibel AS, Taplin ME. Neoadjuvant Novel Hormonal Therapy Followed by Prostatectomy versus Up-Front Prostatectomy for High-Risk Prostate Cancer: A Comparative Analysis. J Urol. 2022 Oct;208(4):838-845. doi: 10.1097/JU.0000000000002803. Epub 2022 Sep 9. PubMed 36082554