PSMA PET/CT guided intensification of therapy in patients at risk of advanced prostate cancer (PATRON): a pragmatic phase III randomized controlled trial

• Published in: BMC cancer Vol. 22; no. 1; pp. 251 - 11
• Main Authors: Ménard, Cynthia, Young, Sympascho, Zukotynski, Katherine, Hamilton, Robert J., Bénard, François, Yip, Steven, McCabe, Christopher, Saad, Fred, Brundage, Michael, Nitulescu, Roy, Bauman, Glenn
• Format: Journal Article
• Language: English
• Published: London BioMed Central 08.03.2022; BioMed Central Ltd; BMC
• Subjects: Adult; Antigens, Neoplasm - metabolism; Biomedical and Life Sciences; Biomedicine; Canada; Cancer Research; Care and treatment; Clinical Trials, Phase III as Topic; Cost benefit analysis; Cost-effectiveness analysis; Diagnosis; Equivalence Trials as Topic; Failure free survival; Fluorine Radioisotopes; GPI-Linked Proteins - metabolism; Health Promotion and Disease Prevention; Humans; Immune system; Intention to Treat Analysis; Male; Medicine/Public Health; Methods; Neoplasm Proteins - metabolism; Neoplasm Recurrence, Local - diagnostic imaging; Neoplasm Recurrence, Local - metabolism; Neoplasm Recurrence, Local - therapy; Neoplasm Staging - methods; Oncology; Overall survival; PET imaging; Phase III clinical trial; Positron Emission Tomography Computed Tomography; Pragmatic Clinical Trials as Topic; Prospective Studies; Prostate cancer; Prostatectomy - methods; Prostatic Neoplasms - diagnostic imaging; Prostatic Neoplasms - metabolism; Prostatic Neoplasms - therapy; PSMA PET; Radiopharmaceuticals; Radiotherapy, Image-Guided - methods; Radiotherapy, Intensity-Modulated - methods; Randomized Controlled Trials as Topic; Risk factors; Study Protocol; Surgery, Computer-Assisted - methods; Surgical Oncology; Testing; Treatment Outcome; Canada; Cost-effectiveness analysis; Failure free survival; Phase III clinical trial; PSMA PET; Overall survival; Radiotherapy; Prostate cancer; Superiority
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-022-09283-z

Background Positron emission tomography targeting the prostate specific membrane antigen (PSMA PET/CT) has demonstrated unparalleled performance as a staging examination for prostate cancer resulting in substantial changes in management. However, the impact of altered management on patient outcomes is largely unknown. This study aims to assess the impact of intensified radiotherapy or surgery guided by PSMA PET/CT in patients at risk of advanced prostate cancer. Methods This pan-Canadian phase III randomized controlled trial will enroll 776 men with either untreated high risk prostate cancer (CAPRA score 6–10 or stage cN1) or biochemically recurrent prostate cancer post radical prostatectomy (PSA > 0.1 ng/mL). Patients will be randomized 1:1 to either receive conventional imaging or conventional plus PSMA PET imaging, with intensification of radiotherapy or surgery to newly identified disease sites. The primary endpoint is failure free survival at 5 years. Secondary endpoints include rates of adverse events, time to next-line therapy, as well as impact on health-related quality of life and cost effectiveness as measured by incremental cost per Quality Adjusted Life Years gained. Discussion This study will help create level 1 evidence needed to demonstrate whether or not intensification of radiotherapy or surgery based on PSMA PET findings improves outcomes of patients at risk of advanced prostate cancer in a manner that is cost-effective. Trial registration This trial was prospectively registered in ClinicalTrials.gov as NCT04557501 on September 21, 2020.