A Phase 2 Trial of Combined Lutetium-PSMA Theranostics and Docetaxel in Newly Diagnosed Metastatic Hormone-Naive Prostate Cancer
Abstract
This research will conduct a randomized phase II multi-centers trial of 177Lu-PSMA + ADT followed by standard-of-care docetaxel in comparison to standard-of-care alone (ADT docetaxel) will be conducted. We postulate that the addition of up-front treatment with 177Lu-PSMA will more effectively eradicate disease resulting in a higher proportion of patients with undetectable PSA at 12 months. This is an open label, randomized, and stratified, 2-Arm, multi-centre, phase 2 clinical trial recruiting 140 patients at 11 Australian centers. Patients with de novo high-volume metastatic hormone-nave prostate cancer will be randomized to the experimental Arm (177Lu-PSMA followed by docetaxel) or standard-of-care Arm (docetaxel alone) in a 1:1 ratio. The primary objective is to compare the undetectable prostate specific antigen (PSA) rate at 12 months after commencement of protocol therapy in male patients with newly-diagnosed high-volume metastatic hormone-nave prostate cancer (mHNPC) treated with sequential 177Lu-PSMA and docetaxel versus those treated with docetaxel alone. Progress: This is an active RCT. Currently open at 10 sites across Australia. Almost at 50% target recruitment.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 01, 2021
- Accession Number
- AD1154865
Entities
People
- Michael S Hofman
Organizations
- University of Melbourne