75 patients with the suspicion on PCa (elevated PSA and/or abnormal digital rectal exam) will receive a PSMA-PET following mpMRI. 25 patients with PIRADS 1-2 (probably benign disease), 25 patients with PIRADS 3 (equivocal disease) and 25 patients with PIRADS 4-5 (highly suspicious for malignancy) will be included in this explorative study. MedDRA version: 20.0 Level: LLT Classification code 10036921 Term: Prostate carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecif
Conditions
Interventions
Product Name: [18F]F-PSMA-1007
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: [18F]F-PSMA-1007
Other descriptive name: [18F]F-PSMA-1007
Concentration unit: MBq/ml megabecque
Sponsors
Radboud University Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Suspicion for PCa (e.g. elevated PSA, suspicious rectal examination) - Males = 18 years - ECOG 0-1 - Signed informed consent 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - Prostate biopsy in the last 6 months - History of prostate cancer - Second active malignancy - Any prior surgery in the pelvic area that might interfere with the scans (e.g. hip replacement surgery) - Any medical condition that in the opinion of the investigator will affect patients’ clinical status when participating in this trial. - Contra-indications for mpMRI or PET: claustrophobia or inability to lay still for the duration of the exam.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This explorative study aims to investigate the added value of a 18F-PSMA-PET to mpMRI in the detection of local prostate cancer lesions.;Secondary Objective: - Analyzing the different findings in terms of number and size on the two imaging modalities mpMRI and 18F-PSMA PET (e.g. multifocal tumors, extracapsular growth, vesicular seminalis infiltration etc.) - Quantitative analyses: SUV measurements, tumor-background ratio’s and correlation of these quantitative parameters derived from 18F-PSMA PET to immuno-histological findings (e.g. PSMA expression level on tumor and non-tumor samples) - Performing a cost-effective analysis for an additional 18F-PSMA PET scan based on final findings (in case 18F-PSMA PET improves the primary staging);Primary end point(s): Within each of the three PIRADS groups (1-2, 3, 4-5) the fraction of patients in which the diagnosis based on mpMRI and 18F-PSMA PET might differ. For patients that have conflicting imaging outcomes, the imaging results are compared with the results of the (target) biopsy.;Timepoint(s) of evaluation of this end point: LVLS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints will be the radiological state of the disease expressed in the difference in number and size of suspicious lesions, the extent of the disease on 18F-PSMA PET and mpMRI, correlation of the standardized uptake value of the PET to the PSMA expression of the immune-histopathology of the biopsy (e.g. ISUP score).(20) Another explorative endpoint is to perform a cost-effectiveness analysis for the additional use of 18F-PSMA PET based on the final findings.;Timepoint(s) of evaluation of this end point: LVLS. | — |
Countries
Netherlands
Contacts
Public ContactProf. J. Nagarajah
Radboud University Medical Center
Outcome results
None listed