Study on Adding Apalutamide to Radiotherapy and Hormone Therapy for High-Risk Prostate Cancer Patients

Inclusion Criteria

• Diagnosed with prostate cancer confirmed by lab tests.
• Previously had surgery to remove the prostate, with or without lymph node removal.
• For those with a return of cancer signs after surgery: had a very low PSA level within 12 months after surgery and no high PSA levels shortly after surgery.
• For those with persistent PSA after surgery: had a PSA level of 0.1 ng/mL or higher shortly after surgery, confirmed by another test at least 3 weeks later.
• Able to swallow the study drug tablets or mix them with applesauce.
• PSMA-PET scan results at screening must show either no cancer lesions, at least one pelvic lesion without distant spread, or at least one pelvic lesion with distant spread.
• High risk of cancer spreading, defined by a high Gleason score or a fast PSA doubling time.
• No evidence of cancer spread on other scans like CT/MRI or bone scans.
• Good overall health with a performance status score of 0 or 1.

Exclusion Criteria

• History of radiation treatment to the pelvic area for cancer.
• Previous hormone therapy for prostate cancer.
• Previous treatment for cancer signs returning or persistent PSA after surgery, except for surgical treatment of local lesions.
• Prior use of certain medications that affect hormone levels or androgen receptors.
• Allergies or sensitivities to apalutamide, hormone therapy, or their components.
• Previous chemotherapy for prostate cancer.
• Any signs of cancer spread on CT/MRI or bone scans before the study.