PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE

Launched by AZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI · Aug 24, 2021

Keywords

ClinConnect Summary

The PSICHE trial is studying how well a specific imaging test called PSMA-PET/CT can help guide treatment for men who have experienced a biochemical relapse after surgery for prostate cancer. A biochemical relapse means that after surgery, a blood test shows a rise in prostate-specific antigen (PSA), which suggests that cancer may still be present. This study aims to see how long patients can live without the cancer getting worse after receiving treatment based on the results of this imaging test.

To be eligible for the trial, participants must be men over the age of 18 who have had prostate surgery and have a PSA level between 0.2 and 1.0. They should not have received certain hormone treatments recently or have a very high PSA level shortly after surgery. Those who join the study will undergo the PSMA-PET/CT scan and will be monitored over time to see how their condition progresses. This trial is currently recruiting participants, and it aims to provide valuable information on improving care for men facing this situation.

Gender

MALE

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)