← Back to Search

Radioisotope Therapy

Lu-177 PSMA Therapy for Prostate Cancer (SPLASH Trial)

Phase 3
Waitlist Available
Research Sponsored by POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Progression on previous treatment with one ARAT (abiraterone or enzalutamide or darolutamide or apalutamide) in either the CSPC or CRPC setting
Ineligible or averse to chemotherapeutic treatment options.
Must not have
A superscan on bone scan defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity
Patients who progressed on 2 or more lines of ARATs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
[Lu-177]-PNT2002 may cause nausea, fatigue, dry mouth, reduced blood cell counts leading to increased infection risk or bleeding problems, kidney issues due to radiation exposure, and potential allergic reactions to its components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer progressed after treatment with a specific hormone therapy.
Select...
I cannot or do not want to undergo chemotherapy.
Select...
My PSMA-PET scan results are positive.
Select...
I am fully active or can carry out light work.
Select...
My prostate cancer is getting worse despite treatment.
Select...
My cancer has grown by 20% or I have new cancer spots since starting treatment.
Select...
My kidney function is within the required range.
Select...
I will use effective birth control during the study and for 6 months after.
Select...
I am a man aged 18 or older.
Select...
I cannot or do not want to undergo chemotherapy.
Select...
My testosterone levels are very low.
Select...
My prostate cancer has been confirmed by a lab test.
Select...
My bone scan shows two or more new lesions indicating my bone disease is progressing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My bone scan shows much more activity in bones than in soft tissues, with little to no activity in the urinary tract.
Select...
My condition worsened after two or more ARAT treatments.
Select...
I am experiencing symptoms or have been diagnosed with potential spinal cord compression.
Select...
I have cancer, but it's not low-grade bladder cancer or non-melanoma skin cancer.
Select...
I have taken PARP inhibitors for prostate cancer.
Select...
I have had seizures and am planned to receive enzalutamide.
Select...
I have previously received PSMA-targeted radioligand therapy.
Select...
I have liver metastases larger than 1 cm.
Select...
I have had treatment with radioactive drugs.
Select...
I have not had prostate cancer treatment in the last 28 days, except for some specific initial treatments.
Select...
I am not allergic to specific cancer imaging agents or their components.
Select...
My prostate cancer has specific cell types but no small cell components.
Select...
My cancer has spread to my brain.
Select...
I have had immunotherapy before, but not sipuleucel-T.
Select...
I haven't had a heart attack, blood clot, unstable heart pain recently, and my heart pumps well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Radiographic Progression Free Survival (rPFS)
Secondary study objectives
Biochemical Progression-Free Survival (bPFS)
Duration of response
Objective Response Rate (ORR)
+2 more
Other study objectives
Safety and Tolerability (AEs)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: [Lu-177]-PNT2002 (Arm A)Experimental Treatment1 Intervention
\[Lu-177\]-PNT2002 (6.8 GBq (±10%) every 8 weeks for 4 cycles)
Group II: Control Arm (Arm B)Active Control2 Interventions
Abiraterone (1000 mg orally qd with: 5 mg bid prednisone or 0.5 mg qd dexamethasone) or enzalutamide (160 mg orally qd).

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Radioligand therapy, such as [Lu-177]-PNT2002, targets prostate-specific membrane antigen (PSMA) on cancer cells, delivering localized radiation to destroy them while sparing surrounding healthy tissue. This targeted approach is crucial for prostate cancer patients as it potentially reduces side effects compared to traditional therapies. Other common treatments include androgen deprivation therapy (ADT), which reduces androgen levels to slow cancer growth, and chemotherapy, which uses drugs to kill rapidly dividing cells. Understanding these mechanisms helps in choosing the most effective and personalized treatment plan.
Biomarkers to personalize treatment with 177Lu-PSMA-617 in men with metastatic castration-resistant prostate cancer - a state of the art review.Lutetium-177 prostate-specific membrane antigen (PSMA) theranostics: practical nuances and intricacies.

Find a Location

Who is running the clinical trial?

POINT Biopharma, a wholly owned subsidiary of Eli Lilly and CompanyLead Sponsor
4 Previous Clinical Trials
245 Total Patients Enrolled
1 Trials studying Prostate Cancer
142 Patients Enrolled for Prostate Cancer
POINT BiopharmaLead Sponsor
5 Previous Clinical Trials
293 Total Patients Enrolled
2 Trials studying Prostate Cancer
190 Patients Enrolled for Prostate Cancer
Jessica JensenStudy DirectorPOINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

[Lu-177]-PNT2002 (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04647526 — Phase 3
Prostate Cancer Research Study Groups: [Lu-177]-PNT2002 (Arm A), Control Arm (Arm B)
Prostate Cancer Clinical Trial 2023: [Lu-177]-PNT2002 Highlights & Side Effects. Trial Name: NCT04647526 — Phase 3
[Lu-177]-PNT2002 (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04647526 — Phase 3
~91 spots leftby Oct 2025