Clinical trial · Observational
Impact of Magnetic Resonance and Biomarkers for Screening for Prostate Cancer. Cost-effectiveness Analysis
Impact of Magnetic Resonance and Biomarkers for Screening for Prostate Cancer With Different Approaches. Cost-effectiveness Analysis (RMP-BX 2018-01)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Establish if There Are Differences Between Transrectal and Transperineal Prostatic Biopsy Schemes in Both Cases With and Without MRI | — | UNRESOLVED | — |
| Establish the Association of the Tumor Biomarker in the Early Detection and Aggressiveness of Tumors | — | UNRESOLVED | — |
| Establish the Efficacy Between the Four Schemes in Terms of Morbidity Associated With the Technique | — | UNRESOLVED | — |
| Establish the Efficacy Between the Four Schemes in Terms of the Aggressiveness of the Tumors According to the Gleason Classification | — | UNRESOLVED | — |
| Establish the Efficacy Between the Four Schemes in Terms of the Patient's Subjective Perception Regarding Pain and Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiparametric magnetic resonance | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Multiparametric magnetic resonance + transrectal biopsy
- description
- The patient underwent a previous multiparametric magnetic resonance (RMmp) and a transrectal biopsy (BPTE)
- interventionNames
- Procedure: Multiparametric magnetic resonance
- label
- Multiparametric magnetic resonance + transperineal biopsy
- description
- The patient underwent a previous multiparametric magnetic resonance (RMmp) and a transperineal biopsy (BPTP)
- interventionNames
- Procedure: Multiparametric magnetic resonance
- label
- Transrectal biopsy
- description
- The patient underwent a transrectal biopsy (BPTE)
- label
- Transperineal biopsy
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
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