PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE

Azienda Ospedaliero-Universitaria Careggi

Status: Enrolling

Conditions: Prostate Adenocarcinoma; Prostate Cancer Recurrent; Prostate Cancer; Biochemical Relapse Fo Malignant Neoplasm of Prostate

Study type: Observational

Funder types: Other

Identifiers

NCT05022914

PSICHE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent
• Age >18
• Patient suitable for 68Ga-PSMA PET/CT re-staging according to clinical practice (Previous radical prostatectomy with histological result of Prostate adenocarcinoma +/- postoperative prostate bed radiotherapy (adjuvant or salvage setting), with a biochemical relapse defined as a PSA > 0.2 and <1

Exclusion criteria

• ADT administration within 6 months from study enrollment
• Persistent elevation of PSA after RP measured within 16 weeks from surgery (> 0.1 ng/ml)

Trial design

180 participants in 1 patient group

1

Description:

Patients affected by biochemical relapse after radical prostatectomy undergoing staging PSMA-PET/CT and baseline blood sample for miRNA panel assessment.