Early biochemical outcomes following PSMA guided approach for bIoCHEmical relapse after prostatectomy-PSICHE trial (NCT05022914): preliminary results

Clin Exp Metastasis. 2023 Apr;40(2):197-201. doi: 10.1007/s10585-023-10204-y. Epub 2023 Apr 3.

Abstract

PSICHE (NCT05022914) is a prospective trial to test a [68Ga]Ga- PSMA-11 PET/CT imaging tailored strategy. All evaluable patients had biochemical relapse after surgery and underwent centralized [68Ga]Ga-PSMA-11 PET/CT imaging. The treatment was performed according pre-defined criteria. Observation and re-staging at further PSA progression were proposed to patients with negative PSMA and previous postoperative RT. Prostate bed SRT was proposed to all patients with a negative staging or positive imaging within prostate bed. Stereotactic body radiotherapy (SBRT) to all sites of disease was used for all patients with pelvic nodal recurrence (nodal disease < 2 cm under aortic bifurcation) or oligometastatic disease. At 3 months after treatment, 54.7% of patients had a complete biochemical response Only 2 patients experienced G2 Genitourinary toxicity. No G2 Gastrointestinal toxicity was recorded. A PSMA targeted treatment strategy led to encouraging results and was well tolerated.

Keywords: Bladder; Kidney; Prostate; Radiotherapy.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Gallium Isotopes
  • Gallium Radioisotopes*
  • Humans
  • Male
  • Neoplasm Recurrence, Local / pathology
  • Neoplasm Recurrence, Local / radiotherapy
  • Neoplasm Recurrence, Local / surgery
  • Positron Emission Tomography Computed Tomography / methods
  • Prospective Studies
  • Prostate-Specific Antigen
  • Prostatectomy
  • Prostatic Neoplasms* / pathology
  • Prostatic Neoplasms* / radiotherapy
  • Prostatic Neoplasms* / surgery

Substances

  • Gallium Radioisotopes
  • Gallium Isotopes
  • Prostate-Specific Antigen