Status:
UNKNOWN
Impact of Magnetic Resonance and Biomarkers for Screening for Prostate Cancer. Cost-effectiveness Analysis
Lead Sponsor:
InvestigatorUrologyIBSAL
Collaborating Sponsors:
Instituto de Investigación Biomédica de Salamanca
Conditions:
Establish the Efficacy Between the Four Schemes in Terms of the Aggressiveness of the Tumors According to the Gleason Classification
Establish the Efficacy Between the Four Schemes in Terms of Morbidity Associated With the Technique
Eligibility:
MALE
45-75 years
Brief Summary
Objectives: To establish if there are differences between an ultrasound-guided transrectal prostate biopsy (BPTE) and a transperineal prostatic biopsy (BPTP) with and without a multiparametric Magneti...
Eligibility Criteria
Inclusion
- Signature of informed consent prior to performing any of the specific procedures of the study
- Age between 50 \* - 75 years (\* 45 years, if family history)
- Patients with clinical suspicion of prostate cancer
- Indication of a first biopsy during the study period.
- Life expectancy greater than 10 years.
Exclusion
- Patients previously randomized in the present study.
- Patients submitted prior to a prostate biopsy.
- Patients with a previous diagnosis of prostate cancer and / or previous prostate surgery.
- Patients with a previous episode of acute prostatitis of infectious origin in the 3 months prior to inclusion in the study.
- Patients with an active urinary tract infection and / or any previous pathology of severity in the 3 months prior to inclusion.
- Impossibility of performing transrectal or transperineal biopsy and / or magnetic resonance.
- Patients who have received hormonal treatment prior to androgen blockade in the 6 months prior to inclusion in the study.
- History of other tumors.
Key Trial Info
Start Date :
March 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
628 Patients enrolled
Trial Details
Trial ID
NCT04283032
Start Date
March 1 2020
End Date
December 31 2021
Last Update
February 25 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Francisco Gómez Veiga
Salamanca, Spain, 37007