Clinical trial NCT04283032: Impact of Magnetic Resonance and Biomarkers for Screening for Prostate Cancer. Cost-effectiveness Analysis
Official title: Impact of Magnetic Resonance and Biomarkers for Screening for Prostate Cancer With Different Approaches. Cost-effectiveness Analysis (RMP-BX 2018-01)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Keywords: Prostate Cancer
Biomarkers
PSA
MMPm
Quality of Life
Lead sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Biomédica de Salamanca
First posted: 2020-02-25
Enrollment: 628
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspected clinical risk of prostate cancer with total PSA values between 3 and 20 ng / mL, free PSA index / total PSA less than 20% and normal or abnormal rectal examination, candidates for a first prostate biopsy

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.


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.

Primary outcomes:
measure: Comparation between transrectal and transperineal prostatic biopsy with o without Magnetic Resonance
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Francisco Gómez Veiga
Study officials:
References: