Clinical trial · no report yet · Phase 3
ARASTEP
A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies
- NCT05794906 ↗
- Active not recruiting
- Bayer
- 17 commentary sources found
- Standard
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.
| Channel | Found | |
|---|---|---|
| X threads | 9 | |
| YouTube | 5 | |
| Podcasts | 3 |
The trial
ClinicalTrials.gov- Official title
- A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer
- Phase
- Phase 3
- Status
- Active not recruiting
- Conditions
- Biochemically Recurrent Prostate Cancer
- Interventions
- Darolutamide (BAY1841788, Nubeqa); Placebo matching darolutamide; ADT
- Arms
- Darolutamide+ADT · Experimental
- Placebo+ADT · Placebo comparator
- Enrollment
- 985
- Primary outcomes
- Radiological progression-free survival (rPFS) by Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) assessed by Blinded independent central review (BICR)
- Sponsor
- Bayer
- Start
- Apr 3, 2023
- Primary completion
- Jul 30, 2027 (estimated)
- Results posted
- No
- Registry record
- NCT05794906 · updated Jul 7, 2026
Publications
linked from the registry- Morgans AK, Chehrazi-Raffle A, Niazi T, Shore ND, Ross AE, Roder A, Gomes AJ, Supiot S, Barthelemy P, Hatano K, Ruiz CBC, Yoshida S, Herrera-Imbroda B, Gratton M, Gschwend JE, Hope TA, Joensuu H, Kuss I, Le Berre MA, Dimova-Dobreva M, Fizazi K. Darolutamide plus androgen-deprivation therapy in high-risk biochemical recurrence of prostate cancer (ARASTEP). Future Oncol. 2025 Nov;21(27):3491-3498. doi: 10.1080/14796694.2025.2577633. Epub 2025 Nov 11. PubMed 41216639