Pairing New Dosing Schedules to Improve Life for Advanced Prostate Cancer Patients

Recruiting · Phase 3 · Metastatic Castration-Resistant Prostate Carcinoma and related conditions · 19 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This study looks at how different dosing schedules of the drug Lutetium 177Lu PSMA RLT might help men with advanced prostate cancer. It aims to see if giving the drug less often can improve the quality of life without affecting how long patients live. The trial focuses on men whose prostate cancer no longer responds to hormone therapy and may have spread to other parts of the body.

This is a Phase 3 trial, which means it is looking at how well the treatment works and its safety. The trial hopes to include about 1,524 participants. The trial is not currently regulated by the FDA.

Who can join

Men aged 18 and older can join this trial. Participants must have confirmed prostate cancer and specific results from imaging tests like PET scans. They should have progressive disease and have received certain prior treatments. The trial team will check if each person meets these requirements before they can join.

Conditions

Metastatic Castration-Resistant Prostate Carcinoma, Metastatic Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8

Age group

Adult, Older adult

Sex

Male

The study team makes the final call on eligibility.

What happens in the study

Participants will receive Lutetium 177Lu PSMA RLT either every 6 weeks or on an adaptive schedule based on their PSA levels. They will also have blood tests, CT scans, and bone scans during the study. Some may receive an MRI based on their medical history. Everyone will be monitored closely for their response to treatment.