In short
Clinical trials are investigating 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. The studies are checking whether it can help delay cancer growth and how it compares with current treatments. All listed trials are Phase 3 studies in prostate cancer populations.
Key points
- Clinical trials of 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 are being done in men with advanced prostate cancer. The studies include metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer. All listed trials are Phase 3 studies, which means they compare treatments in larger groups of patients. The main goal is to see whether the study medicine can delay cancer growth better than the comparison treatment. The key outcome is radiologic progression-free survival, or rPFS, measured by scan review. The trials include men who have already had some treatments and men who have not yet had novel hormonal therapy or chemotherapy for metastatic disease.
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. The trials are all Phase 3 studies, which means they compare treatments in larger groups of people to see which option works better. The main goal across the studies is to see whether the study medicine helps delay cancer progression, especially when used with enzalutamide.
Individual studies
NCT06551324 is a Phase 3 study in men with metastatic castration-resistant prostate cancer who were previously treated with abiraterone acetate. 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.
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. It plans to enroll 900 participants and compares the study medicine plus enzalutamide with placebo plus enzalutamide.
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. 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.
Who can join these trials
These trials are for men with prostate cancer that has spread to other parts of the body. One group includes men with metastatic castration-resistant disease who already received abiraterone acetate. Two studies include men who have not yet had novel hormonal therapy or chemotherapy for metastatic prostate cancer. This means the trials are looking at different stages of treatment history, not just one type of patient.
What the trials measure
The main endpoint in all three studies is rPFS, or radiologic progression-free survival. 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. 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.
Key trial terms
Enzalutamide is the comparison treatment used in all three studies, and in one trial it is compared against docetaxel as well. One study also uses placebo tablets that match the study medicine, so the treatment groups can be compared fairly. The word authorised in the status field means the trial has been approved to move forward.