PSMA vs FACBC compared to PLND for lymph node staging in primary prostate cancer

Phase 1

• 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.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2019-004045-33-NL
• Lead Sponsor: Catharina Hospital Eindhoven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-07
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 70

Inclusion Criteria

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
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified