The PRONOUNCED trial is a prospective open-label study of 50 patients to evaluate the safety and clinical impact of 68Ga THP-PSMA PET/CT imaging (THP-PSMA) on patient management and treatment decisions in men who are newly diagnosed or have biochemically recurrent prostate cancer after initial treatment.
The study met its primary and secondary endpoints. Data demonstrates that post THP-PSMA scan, one third of newly diagnosed prostate cancer patients, and over 50% of patients with biochemically recurrent disease including 75% in a post-radical radiotherapy setting, saw their treatment plan altered to be more appropriate as a result of re-staging their prostate cancer. The safety data showed that THP-PSMA was well tolerated with no serious adverse events reported and was therefore considered safe.
"The PRONOUNCED study was completed with a substantial number of changes to the treatment regime made following the THP-PSMA scan and shows how this exciting technology can influence the management of prostate cancer patients," said Professor Jamshed Bomanji, co-investigator and head of department at the Institute of Nuclear Medicine, UCLH. "The new THP-PSMA PET/CT imaging allows for prospective analysis of the clinical disease status rather than retrospective, allowing for better informed decision making."
Greg Mullen, PhD., CEO of Theragnostics added, "We are very pleased that the PRONOUNCED trial has completed with such a positive result, this combined with a positive meeting with the FDA earlier this year on our route to NDA submission are key milestones in bringing THP-PSMA to patients. We are convinced that a THP-PSMA scan will benefit the treatment of prostate cancer patients by better informed and faster decision making. We look forward to sharing these data with the medical community at upcoming scientific congresses and in peer-reviewed publications."The trial is jointly funded by Innovate UK and Theragnostics and conducted at University College London Hospitals NHS Foundation Trust (UCLH) with multiple referral sites in the UK including Guys and St. Thomas' NHS Foundation Trust (GSTT), Barts Health NHS Trust, Royal Free London NHS Foundation Trust. The study was led by Dr. Asim Afaq, UCLH Consultant Radiologist at the Institute of Nuclear Medicine, together with UCLH uro-oncology colleagues including Professor Heather Payne, Dr. Reena Davda, Mr. John Hines, and Prof Gary Cook, Professor of Clinical PET imaging at King's College London and GSTT.
The study was completed with support from the National Institute for Health Research University College London Hospitals Biomedical Research Centre and the Cancer Research UK University College London Experimental Cancer Medicine Centre.
About the PRONOUNCED Trial
The PRONOUNCED trial, "68Ga THP-PSMA PET/CT Imaging in High Risk Primary Prostate Cancer or Biochemical Recurrence of Prostate Cancer (PRONOUNCED)," was an open-label study in the UK designed to assess the clinical utility of THP-PSMA scan in the management of patients with primary prostate cancer or with biochemical recurrence of prostate cancer after initial treatment. The primary endpoint evaluated the clinical impact of PSMA (68Ga) scan on treatment decisions, assessed by comparing records of the patient's treatment plan after a THP-PSMA scan with the treatment plan prior to the scan. Secondary endpoints included evaluation of the effect of treatment change in patients with positive THP-PSMA scan findings who had a treatment change involving radical salvage therapy; diagnostic performance; PSA threshold; safety assessment and comparison with standard of care imaging (if performed). Follow up of the efficacy and safety of THP-PSMA scan on impacting patient management decisions is ongoing. Theragnostics plans to present results of the PRONOUNCED trial at an upcoming medical congress and subsequently publish full results in a peer-reviewed publication.
Source: Prnewswire.co.uk. (2019). Theragnostics Reports Positive Clinical Trial Results from Prostate Cancer Study. [online] Available at: https://www.prnewswire.co.uk/news-releases/theragnostics-reports-positive-clinical-trial-results-from-prostate-cancer-study-821771331.html [Accessed 3 Oct. 2019].