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.
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 Type
OBSERVATIONAL
Enrollment
180
AOU Careggi Radiation Oncology Unit
Florence, Italy
RECRUITINGProgression 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.
Time frame: 2 year
Overall Survival
Time between end of tailored treatment after 68Ga-PSMA PET/CT and death.
Time frame: 2 years
Cause-specific survival
Time between end of tailored treatment and death for prostate Cancer.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 2 years
Management Change
Assess the proportion of management changes induced by positive PSMA PET/CT results.
Time frame: 2 years
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Association between PSMA PET/CT Detection Rate and specific miRNA panel
Association between PSMA PET/CT Detection Rate and specific miRNA panel
Time frame: 2 year