Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (NCT04136353)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Men aged 18 years and older, with pathological diagnosis of adenocarcinoma of the prostate
2. EITHER planned for primary RT and judged to be at very high risk for recurrence based on any of the following:
3. Grade Group 5, OR
4. Grade Group 4 AND one or more of the following: clinical T2b-4 OR MRI with seminal vesicle invasion OR extracapsular extension OR PSA\* \> 20ng/mL, OR
5. Pelvic nodal involvement (involvement of lymph nodes (LNs) at or below the bifurcation of the aorta into the common iliac arteries) defined radiologically as greater than 10mm on short axis using standard CT or MRI, or pathologically confirmed (PSMA PET alone is not considered enough if ≤ 10mm) OR Post-radical prostatectomy ≤ 365 days prior to randomisation and planned for RT with PSA\* ≥ 0.1 ng/mL that has risen or remained stable (within ≤ 0.05 ng/mL) since a previous level at least 1 week earlier, judged to be at very high risk for recurrence based on any of the following:
6. Grade Group 5, OR
7. Grade Group 4 AND pT3a or higher, OR
8. Pelvic nodal involvement (involvement of LNs at or below the bifurcation of the aorta into the common iliac arteries) defined radiologically as greater than 10mm on short axis using standard CT or MRI, or pathologically confirmed (PSMA PET alone is not considered enough if ≤ 10mm) \* This PSA level must be measured within 60 days prior to randomisation. However, if a participant has already commenced endocrine therapy (ET) for prostate cancer, this PSA level must be measured within 180 days prior to commencing ET.
9. Adequate bone marrow function: Haemoglobin ≥ 100g/L, white cell count (WCC) ≥ 4.0x109/L, absolute neutrophil count (ANC) ≥ 1.5x109/L and platelets \> 100 x 109/L
10. Adequate liver function: alanine aminotransferase (ALT) \< 2 x upper limit of normal (ULN) and total bilirubin \< 1.5 x ULN, (or if total bilirubin is between 1.5 - 2 x ULN, they must have a normal conjugated bilirubin)
11. Adequate renal function: calculated creatinine clearance \> 30 mL/min (Cockroft-Gault)
12. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (93 Sites)

• Dana-Farber Cancer Institute — Boston, Massachusetts
• Dana Farber Cancer Institute - St. Elizabeth's — Brighton, Massachusetts
• Lahey Hospital and Medical Center — Burlington, Massachusetts
• Dana Farber Cancer Institute - Milford — Milford, Massachusetts
• XCancer Omaha/Urology Cancer Center — Omaha, Nebraska
• Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey
• New Jersey Urology Saddle Brook — Clifton, New Jersey
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey
• Memorial Sloan Kettering Bergen — Montvale, New Jersey
• New Jersey Urology Voorhees — Voorhees Township, New Jersey
• New Mexico Oncology and Hematology Specialists — Albuquerque, New Mexico
• Memorial Sloan Kettering Commack — Commack, New York
• Memorial Sloan Kettering Westchester — Harrison, New York
• New York University Langone Long Island — Mineola, New York
• New York University Langone Medical Center — New York, New York
• Memorial Sloan Kettering Cancer Center — New York, New York
• Memorial Sloan Kettering Nassau — Uniondale, New York
• Dayton Physicians Network — Kettering, Ohio
• Seattle Cancer Care Alliance — Seattle, Washington
• Border Medical Oncology Research Unit — Albury, New South Wales
• Gosford Hospital — Gosford, New South Wales
• GenesisCare Newcastle — Newcastle, New South Wales
• Calvary Mater Newcastle — Newcastle, New South Wales
• Shoalhaven District Memorial Hospital — Nowra, New South Wales
• St Vincent's Public Hospital — Sydney, New South Wales

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.