PSMA Guided Approach for bIoCHEmical Relapse After Prostatectomy-PSICHE

  • STATUS
    Recruiting
  • End date
    Jan 19, 2027
  • participants needed
    180
  • sponsor
    Azienda Ospedaliero-Universitaria Careggi
Updated on 5 September 2021

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.

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.

Details
Condition Prostate Disorders, Non-metastatic Prostate Cancer, Prostatic disorder, Prostate Cancer Recurrent, Prostate Cancer, Malignant neoplasm of prostate, Prostate Cancer, Early, Recurrent, Prostate Adenocarcinoma, Adenocarcinoma of the Prostate, prostate cancers, prostate carcinoma, Recurrent Prostate Cancer, Adenocarcinoma of Prostate
Clinical Study IdentifierNCT05022914
SponsorAzienda Ospedaliero-Universitaria Careggi
Last Modified on5 September 2021

Eligibility

Yes No Not Sure

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)
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