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Impact of Magnetic Resonance and Biomarkers for Screening for Prostate Cancer. Cost-effectiveness Analysis

NCT04283032 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 628

Last updated 2020-02-25

No results posted yet for this study

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 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.

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
  • Establish the Efficacy Between the Four Schemes in Terms of the Patient's Subjective Perception Regarding Pain and Quality of Life
  • Establish the Association of the Tumor Biomarker in the Early Detection and Aggressiveness of Tumors
  • Establish the Possible Interaction Between Biomarkers and Resonance in Different Prostate Biopsy Models to Define Tumor Presence and / or Tumor Aggressiveness
  • Establish the Possible Relationship Between the Expression Profiles of the microRNAs
  • Establish if There Are Differences Between Transrectal and Transperineal Prostatic Biopsy Schemes in Both Cases With and Without MRI

Interventions

PROCEDURE

Multiparametric magnetic resonance

MRI uses a powerful magnetic field, pulsed radiofrequency and a computer to create detailed images of organs, soft tissues, bones, and practically the rest of the internal structures of the body. MRI does not use ionizing radiation (X-rays).

Sponsors & Collaborators

  • Instituto de Investigación Biomédica de Salamanca

    collaborator OTHER

  • InvestigatorUrologyIBSAL

    lead OTHER

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2020-06-30
Completion
2021-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04283032 on ClinicalTrials.gov