SPLASH Patient Summary

SPLASH

This trial is for male patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT) but who haven't yet received chemotherapy for mCRPC.

SPLASH Patient Summary

The purpose of this trial is to evaluate the efficacy and safety of 177Lu-PNT2002 in patients with mCRPC who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT), such as Abiraterone or Enzalutamide, but who haven't yet received chemotherapy for mCRPC.

During the trial, all participants will be treated with either 177Lu-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 177Lu-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 177Lu-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 patients in the future.

What type of therapy is being studied?

177Lu-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 two parts: a radioisotope, which emits therapeutic radiation to kill nearby cells, and a ligand, which can direct the drug to a specific target, like the PSMA target expressed by Prostate Cancer cells in the case of 177Lu-PNT2002.

Who can participate?

Participation in this clinical trial is determined using eligibility criteria. Some key eligibility criteria are provided below.

You may be able to participate if:

  • Aged 18 years or older, with documented progressive mCRPC
  • Previous treatment with only one ARAT and ineligible or refuse chemotherapy
  • Positive PSMA PET scan
  • Adequate organ function
  • ECOG Score of 0 – 1

You may not be able to participate if:

  • Received previous chemotherapy for CRPC (chemotherapy for HSPC is permitted)
  • Prior treatment with radionuclides, immune-therapy or PSMA-targeted RLT
  • Progressed on two or more lines of ARATs
  • Use of opioids for cancer-related pain ≤ 30 days prior to consent

Possible Benefits:

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

Possible Risks:

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

Clinical Trial Sites:

This is a Phase 3 trial that will enroll 415 patients across the United States. The trial began February 2021 and is scheduled to be completed by March 2023. A full listing of trial sites can be found here.

Organization: POINT Biopharma



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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