Floatz Rating
B63/100
Confidence
Indicative
Sponsor
West China Hospital
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
62High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07649421CT.gov PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPC | — | Not Yet Recruiting | — | — | — |
NCT07611110CT.gov AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) | — | Recruiting | — | — | — |
NCT07395804CT.gov How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany | — | Recruiting | — | — | — |
NCT07142551CT.gov Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response | — | Recruiting | — | — | — |
NCT07190300CT.gov TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) | — | Recruiting | — | — | — |
NCT07244341CT.gov A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC) | — | Recruiting | — | — | — |
NCT07103018CT.gov A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001) | — | Recruiting | — | — | — |
NCT07140900CT.gov Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer | — | Recruiting | — | — | — |
NCT06661122CT.gov A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer | — | Recruiting | — | — | — |
NCT06401980CT.gov Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) | — | Recruiting | — | — | — |
Show 26 more trialsShow fewer
NCT06992232CT.gov Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC | — | Recruiting | — | — | — |
NCT06320067CT.gov A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer | — | Recruiting | — | — | — |
NCT06430411CT.gov Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study | — | Not Yet Recruiting | — | — | — |
NCT06177015CT.gov Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC | — | Recruiting | — | — | — |
NCT05762536CT.gov Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC | — | Recruiting | — | — | — |
NCT06120491CT.gov Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents | — | Active Not Recruiting | — | — | — |
NCT05771896CT.gov Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC | — | Withdrawn | — | — | — |
NCT05617885CT.gov Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer | — | Completed | — | — | — |
NCT05701007CT.gov Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland | — | Completed | — | — | — |
NCT05683964CT.gov Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression | — | Active Not Recruiting | — | — | — |
NCT05519449CT.gov Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01) | — | Recruiting | — | — | — |
NCT05383079CT.gov Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men with Metastatic Castration-Resistant Prostate Cancer | — | Active Not Recruiting | — | — | — |
NCT05367440CT.gov Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer | — | Active Not Recruiting | — | — | — |
NCT05413421CT.gov Study of ORIC-944 in Patients With Metastatic Prostate Cancer | — | Recruiting | — | — | — |
NCT04916613CT.gov ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable) | — | Recruiting | — | — | — |
NCT04925648CT.gov Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction | — | Completed | — | — | — |
NCT04335682CT.gov Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide | — | Completed | — | — | — |
NCT04641078CT.gov Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer | — | Unknown | — | — | — |
NCT04070209CT.gov Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X) | — | Active Not Recruiting | — | — | — |
NCT04109729CT.gov Study of Nivolumab in Combination w Radium-223 in Men w Metastatic Castration Resistant Prostate Cancer | — | Active Not Recruiting | — | — | — |
NCT04237584CT.gov A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients | — | Terminated | — | — | — |
NCT03903835CT.gov ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer | — | Recruiting | — | — | — |
NCT03568656CT.gov Study to Evaluate CCS1477 in Advanced Tumours | — | Completed | — | — | — |
NCT03314324CT.gov A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer | — | Completed | — | — | — |
NCT03230734CT.gov Sequencing of Radium-223 and Docetaxel in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer | — | Active Not Recruiting | — | — | — |
NCT02278055CT.gov Non-Randomized Trial Assessing Pain Efficacy With Radium-223 in Symptomatic Metastatic Castration-Resistant Prostate Cancer | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Metastatic Prostate Carcinoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Darolutamide (this asset) | West China Hospital | P3 | B · 63 |
| AXUMIN | VA Greater Los Angeles Healthcare System | P4 | BBB |
| Leuporelin | Mayo Clinic | P4 | BBB |
| Prednisone | Mayo Clinic | P4 | BB |
| Abiraterone | Mayo Clinic | P4 | BB |
| Pembrolizumab | CuraCell TX AB | P2 | BB |
| Degarelix | Praful Ravi, MB BCHir, MRCP | P3 | BB |
| Cabazitaxel | AstraZeneca | P4 | BB |
| Sipuleucel-T | Yale University | P2 | BB |
+42 more in the Metastatic Prostate Carcinoma cohort
Other indications for Darolutamide
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Castration-Resistant Prostate Carcinoma | — | P4 | BBB · 78 |
| Breast Cancer | — | P2 | BBB · 73 |
| Prostate Adenocarcinoma | — | P3 | BB · 66 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Darolutamide in Metastatic Prostate Carcinoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/darolutamide-metastatic-prostate-carcinoma
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