PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorAzienda Ospedaliero-Universitaria Careggi

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

180 Participants
are grouped into 1 trial group
Group A: 1

Trial outcomes

Primary outcomes

1

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.

Time frame
2 year

Secondary outcomes

1

Overall Survival

Time between end of tailored treatment after 68Ga-PSMA PET/CT and death.

Time frame
2 years
2

Cause-specific survival

Time between end of tailored treatment and death for prostate Cancer.

Time frame
2 years
3

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
4

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

Other outcomes

Sponsors and contacts

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