Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Testosterone Cypionate · 1 trial · 1 indication
Defined as (at least one of the 3 criteria below): * Bone progression according to the Prostate Cancer Working Group 3 (PCWG3): * The first bone scan with ≥2 new lesions compared to baseline is observed \<12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); * The first bone scan with ≥2 new lesions compared to baseline is observed ≥12 weeks from randomization and the new lesions are verified on the next bone scan ≥6 weeks later (a total of ≥2 new lesions compared to baseline). * Progression of soft tissue lesions measured by CT or MRI as defined in modified RECIST criteria. * •Death from any cause. The first bone scan with ≥2 new lesions compared to baseline is observed ≥12 weeks from randomization and the new lesions are verified on the next bone scan ≥6 weeks later (a total of ≥2 new lesions compared to baseline).
| Arm | Type | Description |
|---|---|---|
| ExBAT Arm | EXPERIMENTAL | Testosterone Cypionate 400 mg IM on Day 1 and Darolutamide 1,200mg/day (two 300 tablets every 12 hours) p.o. for 28 days, from day 29 to day 56 followed by a washout period of 7 days (63-day cycles), until loss of benefit (disease progression and/or limiting toxicity). |
| Name | Type | Description |
|---|---|---|
| Testosterone Cypionate | DRUG | One administration every 63 cycles until progression or unacceptable toxicity or completion of treatment phase (54 weeks; 6 cycles), whichever comes first. |
| Darolutamide | DRUG | During 4 weeks, from day 29 to day 56 of each 63-day cycle (+- 3 days) until progression or unacceptable toxicity or completion of treatment phase (54 weeks; 6 cycles), whichever comes first. |
Inclusion Criteria: 1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements. 2. Male aged 18 years and above. 3. Histol...
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