PSMA guided approach for bIoCHEmical relapse after prostatectomy‐ (PSICHE) trial (NCT05022914). Detection rate and treatment decision after 68Ga‐PSMA PET/CT within a prospective study

Author:

Francolini Giulio1,Banini Marco2,Di Cataldo Vanessa1,Detti Beatrice1ORCID,Caini Saverio3,Loi Mauro1ORCID,Simontacchi Gabriele1,Desideri Isacco2,Greto Daniela1,Valzano Marianna2,Roghi Manuele2,Serni Sergio4,Vaggelli Luca5,Salvestrini Viola2,Visani Luca2,Becherini Carlotta1,Olmetto Emanuela1,Franzese Ciro6,Baldaccini Davide6,Scorsetti Marta6,Sollini Martina7,Chiti Arturo8,Meattini Icro2,Valicenti Richard K.9,Livi Lorenzo2

Affiliation:

1. Radiation Oncology Unit Azienda Ospedaliero‐Universitaria Careggi Florence Italy

2. Department of Biomedical, Experimental and Clinical Sciences “Mario Serio” University of Florence Florence Italy

3. Cancer Risk Factors and Lifestyle Epidemiology Unit Institute for Cancer Research, Prevention and Clinical Network (ISPRO) Florence Italy

4. Unit of Urological Robotic Surgery and Renal Transplantation and Department of Experimental and Clinical Medicine University of Florence, Careggi Hospital Florence Italy

5. Nuclear Medicine Division Careggi University Hospital Florence Italy

6. Radiotherapy and Radiosurgery Department Humanitas Clinical and Research Center, IRCSS Milan‐Rozzano Italy

7. Department of Biomedical Sciences and Department of Biomedical Sciences Humanitas University Milan Italy

8. Nuclear Medicine Department IRCCS San Raffaele Milan Italy

9. Department of Radiation Oncology UC Davis Davis California USA

Abstract

AbstractBackgroundUltrasensitive imaging has been demonstrated to influence biochemical relapse treatment. PSICHE is a multicentric prospective study, aimed at exploring detection rate with 68Ga‐PSMA‐11 positron emission tomography/computed tomography (PET/CT) and outcomes with a predefined treatment algorithm tailored to the imaging.MethodsPatients affected by biochemical recurrence after surgery (prostate specific antigen [PSA] > 0.2 < 1 ng/mL) underwent staging with 68Ga‐PSMA PET/CT. Management followed this treatment algorithm accordingly with PSMA results: prostate bed salvage radiotherapy (SRT) if negative or positive within prostate bed, stereotactic body radiotherapy (SBRT) if pelvic nodal recurrences or oligometastatic disease, androgen deprivation therapy (ADT) if nonoligometastatic disease. Chi‐square test was used to evaluate the relationship between baseline features and rate of positive PSMA PET/CT.ResultsOne hundred patients were enrolled. PSMA results were negative/positive in the prostate bed in 72 patients, pelvic nodal or extrapelvic metastatic disease were detected in 23 and 5 patients. Twenty‐one patients underwent observation because of prior postoperative radiotherapy (RT)/treatment refusal. Fifty patients were treated with prostate bed SRT, 23 patients underwent SBRT to pelvic nodal disease, five patients were treated with SBRT to oligometastatic disease. One patient underwent ADT. NCCN high‐risk features, stage > pT3 and ISUP score >3 reported a significantly higher rate of positive PSMA PET/CT after restaging (p = 0.01, p = 0.02, and p = 0.002). By quartiles of PSA, rate of positive PSMA PET/CT was 26.9% (>0.2; <0.29 ng/mL), 24% (>0.3; <0.37 ng/mL), 26.9% (>0.38; <0.51 ng/mL), and 34.7% (>0. 52; <0.98 ng/mL).ConclusionsPSICHE trial constitute a useful platform to collect data within a clinical framework where modern imaging and metastasis‐directed therapy are integrated.

Publisher

Wiley

Subject

Urology,Oncology

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