About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 population
Patient affected by biochemical recurrence after radical prostatectomy.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Overall Survival
Time between end of tailored treatment after 68Ga-PSMA PET/CT and death.
Cause-specific survival
Time between end of tailored treatment and death for prostate Cancer.
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.
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
Sponsors and contacts
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