PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE

Recruiting

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

• Registration Number: NCT05022914
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

Brief 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.

Study Timeline

• Study Start: 2021-01-19
• Status Verified: 2021-08
• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-24
• Last Update Submitted: 2021-08-24
• Study First Posted: 2021-08-26
• Last Update Posted: 2021-08-26
• Primary Completion: 2024-01-19
• Study Completion: 2027-01-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 180

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival	2 year	PFS is defined as time from end of salvage treatment performed at first relapse to documented biochemical progression or radiological progression (or both), death from any cause or censoring at date of last follow-up.

Secondary Outcome Measures

Name	Time	Method
Cause-specific survival	2 years	Time between end of tailored treatment and death for prostate Cancer.
Overall Survival	2 years	Time between end of tailored treatment after 68Ga-PSMA PET/CT and death.
Radiological Progression Free Survival	2 years	The occurrence of any new lesion detectable with PSMA. PET/CT and/or any other molecular/radiological exam, which will be performed in case of biochemical or clinical progression.
Management Change	2 years	Assess the proportion of management changes induced by positive PSMA PET/CT results.
Association between PSMA PET/CT Detection Rate and specific miRNA panel	2 year	Association between PSMA PET/CT Detection Rate and specific miRNA panel
Quality of Life	2 years	Record rate of patients with impaired quality of life measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-PR25

Trial Locations

Locations (1)

AOU Careggi Radiation Oncology Unit; 🇮🇹 Florence, Italy