Lu-177 PSMA Therapy for Prostate Cancer

(SPLASH Trial)

Recruiting at54 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a radioactive treatment in patients with advanced prostate cancer that hasn't responded to other treatments. The treatment targets and kills cancer cells using radiation and has shown promising outcomes, including reduced disease progression and improved overall survival.

Research Team

Jessica Jensen

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread, despite previous treatments like abiraterone or enzalutamide. They should not want chemotherapy, have a low risk of AIDS (if HIV-positive), show signs of worsening cancer, and have proper organ function. Contraception is required for those with partners at risk of pregnancy.

Inclusion Criteria

Bone marrow reserve: i. White blood cell (WBC) count ≥2.5 × 10^9/L OR absolute neutrophil count (ANC) ≥1.5 × 10^9/L

I am HIV positive but at low risk for AIDS.

Signed informed consent

Exclusion Criteria

My bone scan shows much more activity in bones than in soft tissues, with little to no activity in the urinary tract.

Concurrent illness that may jeopardize the patient's ability to undergo study procedures

My condition worsened after two or more ARAT treatments.

Treatment Details

Interventions

• Abiraterone (Hormone Therapy)
• Enzalutamide (Hormone Therapy)
• [Lu-177]-PNT2002 (Radioisotope Therapy)

Trial Overview The trial tests [Lu-177]-PNT2002 effectiveness in men whose prostate cancer worsened after second-line hormonal therapies. Participants will either receive this new treatment or continue with standard care options like abiraterone or enzalutamide as decided by the study team.

Participant Groups

Group I: [Lu-177]-PNT2002 (Arm A) Experimental Treatment 1 Intervention

\[Lu-177\]-PNT2002 (6.8 GBq (±10%) every 8 weeks for 4 cycles)

Group II: Control Arm (Arm B) Active Control 2 Interventions

Abiraterone (1000 mg orally qd with: 5 mg bid prednisone or 0.5 mg qd dexamethasone) or enzalutamide (160 mg orally qd).

Who Is Running the Clinical Trial?

POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company

Lead Sponsor

Trials

5

Recruited

670+

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

POINT Biopharma

Lead Sponsor

Trials

6

Recruited

720+