Prostate Cancer Clinical Trial
Official title:
PSMA Radio-Guided Lymph Node Dissection With Beta-Probe, in High-risk Prostate Cancer Patients.
NCT number | NCT05596851 |
Other study ID # | IEO 1703 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 21, 2022 |
Est. completion date | December 1, 2023 |
The goal of this observational study is to evaluate the diagnostic efficacy and the safety of the combined approach with β-probe and 68Ga-PSMA-11 PET/CT in the correct identification of lymph node metastases, in high-risk prostate cancer patients undergoing radical prostatectomy and pelvic lymph node dissection.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | December 1, 2023 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically proven prostate cancer - High-risk prostate cancer (T>T2c and/or PSA>20 and/or ISUP>3) - Patients suitable for radical prostatectomy + pelvic lymph node dissection - 68Ga-PSMA-11 PET/CT performed within 4 weeks prior to surgery - PSMA positive pelvic lymph nodes detected at 68Ga-PSMA-11 PET/CT - Age >18 years old - Willing to sign informed consent Exclusion Criteria: - Patient unfit for surgery - M1 stage (any M) detected at 68Ga-PSMA-11 PET/CT or other imaging modalities performed during diagnostic wok-up evaluation - Unable to tolerate PET scan |
Country | Name | City | State |
---|---|---|---|
Italy | IEO European Institute of Oncology | Milan |
Lead Sponsor | Collaborator |
---|---|
European Institute of Oncology |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity, specificity and positive predictive value in a per-region analysis | March 2022 - March 2023 | ||
Secondary | Comparison of ß-probe intra-operatory measurements with ex-vivo ones. | March 2022 - March 2023 | ||
Secondary | Comparison of ß-probe measurements and 68Ga-PSMA-11 semi-quantitative parameters | SUVmax and PSMA-TV will be evaluated as semi-quantitative parameters | March 2022 - March 2023 | |
Secondary | Comparison of ß-probe measurements and PSMA expression assessed by immunohistochemical analysis (IHC). | IHC will be evaluated by PSMA staining on the surgical specimens. | May 2022 - December 2023 |
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