Study on Intermittent Hormone Therapy with Apalutamide for Metastatic Prostate Cancer

Inclusion Criteria

• Diagnosed with prostate cancer confirmed by lab tests.
• For those not undergoing gender-affirming care: Cancer has spread to at least two areas outside the prostate, as shown by scans.
• For those undergoing gender-affirming care: No evidence of cancer spread is acceptable.
• For those not undergoing gender-affirming care: Testosterone levels above 50 ng/dL at screening, unless already on hormone therapy for up to 3 months.
• No testosterone level requirement for those undergoing gender-affirming care.
• Must be in good general health, with a performance status score of 0 or 1, or 2 or 3 if due to stable physical limitations not related to cancer.
• Must agree not to father a child during the study and for 3 months after the last treatment.
• Must be able to swallow apalutamide tablets whole or with a soft food like applesauce.
• Assigned male at birth, regardless of current gender identity.

Exclusion Criteria

• History of seizures or conditions that increase seizure risk.
• Only cancer spread to pelvic lymph nodes.
• Allergies or intolerance to ingredients in apalutamide.
• Recent severe heart problems, like heart attack or uncontrolled high blood pressure, within 6 months before screening.
• Digestive issues affecting medication absorption.
• Previous removal of both testicles, unless part of gender-affirming care or due to physical development variations.