A two-step study into the 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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27349

Enrollment

Registered

2021-02-18

Start date

2020-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primairy intermediate to high risk prostate cancer

Interventions

None listed

Eligibility

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Patient and lesion-based diagnostic accuracy of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT (sensitivity, specificity, PPV and NPV) in detection of lymph node metastases.	—

Secondary

Measure	Time frame
a. Detection rate of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT for the detection of distant (bone) metastases. b. Diagnostic accuracy of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT in staging of the primary tumor in the radical prostatectomy specimen. c. Diagnostic accuracy of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT for different risk groups (according to the d’Amico classification – see chapter 5.1.3), nomogram risk scores, and the size of malignant lymph nodes. d. Diagnostic performance of 18F-PSMA-1007 PET/CT versus anti-3-[18F] FACBC PET/CT versus conventional imaging (MRI of the prostate) in detection of local tumor site and metastases. e. Change of management induced by 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT findings specifically. f. Cost-effectiveness of 18F-PSMA-1007 PET/CT versus anti-3-[18F] FACBC PET/CT for the detection of (regional) LNMs.	—

Measure

Time frame

a. Detection rate of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT for the detection of distant (bone) metastases. b. Diagnostic accuracy of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT in staging of the primary tumor in the radical prostatectomy specimen. c. Diagnostic accuracy of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT for different risk groups (according to the d’Amico classification – see chapter 5.1.3), nomogram risk scores, and the size of malignant lymph nodes. d. Diagnostic performance of 18F-PSMA-1007 PET/CT versus anti-3-[18F] FACBC PET/CT versus conventional imaging (MRI of the prostate) in detection of local tumor site and metastases. e. Change of management induced by 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT findings specifically. f. Cost-effectiveness of 18F-PSMA-1007 PET/CT versus anti-3-[18F] FACBC PET/CT for the detection of (regional) LNMs.

—

Contacts

Public ContactRobert Hoekstra

Catharina Ziekenhuis Eindhoven

robert.hoekstra@catharinaziekenhuis.nl+31402397040

Outcome results