Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04025372 | INTREPId (INTermediate Risk Erection PreservatIon Trial) | PHASE2 | ACTIVE NOT_RECRUITING | 234 | — | — | Jun 1, 2020 | Mar 1, 2028 | Dec 15, 2025 | 11 | United States |
| NCT06282588 | Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers | PHASE2 | RECRUITING | 493 | — | — | Dec 13, 2023 | Dec 31, 2030 | Mar 19, 2026 | 9 | Belgium |
A response is defined as a PSA nadir \<= 0.5 within 6 months from end of treatment
Improvement in PSMA PET metastasis free survival (ppMFS)
EPIC mean changes in sexual subdomain scores over time will be compared, both for change from baseline and absolute scores
EPIC mean changes in hormonal subdomain scores over time will be compared, both for change from baseline and absolute scores
| Arm | Type | Description |
|---|---|---|
| Bicalutamide+GnRH Agonist+Radiation Therapy | EXPERIMENTAL | * Bicalutamide is administered orally on a daily basis * GnRH Agonist as prescribed * Radiation therapy is administered starting 4-16 weeks after ADT |
| Darolutamide+Radiation Therapy | EXPERIMENTAL | * Darolutamide is administered orally twice daily * Radiation therapy is administered starting 4-16 weeks after Darolutamide |
| Phase 2 Open Label | EXPERIMENTAL | Darolutamide for up to 96 weeks (24 months) and primary SOC RT |
| Phase 3 Blinded Experimental | EXPERIMENTAL | Darolutamide + LHRHA for up to 96 weeks (24 months) and primary SOC RT |
| Phase 3 Blinded Comparator | PLACEBO_COMPARATOR | Darolutamide matched placebo + LHRHA for up to 96 weeks (24 months) and primary SOC RT |
| Name | Type | Description |
|---|---|---|
| Bicalutamide | DRUG | Bicalutamide is categorized as an antiandrogen. Antiandrogens are substances that block the effects of testosterone. Cancer of the prostate depends on the male hormone testosterone for its growth. If the amount of testosterone is reduced it is possible to slow down or shrink the cancer. |
| GnRH Agonist | DRUG | In men, GnRH agonists cause the testicles to stop making testosterone. Some GnRH agonists are used to treat prostate cancer. |
| Radiation Therapy | RADIATION | Radiation Therapy is a cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors. |
| Darolutamide | DRUG | Darolutamide belongs to a class of drugs called androgen receptor inhibitors. In the body, these agents compete with androgens for binding to the androgen receptor, which reduces the ability of androgens to promote the growth of prostate cancer cells |
| Darolutamide matched placebo | DRUG | 2x300 mg tablets twice daily, for up to 96 weeks |
| Radiotherapy | RADIATION | Preferred regimens: 60 to 62 Gy delivered in 20 fractions of 3.0 to 3.1Gy per fraction; 36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction, 2-3 fractions per week |
| Zoladex 3.6Mg Implant | DRUG | 3.6 mg, subcutaneous use |
| Zoladex LA | DRUG | 10.8 mg, subcutaneous use |
| Decapeptyl sustained release 22.5 mg | DRUG | 22.5 mg, intramusculair injection |
| Decapeptyl sustained release 11.25 mg | DRUG | 11.25 mg, intramusculair injection |
| Depo-Eligard 45 mg | DRUG | 45 mg, subcutaneous use |
| Depo-Eligard 22.5 mg | DRUG | 22.5 mg, subcutaneous use |
| Depo-Eligard 7.5 mg | DRUG | 7.5 mg, subcutaneous use |
| Firmagon 120 MG Injection | DRUG | 120 mg, subcutaneous use |
| Firmagon 80 MG Injection | DRUG | 80 mg, subcutaneous use |
| Docetaxel | DRUG | 75 mg per square m, IV infusion |
Inclusion Criteria: * Histologically confirmed prostate adenocarcinoma by biopsy within 1 year (365 days) from registration. The most recent biopsy will determine eligibility * National Cancer Center Network (NCCN) intermediate risk prostate cancer, defined as clinical T2b-T2c, Gleason 7, or PSA 10...