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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
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 moreOther 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.
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bone scan shows much more activity in bones than in soft tissues, with little to no activity in the urinary tract.My condition worsened after two or more ARAT treatments.I am HIV positive but at low risk for AIDS.I am experiencing symptoms or have been diagnosed with potential spinal cord compression.My cancer progressed after treatment with a specific hormone therapy.I cannot or do not want to undergo chemotherapy.I am willing to start ARAT therapy if placed in Treatment Arm B.I have cancer, but it's not low-grade bladder cancer or non-melanoma skin cancer.My PSMA-PET scan results are positive.I have taken PARP inhibitors for prostate cancer.I started or increased my pain medication for cancer-related pain within the last 30 days.My organs work well without needing blood transfusions.I have had seizures and am planned to receive enzalutamide.I can follow the study's schedule and visit requirements despite personal challenges.I am fully active or can carry out light work.My prostate cancer is getting worse despite treatment.My cancer has grown by 20% or I have new cancer spots since starting treatment.My kidney function is within the required range.I have previously received PSMA-targeted radioligand therapy.I will use effective birth control during the study and for 6 months after.I have liver metastases larger than 1 cm.I have not had major surgery in the last 30 days.I have not had chemotherapy for advanced prostate cancer but may have had it over a year ago for early-stage.I have had treatment with radioactive drugs.I have not had prostate cancer treatment in the last 28 days, except for some specific initial treatments.I have been on a stable dose of bone-targeted therapy for at least 4 weeks.I am a man aged 18 or older.I cannot or do not want to undergo chemotherapy.My liver functions within normal limits, or slightly above if I have Gilbert's syndrome.I don't have any health issues that prevent me from receiving ARAT therapy.I am not allergic to specific cancer imaging agents or their components.My testosterone levels are very low.My prostate cancer has specific cell types but no small cell components.My cancer has spread to my brain.My prostate cancer has been confirmed by a lab test.My bone scan shows two or more new lesions indicating my bone disease is progressing.I have had immunotherapy before, but not sipuleucel-T.I haven't had a heart attack, blood clot, unstable heart pain recently, and my heart pumps well.
Research Study Groups:
This trial has the following groups:- Group 1: [Lu-177]-PNT2002 (Arm A)
- Group 2: Control Arm (Arm B)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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