PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE — PSICHE  

Prostate Cancer Clinical Trial

Official title: Prostate-Specific Membrane Antigen (PSMA) Guided Approach for bIoCHEmical Relapse After Prostatectomy- A Prospective Observational Study-PSICHE

Status Recruiting

Clinical Trial Summary

This observational study was designed to evaluate progression free survival after PSMA-PET/CT based salvage approach for patients affected by biochemical relapse after radical prostatectomy.

Clinical Trial Description

This is a prospective observational multicenter study including patients treated with upfront radical prostatectomy +/- postoperative prostate bed radiotherapy, with histological result of Prostate adenocarcinoma, affected by biochemical relapse (defined as PSA>/= 0.2 ng/ml) with a PSA at recurrence </=1 ng/ml. Patients will be staged with centralized 68 Ga- PSMA PET/CT and treated with a pre-defined approach based on 68 Ga-PSMA PET/CT findings.

The predefined approach will consist in the following flowchart:

1. In negative 68Ga-PSMA PET/CT or positive findings within prostate bed: Prostate bed RT

2. In 68Ga-PSMA PET/CT detecting pelvic nodal recurrence amenable with stereotactic body radiation therapy (SBRT) on all sites of disease: SBRT to all positive nodal disease.

3. In abdominal nodal or bone oligometastatic disease amenable with stereotactic body radiation therapy (SBRT) on all sites of disease: SBRT on all sites of disease

4. In abdominal nodal or bone metastatic disease (>3 lesions or non-amenable with SBRT) and/or visceral disease: ADT+/-other systemic therapies available for metastatic hormone sensitive pCa at physician discretion. ;

Related Conditions & MeSH terms

• Neoplasms
• Prostate Adenocarcinoma
• Prostate Cancer
• Prostate Cancer Recurrent
• Prostatic Neoplasms
• Recurrence

• NCT number: NCT05022914
• Study type: Observational
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: Lorenzo Livi, Prof.
• Phone: +390557947264
• Email: lorenzo.livi@unifi.it
• Status: Recruiting
• Start date: January 19, 2021
• Completion date: January 19, 2027