SPLASH Patient Summary

SPLASH

This trial is for people with metastatic castration-resistant prostate cancer (mCRPC) who have progressed following treatment with an androgen receptor pathway inhibitor (ARPI), but who haven't yet received chemotherapy for mCRPC.

SPLASH Summary

The purpose of this trial is to evaluate the efficacy and safety of 177 Lu-PNT2002 in people with mCRPC who have progressed following treatment with an androgen receptor pathway inhibitor (ARPI), such as abiraterone or enzalutamide, but who haven't yet received chemotherapy for mCRPC.

During the trial, all participants will be treated with either 177 Lu-PNT2002 or with the current standard of care therapy. Everyone receives active treatment in this study. There is no placebo (inactive treatment).

Participants who are receiving standard of care and experience progression of their disease (confirmed by radiologic testing) may be eligible to switch therapies to 177 Lu-PNT2002. Participants from both parts of the study will receive long-term follow up for up to 5 years.

What is the purpose?

The main objective of the trial is to find out if 177 Lu-PNT2002 is safe and can effectively slow down or stop the growth of mCPRC. Your participation in this study, if you are eligible, can help improve the understanding of this therapy and its potential benefits, helping make it potentially available to more people in the future.

What type of therapy is being studied?

177 Lu-PNT2002 is a radioligand therapy (RLT). RLT is an innovative approach to treating certain types of cancer, including prostate cancer. It works by delivering a precise dose of radiation directly to a specific target.

A radioligand is made of three parts: a radioisotope, which emits therapeutic radiation to kill nearby cells, a ligand, which can direct the drug to a specific target, like the PSMA target expressed by prostate cancer cells in the case of 177 Lu-PNT2002, and a linker, which holds the two together.

Who can participate?

  • Participation in this clinical trial is determined using eligibility criteria. Some key eligibility criteria are provided below.
  • Documented progressive mCRPC
  • Previous treatment with at least one ARPI (abiraterone, enzalutamide, darolutamide, or apalutamide)
  • PSMA PET scan positive as per central review
  • Adequate organ function per laboratory assessment
  • ECOG performance status: 0-1
  • Have not received any prior cytotoxic chemotherapy for CRPC (i.e. cabazitaxel, docetaxel)
    • Chemotherapy for HSPC is allowed if the last dose was administered >1 year prior to consent *

Complete criteria available online at clinicaltrials.gov under NCT04647526 .

Possible Benefits:

  • This therapy could slow down or stop the progression of prostate cancer and potentially prolonging life
  • Participants will be under close medical supervision for safety during the study period

Possible Risks:

  • The use of 177 Lu-PNT2002 may provide no benefit for preventing disease progression
  • The use of 177 Lu-PNT2002 may cause side-effects

Clinical Trial Sites:

This is a phase 3 trial that will enroll 415 participants across the United States, Canada, and Europe. The trial began February 2021 and this trial is scheduled to finish by March 2028. A full listing of trial sites can be found here .

Organization: POINT Biopharma

For additional information go to SPLASH trial website or contact info@splashtrial.com

If you are interested in this trial, review the following: 

PHEN Contact: 617-481-4020

Please Note: This information is provided for educational and awareness purposes. The patient and his doctor will decide on clinical trial participation.

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