177Lu-PSMA-I&T for Prostate Cancer

Recruiting at 60 trial locations

Overseen By Darcy Denner

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Curium US LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new radioactive drug against standard hormone therapy in men with advanced prostate cancer that doesn't respond to usual treatments. The drug targets and kills cancer cells using radiation. The drug being tested, 225Ac-PSMA-617, has shown promise in inducing complete responses in patients with metastatic castrate-resistant prostate cancer who were resistant to standard therapies.

Eligibility Criteria

Men over 18 with advanced prostate cancer that's resistant to hormone therapy can join. They must have tried and progressed on treatments like abiraterone or enzalutamide, but not more than one type. A positive PSMA-PET scan is needed, and they should be effectively castrated with low testosterone levels. HIV or hepatitis B/C patients may qualify if well-managed. Participants need a life expectancy of at least 6 months and agree to use contraception.

Inclusion Criteria

My cancer has worsened, shown by rising PSA levels, growth of tumors, or new bone lesions.

Life expectancy of at least 6 months

My hepatitis B or C symptoms are under control.

Exclusion Criteria

My physical functioning is somewhat limited.

I have had chemotherapy for prostate cancer that did not respond to hormone therapy, with some exceptions.

Participants who have a pregnant partner or are capable of fathering a child and who are unwilling to take precautions to prevent potential harm to the fetus or prevent pregnancy

Treatment Details

Interventions

• 177Lu-PSMA-I&T (Radioisotope Therapy)
• Abiraterone with Prednisone or Enzalutamide (Hormone Therapy)

Trial Overview This study compares the safety and effectiveness of a new treatment called 177Lu-PSMA-I&T against standard hormone therapies (abiraterone with prednisone or enzalutamide) in men whose prostate cancer has spread despite castration. It's an open-label trial where everyone knows which treatment they're getting, and it randomly assigns participants to either group.

Participant Groups

Group I: Investigational Drug Experimental Treatment 1 Intervention

177Lu-PSMA-I\&T

Group II: Standard Of Care Hormone Therapy Active Control 1 Intervention

Abiraterone with Prednisone or Enzalutamide

Who Is Running the Clinical Trial?

Curium US LLC

Lead Sponsor

Trials

6

Recruited

1,000+