Phase 2a Study of High-Dose Testosterone Followed by Targeted Radioligand Therapy for Advanced Prostate Cancer

Inclusion Criteria

• Must have confirmed prostate cancer that has advanced to mCRPC without severe cancer-related symptoms.
• Must show cancer progression through PSA levels or imaging at low testosterone levels.
• Must have a positive PSMA PET scan and be eligible for PSMA-617 treatment.
• Allowed previous treatments include one line of ARPI, sipuleucel-T for mCRPC, and docetaxel in the hormone-sensitive setting.
• Must have an ECOG performance status of 0 or 1, indicating full activity or some restriction in strenuous activities.
• Must have adequate organ and bone marrow function.
• Can have other cancers if they do not interfere with the study treatment.
• If there's a history of heart issues, must have a heart function test showing over 40% ejection fraction within 6 months before joining the study.
• Non-sterilized men with partners who can become pregnant must use effective birth control during the study and for 6 weeks after the last dose of enzalutamide or docetaxel.
• Must understand and agree to the study requirements and sign a consent form, or have a representative do so.

Exclusion Criteria

• Cannot have prostate cancer that has spread to the spine, liver, or brain.
• Cannot have a history of spinal cord compression.
• Cannot have had radiation treatment within 30 days before starting the study treatment.
• Cannot be taking other experimental treatments; must wait 4 weeks after stopping any previous experimental treatments before joining.
• Cannot have uncontrolled health issues like ongoing infections, severe heart problems, or psychiatric conditions that would affect participation in the study.