PredicTive value of FluoR-18 PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT before PLND for lymph nodE staging in primary pRostate cancer - TRACER

Catharina Hospital Eindhoven0 sites70 target enrollmentSeptember 7, 2020

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prostate cancer (PCa) is the most common malignancy amongst men in Westerncountries. In order to select the most suitable treatment for patients diagnosed with PCa, it is importantto stage accurately. Both 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT are currently mostly used to detectrecurrence in treated PCa, while the diagnostic value in detecting lymph node metastasis in primaryprostate cancer is not yet clear.
Sponsor: Catharina Hospital Eindhoven
Enrollment: 70
Status: Active, not recruiting
Last Updated: 5 years ago

No summary available.

Registry

who.int

Start Date

September 7, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

Catharina Hospital Eindhoven

•1\. Biopsy proven adenocarcinoma of the prostate;
•2\. Indication for (super)extended PLND (with or without (robot\-assisted) laparoscopic prostatectomy), in intermediate and high risk patients ( d’Ámico score) with an MSKCC \>5% lymph node prediction;
•3\. Mentally competent and understanding of benefits and potential burden of the study;
•4\. Written informed consent;
•5\. Age \=18 years.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 35
•F.1\.3 Elderly (\>\=65 years) yes

•1\. History of prior diagnosed or treated PCa.
•2\. Known concomitant malignancies (except Basal Cell Carcinoma of the skin).
•3\. Unwillingness or inability to undergo 18F\-PSMA\-1007 PET/CT and anti\-3\-\[18F] FACBC PET/CT, in combination with PLND.
•4\. Metastasis beyond pelvic region and/or bone metastasis. Patients with bone metastasis will not get a PLND, but will be included in the study for further follow\-up.