Establish if There Are Differences Between Transrectal and Transperineal Prostatic Biopsy Schemes in Both Cases With and Without MRI Clinical Trial
Official title:
Impact of Magnetic Resonance and Biomarkers for Screening for Prostate Cancer With Different Approaches. Cost-effectiveness Analysis (RMP-BX 2018-01)
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 Magnetic Resonance (RMmp) in patients with clinical suspicion of prostate
cancer (PC) to first prostatic biopsy in terms of:
1. Rate of detection and diagnosis of prostate cancer.
2. Aggressiveness of the detected tumors.
3. Association of the marker [-2] proPSA and the prostate cancer health index (PHI) and
microRNAs for the diagnosis of tumors.
4. Adverse effects of the intervention and subjective perception of the patient: pain and
degree of satisfaction, and impairment of quality of life.
5. Cost-effectiveness analysis of the different intervention options.
Study Design: Randomized, single-blind prospective clinical study to compare four schemes:
RMmp + BPTE vs. BPTE 12 cylinders vs RMmp + BPTP vs BPTP 12 cylinders.
Study population: Patients with clinical suspicion of prostate cancer with PSA between 3-20
ng / mL and normal or abnormal rectal examination, candidates for a first prostate biopsy.
Research techniques: BPTE standard of 12 cylinders compared to RMmp previous to BPTE vs BPTP
of 12 cylinders compared to BPTP with previous RMmp.
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