Clinical suspected prostate cancer MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 68Ga-PSMA HBED-CC
Pharmaceutical Form: Injection
INN or Proposed INN: not yest assigned (according to MPCR)
Current Sponsor code: 68GA-PSM
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Clinical suspicion of prostate cancer: • blood PSA level > 4.0 ng/ml and/or • free-to-total PSA ratio =65 years) yes F.1.3.1 Number of subjects for this age range 165
Exclusion criteria
Exclusion criteria: • antiandrogen therapy • prostate needle biopsy <21 days before PET/MRI • known active secondary cancer • endorectal coil not applicable (e.g. anus praetor with short rectal stump) • known active prostatitis (e.g. painful DRE) • known anaphylaxis against gadolinium-DTPA • patient’s written informed consent not given
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint is the tumor status after standard and/or image guided biopsy (when positive) or combined standard and image guided biopsy (when negative). ;Timepoint(s) of evaluation of this end point: Tumor status will be evaluated after needle biopsy.;Main Objective: We hypothesize that the image guided biopsy using multiparametric metabolic hybrid imaging with [18F]Fluoroethylcholine (FEC)/[68]Ga-PSMA-PET/MRI is superior in the detection of primary localized prostate cancer than the conventional biopsy approach with transrectal ultrasound in patients with suspected prostate cancer (according to the inclusion criteria) and could therefore significantly improve the detection rate of the dominant intraprostatic tumor lesion and reduce the number of biopsies needed for a correct histopathological diagnosis to a minimum in the future (PET/MRI guided biopsy).; Secondary Objective: • This method should enable improved tumor characterization. A diagnostic accuracy of >80% is assumed in lesions >5mm (in axial, sagittal and coronal extension) for the ability of the multiparametric metabolic method to differentiate between Gleason =3+4=7 (7a) tumors and =4+3=7 (7b) tumors (as compared to histological whole mount tumor mapping) and to identify patients with a high risk of developing metastatic disease (as compared to the loss of the transcription factor STAT3(signal transducer and activator of transcription 3) and cell cycle regulator p14 in a molecular pathological workout of the radical prostatectomy specimen). • To evaluate, if the applied parameters of multiparametric metabolic imaging with FEC- and PSMA-PET/MRI are associated with the evidence of an early biochemical relapse after a PSA nadir <0.2ng/ml after primary treatment in a two years follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Prognosis quality of the aggressiveness of carcinoma compared between the standard and the image guided study arm measured via dichotomized Gleason score.;Timepoint(s) of evaluation of this end point: Evaluation of the secondary endpoint will be done after end of study visit (Visit 1, when no surgery is planned for the patient; End of Study visit for patients who undergo surgery) | — |
Countries
Austria
Contacts
Public ContactDr. Markus Hartenbach
Medical University of Vienna
Outcome results
None listed