PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE

Study Overview
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Brief Summary
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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
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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: In negative 68Ga-PSMA PET/CT or positive findings within prostate bed: Prostate bed RT 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. 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 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.

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

Conditions
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Prostate Cancer, Biochemical Relapse Fo Malignant Neoplasm of Prostate, Prostate Adenocarcinoma, Prostate Cancer Recurrent

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients affected by biochemical relapse after radical prostatectomy undergoing staging PSMA-PET/CT and baseline blood sample for miRNA panel assessment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | 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. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | Time between end of tailored treatment after 68Ga-PSMA PET/CT and death. | 2 years | 
| Cause-specific survival | Time between end of tailored treatment and death for prostate Cancer. | 2 years | 
| Radiological Progression Free Survival | 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. | 2 years | 
| Quality of Life | 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)-C30 | 2 years | 
| Quality of Life | 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 | 2 years | 
| Management Change | Assess the proportion of management changes induced by positive PSMA PET/CT results. | 2 years | 
| Association between PSMA PET/CT Detection Rate and specific miRNA panel | Association between PSMA PET/CT Detection Rate and specific miRNA panel | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PSMA, 68Ga-PSMA PET/CT, PET/CT, Biochemical Relapse, micro-RNA, SBRT, Radiotherapy