Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Darolutamide · 1 trial · 3 indications
Rate of testosterone recovery (TR) defined as the proportion of participants achieving testosterone ≥ lower limit of normal by 18 months after completion of study treatment. Participants who withdrew from trial therapy (due to early progression, toxicity, patient/physician decision or death) before completing 2 years of treatment will be excluded from the analysis. Participants who require resumption of androgen deprivation, withdraw, are lost to follow-up, or die before 18 months of post-treatment follow up has been completed without having achieved testosterone recovery ≥ lower limit of normal beforehand will be included in the analysis and will be considered to be non-recovered.
All grade 3-5 adverse events (AE) with treatment attribution of possibly, probably or definitely related to study treatment based on Common Terminology Criteria for Adverse Events (CTCAE) version 5 are counted. Rate is the proportion of treated participants experiencing at least one of these adverse events as defined during the time of observation.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 Short Pharmacokinetics (PK) | EXPERIMENTAL | Enrolled participants will complete study procedures as follows: * Cycle 1: * Day 1 of 28 Day Cycle: Predetermined dose of Relugolix 1x daily. First dose will be administered in-clinic. * Day 1 of 28 Day Cycle: Predetermined dose of Darolutamide 2x daily. First dose will be administered in-clinic. * Cycle 2 through End of Treatment: * Predetermined dose of Relugolix 1x daily. * Predetermined dose of Darolutamide 2x daily. * End of Treatment visit. * Follow Up: every 3 months for 18 months. |
| Cohort 2 Long Pharmacokinetics (PK) | EXPERIMENTAL | Enrolled participants will complete study procedures as follows: * Cycle 1: * Days 1, 2, 8 of 28 Day Cycle: Predetermined dose of Relugolix 1x daily. First dose will be administered in-clinic. * Days 1, 2, 8 of 28 Day Cycle: Predetermined dose of Darolutamide 2x daily. First dose will be administered in-clinic. * Cycle 2: * Day 1 of 28 Day Cycle: Predetermined dose of Relugolix 1x daily. First dose will be administered in-clinic. * Day 1 of 28 Day Cycle: Predetermined dose of Darolutamide 2x daily. First dose will be administered in-clinic. * Cycle 3 through End of Treatment: * Predetermined dose of Relugolix 1x daily. * Predetermined dose of Darolutamide 2x daily. * End of Treatment visit. * Follow Up: every 3 months for 18 months. |
| Name | Type | Description |
|---|---|---|
| Darolutamide | DRUG | Androgen receptor antagonist, tablet taken orally per protocol. |
| Relugolix | DRUG | Gonadotropin-releasing hormone (GnRH) receptor antagonist, tablet taken orally per protocol. |
Inclusion Criteria: * Participants must have histologically or cytologically confirmed prostate cancer. * Hormone-sensitive prostate cancer (with detectable prostate-specific antigen \[PSA\] \> 0.02 ng/ml, testosterone ≥ lower limit of normal \[LLN\] per institutional assay) planned for two years o...
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Darolutamide is an investigational small molecule being studied for the treatment of prostate cancer, including advanced and hormone-sensitive prostate cancer. It is currently in Phase 2 clinical development and is not yet approved by the FDA.
Darolutamide is being developed by Pfizer, Inc., which trades under the ticker PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with prostate cancer.
Darolutamide is in Phase 2 clinical development. It is currently being studied in an active clinical trial that is not yet recruiting participants, and the drug remains investigational, meaning it has not been approved for commercial use.
Darolutamide is being evaluated in a Phase 2 clinical trial with the identifier NCT06463457, titled "Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)." This trial is active but not recruiting and is enrolling 33 male patients aged 18 years and older in the United States.
Darolutamide is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for prostate cancer. The ongoing study is active but not recruiting, and the drug has not yet completed the clinical development process required for regulatory approval.