(UroToday.com) The 2024 European Association of Urology (EAU) annual congress held in Paris, France between April 5th and 8th was host to an abstract session on treatment intensification to improve prostate cancer outcomes. Dr. Giulio Francolini presented the results of the PSICHE trial, a prospective trial evaluating a prostate-specific membrane antigen (PSMA)-guided approach for the management of biochemical relapse following radical prostatectomy.
Salvage radiotherapy remains a standard of care approach for the management of patients with biochemical relapse following radical prostatectomy. PSMA-PET/CT is increasingly used in this setting, owing to its improved performance characteristics,1 and has been demonstrated to significantly alter treatment decision making in this setting.2,3 PSICHE (NCT05022914) is a prospective multicenter trial aimed at evaluating a PSMA-PET-tailored strategy in this setting.
This trial included patients with biochemical recurrence following radical prostatectomy +/- post-operative radiotherapy, with PSA levels between 0.2 and 1 ng/ml. All patients underwent staging with 68Ga-PSMA PET/CT. Patients were managed as follows, based on imaging results:
- Negative PSMA PET/CT or prostate fossa-limited disease Prostate bed salvage radiotherapy
- Pelvic nodal recurrences or oligometastatic disease Stereotactic body radiotherapy (SBRT)
- Polymetastatic disease Androgen deprivation therapy (ADT)
Observation was proposed in all patients in whom PSMA PET/CT was negative and postoperative radiotherapy had already been performed. The chi-square test was used to evaluate the association between baseline features and the proportion of positive PSMA PET/CT scans.
This study included 174 patients. PSMA PET/CT results were as follows:
- Negative PSMA PET/CT or prostate fossa-limited disease: 69.5%
- Pelvic nodal recurrences: 22.4%
- Oligometastatic disease: 5.7%
- Polymetastatic disease: 2.3%
Consequently, the recommended management was as follows:
- Salvage radiotherapy: 59.8%
- SBRT: 28.2%
- Observation: 8.6%
- Immediate ADT: 2.3%
- Re-treatment: 1.1%
After a median follow up of 17 months, further biochemical progression following treatment was observed in 50 cases, with 27 patients demonstrating PSMA-detected interval distant metastases. 13 patients were started ADT. The median biochemical relapse-free survival was 25 months (95% CI: 20 – 63 months), while metastases-free and ADT-free survivals were not reached.
The investigators concluded that a PSMA-adapted treatment strategy leads to promising results within the setting of a prospective multicenter trial. The majority of patients remained free from ADT with this approach, avoiding unnecessary treatment toxicity.
Presented by: Giulio Francolini, MD, Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence, Florence, Italy
Written by: Rashid Sayyid, MD, MSc - Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2024 European Association of Urology (EAU) annual congress, Paris, France, April 5th - April 8th, 2024
References:- Hofman MS, Lawrentschuk N, Francis, RJ, et al. Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (proPSMA): A prospective, randomized, multicentre study. Lancet 2020 Apr 11;395(10231):1208-1216.
- Morris MJ, Rowe SP, Gorin MA, et al. Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase III, Multicenter Study. Clin Cancer Res. 2021 Jul 1;27(13):3674-3682.
- Pienta KJ, Gorin MA, Rowe SP, et al. A Phase 2/3 Prospective Multicenter Study of the Diagnostic Accuracy of Prostate Specific Membrane Antigen PET/CT with 18F-DCFPyL in Prostate Cancer Patients (OSPREY). J Urol. 2021 Jul;206(1):52-61.