Trials / Recruiting

RecruitingNCT05022914

PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE

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

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 180 (estimated)

Sponsor: Azienda Ospedaliero-Universitaria Careggi · Academic / Other
Sex: Male
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

Timeline

Start date: 2021-01-19
Primary completion: 2024-01-19
Completion: 2027-01-19
First posted: 2021-08-26
Last updated: 2021-08-26

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05022914. Inclusion in this directory is not an endorsement.