AcTFirstAAA817 and ARPI for PSMA-positive Metastatic Castration Resistant Prostate Cancer
AAA817
+ ARPI
+ Standard of Care
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Diagnostic Study
Summary
Study start date: July 1, 2025
Actual date on which the first participant was enrolled.This study is designed to see if a new treatment called 225Ac-PSMA-617, when combined with either enzalutamide or abiraterone, is more effective than the current standard treatments for adult men with a type of prostate cancer known as PSMA-positive metastatic castration-resistant prostate cancer. The main goal is to find out if this new treatment can help patients live longer without the cancer getting worse. This is important because finding more effective treatments can improve the quality of life and outcomes for patients who have few options due to the advanced stage of their cancer. Participants in the study will first undergo scans to confirm their eligibility and ensure their cancer is PSMA-positive. Those who qualify will be randomly assigned to receive either the new treatment of 225Ac-PSMA-617 through an IV infusion, potentially with oral ARPI medications, or the standard care treatment, which could involve other oral ARPI drugs or chemotherapy. The study will closely monitor the safety of the treatments and measure how long patients go without their cancer progressing. Supportive care, including therapies to reduce certain hormone levels, is available to all participants as needed. The study does not allow switching between treatment groups, and safety checks are a routine part of the process.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.940 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.From 18 to 100 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 50 locations
Miami Cancer Institute at Bapt
Miami, United StatesUniv Of Iowa Hospitals And Clinics
Iowa City, United StatesUniversity of Kansas Hospital
Kansas City, United States