Table of Contents
- Clinical trial overview
- Individual studies
- Who can join these trials
- What the trials measure
- Key trial terms
Clinical trial overview
These studies are testing 5,8-Dichloro-2-[(4-Methoxy-6-Methyl-2-Oxo-1,2-Dihydropyridin-3-Yl)Methyl]-7-[(R)-Methoxy(Oxetan-3-Yl)Methyl]-3,4-Dihydroisoquinolin-1(2H)-One in men with advanced prostate cancer.[1] The trials are all Phase 3 studies, which means they compare treatments in larger groups of people to see which option works better.[1] The main goal across the studies is to see whether the study medicine helps delay cancer progression, especially when used with enzalutamide.[1][2][3]
Individual studies
NCT06551324 is a Phase 3 study in men with metastatic castration-resistant prostate cancer who were previously treated with abiraterone acetate.[1] It plans to enroll 600 participants and is designed to show whether 5,8-Dichloro-2-[(4-Methoxy-6-Methyl-2-Oxo-1,2-Dihydropyridin-3-Yl)Methyl]-7-[(R)-Methoxy(Oxetan-3-Yl)Methyl]-3,4-Dihydroisoquinolin-1(2H)-One plus enzalutamide is better than enzalutamide alone or docetaxel for delaying radiologic progression-free survival.[1]
NCT06629779 is another Phase 3 study in metastatic castration-resistant prostate cancer, but in men who have not tried novel hormonal therapy or chemotherapy for metastatic disease.[2] It plans to enroll 900 participants and compares the study medicine plus enzalutamide with placebo plus enzalutamide.[2]
NCT07028853 is a Phase 3 study in metastatic castration-sensitive prostate cancer in men who have not tried novel hormonal therapy or chemotherapy for metastatic disease.[3] It plans to enroll 1341 participants and compares mevrometostat, which is the name used in the trial for PF-06821497, plus enzalutamide with placebo plus enzalutamide.[3]
Who can join these trials
These trials are for men with prostate cancer that has spread to other parts of the body.[1][2][3] One group includes men with metastatic castration-resistant disease who already received abiraterone acetate.[1] Two studies include men who have not yet had novel hormonal therapy or chemotherapy for metastatic prostate cancer.[2][3] This means the trials are looking at different stages of treatment history, not just one type of patient.[1][2][3]
What the trials measure
The main endpoint in all three studies is rPFS, or radiologic progression-free survival.[1][2][3] This is measured by BICR, which means blinded independent central review, so scan results are checked by reviewers who do not know which treatment a person received.[1][2][3] The trials use RECIST v1.1 for soft tissue disease and PCWG3 for bone disease, which are standard ways to judge whether the cancer is growing or spreading.[1][2][3]
Key trial terms
Enzalutamide is the comparison treatment used in all three studies, and in one trial it is compared against docetaxel as well.[1][2][3] One study also uses placebo tablets that match the study medicine, so the treatment groups can be compared fairly.[2][3] The word authorised in the status field means the trial has been approved to move forward.[1][2][3]
