The diagnostic value of FAPI PET/CT in staging of newly diagnosed PCa
- Conditions
- Prostate cancer10038597
- Registration Number
- NL-OMON53628
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Male, aged >= 18 years;
- WHO performance status 0, 1 or 2;
- Written informed consent;
- Biopsy-proven newly diagnosed PCa;
- International Society of Urological Pathology (ISUP) grade group (GG) >= 3
and/or PSA >= 20 ng/ml and/or >=cT3a.
If all of the criteria above are met, a subject must also meet all of the
following subgroup specific criteria:
Group 1 (n=15):
- PSMA PET/CT with PSMA-avid primary tumor with PSMA-avid loco-regional and/or
distant metastases.
Group 2 (n=15):
- PSMA PET/CT with PSMA-avid primary tumor with no PSMA-avid loco-regional or
distant metastases;
- Increased risk of nodal metastases according to the Briganti 2019 nomogram
(Briganti >=40%)
- Scheduled for (laparoscopic) prostatectomy including ePLND.
- Known second malignant disease that may complicate image interpretation.
- Inability to cooperate with the scan process: inability to lie relatively
still and in supine for 30-60 minutes or patient body habitus above scanner
dimensions.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The added diagnostic value of FAPI PET/CT, relative to PSMA PET/CT, in staging<br /><br>of newly diagnosed PCa. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints: the diagnostic accuracy of FAPI PET/CT by correlating FAPI<br /><br>PET/CT findings to clinical follow-up and histopathological and/or laboratory<br /><br>findings.</p><br>