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. 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?
Complete criteria available online at clinicaltrials.gov under NCT04647526 . Possible Benefits:
Possible Risks:
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. Go Back |
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