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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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05022914
Study type Observational
Source Azienda Ospedaliero-Universitaria Careggi
Contact Lorenzo Livi, Prof.
Phone +390557947264
Email [email protected]
Status Recruiting
Start date January 19, 2021
Completion date January 19, 2027

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