prostata cancer C61
Conditions
Interventions
Group 1: No tumor detection in mpMRT (PI-RADS 1-2):
No biopsy will be performed, only further medical data will be captured (DRE, TRUS, PSA). If an indication for a biopsy should develop (e.g. high P
Sponsors
ATURO
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: - Male patients between 18 and 75 years - Suspect PSA history or suspect digital rectal examination (DRE) - Tumor category: cT1c (neither palpable nor visible in imaging techniques) or cT2 (limited to prostate) - No suspicion for extraprostatic extension of tumor or metastases according to DRE, TRUS, and clinical examination. - No previous prostate biopsy - No general contraindications for MRI: (e.g. cardiac pacemakers, cochlear implants, implanted insulin or pain pumps, metallic vessel clips, neurostimulators, magnetic dental implants) - No participation in other interventional trials.
Exclusion criteria
Exclusion criteria: Only criteria for inclusion in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) The number of prostate biopsies which are avoided by use of an mpMRI (multiparametric MRI) will be determined. 2) The detection rate of clinically insignificant carcinoma (Gleason 6) with positive mpMRI findings will be determined. 3) The rate of missed clinically significant carcinoma with negative mpMRI findings will be determined. Follow-up three years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Estimation of the detection rate of clinically significant PCa of cognitive fusion biopsy and software-based MRI/TRUS fusion biopsy. 2. Estimation of number and rate of complications of cognitive fusion biopsy and software-based MRI/TRUS fusion biopsy. 3. Correlation of results of different biopsy techniques and prostatectomy with results of mpMRI. 4. Estimation of number and rate of mpMRI examinations that theoretically could be avoided using the score of the Rotterdam risk calculator for stratification. 5. Evaluation of psychological distress experienced by patients before mpMRI and after diagnosis of PCa. | — |
Countries
Germany
Contacts
Public ContactElke Hempel
SMG Forschungsgesellschaft mbH
Outcome results
None listed