Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Luteinizing hormone-releasing hormone (LHRH) analogue
Luteinizing hormone-releasing hormone analogue · 1 trial · 1 indication
Percent of subjects are free of clinical or radiographic progression at 24 months from initiation of treatment
| Arm | Type | Description |
|---|---|---|
| Lead-In Phase - ADT with an LHRH agonist or antagonist | EXPERIMENTAL | Eligible patients will initiate combined androgen deprivation therapy (ADT) with an LHRH agonist or antagonist (e.g. Eligard, Zoladex, Lupron, Orgovyx) in combination with standard dose darolutamide (600 mg twice daily) for a total of 6 months. After this initial "lead-in" phase, patients who have clinical or radiographic progression or do not have at least a ≥50% decline in PSA will remain on combined androgen deprivation and discontinue study. |
| Bipolar Androgen-based Therapy (BAT) Cycle | EXPERIMENTAL | Patients with ≥50% decline in PSA will discontinue combined androgen deprivation and will receive intermittent intramuscular testosterone cypionate (T) at a dose of 400 mg every 4 weeks for a total of 3 injections while on a BAT cycle (12 weeks). |
| Darolutamide Cycle | EXPERIMENTAL | Patient will proceed to a cycle off BAT and start darolutamide alone at 600 mg twice daily for 12 weeks. Patients will continue with alternating cycles of BAT or darolutamide (without ADT) until clinical or radiographic progression. |
| Name | Type | Description |
|---|---|---|
| Testosterone cypionate | DRUG | Intermittent intramuscular testosterone cypionate (T) at a dose of 400 mg every 4 weeks. |
| Luteinizing hormone-releasing hormone (LHRH) analogue | DRUG | Eligible patients will initiate combined androgen deprivation therapy (ADT) with an LHRH agonist or antagonist (e.g. Eligard, Zoladex, Lupron, Orgovyx) in combination with standard dose darolutamide (600 mg twice daily) for a total of 6 months. |
| Darolutamide | DRUG | 600 mg twice daily during the lead-in phase and on darolutamide cycle. |
Inclusion Criteria: * Age ≥ 18 years * Performance status ≤2. * Documented histologically confirmed adenocarcinoma of the prostate. * Baseline PSA ≥1.0 ng/ml. * No prior androgen deprivation therapy (i.e. surgical castration LHRH agonist, LHRH antagonist) as treatment for biochemically recurrent or...