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Radioisotope Therapy

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

Phase 3

Waitlist Available

Research Sponsored by POINT Biopharma

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

SPLASH Trial Summary

This trial will test a new treatment for prostate cancer that has progressed after other treatments have failed. The goal is to see if it is effective and safe.

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.Check my eligibility

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.See study design

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.

SPLASH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer progressed after treatment with a specific hormone therapy.

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I cannot or do not want to undergo chemotherapy.

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My PSMA-PET scan results are positive.

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I am fully active or can carry out light work.

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My prostate cancer is getting worse despite treatment.

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My cancer has grown by 20% or I have new cancer spots since starting treatment.

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My kidney function is within the required range.

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I will use effective birth control during the study and for 6 months after.

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I am a man aged 18 or older.

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I cannot or do not want to undergo chemotherapy.

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My testosterone levels are very low.

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My prostate cancer has been confirmed by a lab test.

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My bone scan shows two or more new lesions indicating my bone disease is progressing.

SPLASH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Radiographic Progression Free Survival (rPFS)

Secondary outcome measures

Biochemical Progression-Free Survival (bPFS)

Duration of response

Objective Response Rate (ORR)

+2 more

Other outcome measures

Safety and Tolerability (AEs)

SPLASH 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).

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

POINT BiopharmaLead Sponsor

5 Previous Clinical Trials

199 Total Patients Enrolled

2 Trials studying Prostate Cancer

96 Patients Enrolled for Prostate Cancer

Jessica JensenStudy DirectorPOINT Biopharma

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are a part of this research?

"That is correct. The clinical trial mentioned is recruiting patients, as of 11/9/2022. This particular trial was first posted on 2/25/2021 and has since been updated. Up to 415 people are allowed to participate across 42 different sites."

Answered by AI

Are we currently looking for new enrollees in this experiment?

"Yes, the information available on clinicaltrials.gov suggests that this study is still actively recruiting patients. The trial was initially posted on February 25th, 2021 and has been edited most recently on November 9th, 2022."

Answered by AI

Can you tell me how many hospitals are participating in this research project?

"Presently, this study is being conducted at 42 clinical sites. Some of these locations include Philadelphia, Aurora and Nashville; however, there are many other options too. Minimizing travel burden is an important factor to consider when selecting a trial site."

Answered by AI

What other [Lu-177]-PNT2002 research has been undertaken thus far?

"As of right now, 207 studies are underway that involve [Lu-177]-PNT2002. Out of those active trials, 47 have reached Phase 3. Even though the majority of these trials take place in Germantown, Tennessee, there are 9999 locations conducting research for this treatment."

Answered by AI