Clinical trial NCT05022914: PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE
Official title: Prostate-Specific Membrane Antigen (PSMA) Guided Approach for bIoCHEmical Relapse After Prostatectomy- A Prospective Observational Study-PSICHE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Biochemical Relapse Fo Malignant Neoplasm of Prostate
Prostate Adenocarcinoma
Prostate Cancer Recurrent
Keywords: PSMA
68Ga-PSMA PET/CT
PET/CT
Biochemical Relapse
micro-RNA
SBRT
Radiotherapy
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient affected by biochemical recurrence after radical prostatectomy.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Progression free survival
timeFrame: 2 year
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
measure: Cause-specific survival
timeFrame: 2 years
measure: Radiological Progression Free Survival
timeFrame: 2 years
measure: Quality of Life
timeFrame: 2 years
measure: Quality of Life
timeFrame: 2 years
measure: Management Change
timeFrame: 2 years
measure: Association between PSMA PET/CT Detection Rate and specific miRNA panel
timeFrame: 2 year
Other outcomes:
Locations:
city: Florence
country: Italy
facility: AOU Careggi Radiation Oncology Unit
Study officials:
affiliation: Azienda Ospedaliero-Universitaria Careggi
name: Lorenzo Livi, Prof.
role: PRINCIPAL_INVESTIGATOR
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