A Phase 2 Trial of Combined Lutetium-PSMA Theranostics and Docetaxel in Newly Diagnosed Metastatic Hormonenaive Prostate Cancer
Abstract
This research will conduct a randomised phase II multi-centre 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, randomised, and stratified, 2-Arm, multi-centre, phase 2 clinical trial recruiting 140 patients at 11 Australian centres. Patients with de novo high-volume metastatic hormone-nave prostate cancer will be randomised 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-naive prostate cancer (mHNPC) treated with sequential 177Lu-PSMA and docetaxel versus those treated with docetaxel alone. Progress: the clinical trials protocol has been written. This has been submitted to and approved by the sponsorship committee of the Peter MacCallum Cancer Centre. This has subsequently been submitted to the clinical governance and ethics committee and is currently being reviewed.
Document Details
- Document Type
- Technical Report
- Publication Date
- Sep 01, 2020
- Accession Number
- AD1114593
Entities
People
- Michael S Hofman
Organizations
- University of Melbourne