Establish if There Are Differences Between Transrectal and Transperineal Prostatic Biopsy Schemes in Both Cases With and Without MRI Clinical Trial
— RMPBX201801Official 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.
| Status | Not yet recruiting |
| Enrollment | 628 |
| Est. completion date | December 31, 2021 |
| Est. primary completion date | June 30, 2020 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 45 Years to 75 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Francisco Gómez Veiga | Salamanca |
| Lead Sponsor | Collaborator |
|---|---|
| InvestigatorUrologyIBSAL | Instituto de Investigación Biomédica de Salamanca |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Comparation between transrectal and transperineal prostatic biopsy with o without Magnetic Resonance | Establish if there are differences between the transrectal and transperineal prostatic biopsy schemes in both cases with and without MRI, in patients with suspected clinical risk of prostate cancer (total PSA between 3 and 20 ng / mL, free PSA index / Total PSA less than 20% and normal or abnormal rectal examination) in terms of efficacy measured by the detection rate and tumor aggressiveness of the tumors detected, complication rates and cost analysis. | 6 months |