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

NCT ID: NCT04283032

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 628 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-12-31

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 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Multiparametric magnetic resonance + transrectal biopsy

The patient underwent a previous multiparametric magnetic resonance (RMmp) and a transrectal biopsy (BPTE)

Multiparametric magnetic resonance

Intervention Type: PROCEDURE

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).

Multiparametric magnetic resonance + transperineal biopsy

The patient underwent a previous multiparametric magnetic resonance (RMmp) and a transperineal biopsy (BPTP)

Multiparametric magnetic resonance

Intervention Type: PROCEDURE

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).

Transrectal biopsy

The patient underwent a transrectal biopsy (BPTE)

No interventions assigned to this group

Transperineal biopsy

The patient underwent a transperineal biopsy (BPTP)

No interventions assigned to this group

Interventions

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).

Intervention Type: PROCEDURE

Other Intervention Names

Transrectal biopsy; Transperineal biopsy

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Biomédica de Salamanca

OTHER

Sponsor Role: collaborator

InvestigatorUrologyIBSAL

OTHER

Sponsor Role: lead

Responsible Party

InvestigatorUrologyIBSAL

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Francisco Gómez Veiga

Salamanca, , Spain

Countries

Spain

Central Contacts

Francisco Gomez Veiga

Role: CONTACT

fgveiga@telefonica.net

923291100 ext. 55954

Facility Contacts

Francisco Gomez Veiga, Dr.

Role: primary

fgveiga@telefonica.net

Other Identifiers

PI18/01560

Identifier Type: -

Identifier Source: org_study_id