cancer of the prostate prostate cancer
Conditions
Interventions
PSMA-PET/CT and FACBC-PET/CT, prior to lymph node dissection (PLND)
Sponsors
Catharina-ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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: A potential subject who meets any of the following criteria will be excluded from participation in this study: 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 |
|---|---|
| Main study parameter is patient- and lesion-based diagnostic accuracy of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT in detection of lymph node metastases. Secondary study parameters are (a) diagnostic performance of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT in detection of distant metastases, (b) diagnostic performance of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT in staging of the primary tumor in the prostate specimen, (c) detection rate of 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT as a function of PSA level, nomogram risk and size of suspected lymph nodes, (d) change of management induced by 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT and (e) cost-associated with 18F-PSMA-1007 PET/CT and anti-3-[18F] FACBC PET/CT as diagnostic modality additional to the regular diagnostic work-up versus pelvic lymph node dissection. | — |
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. | — |
Countries
Netherlands
Outcome results
None listed