Please select the eligibility criteria that correspond to the clinical trial below.
Title: Improvement in the Detection of Aggressive Prostate Cancer by Targeted Biopsies Using Multiparametric MRI Findings
Brief Summary: Background: Prostate cancer is difficult to detect using ultrasound. As a result, in case of suspicion of prostate cancer based on digital rectal examination (DRE) or Prostate Specific Antigen (PSA) level, it is currently recommended to perform "blinded" systematically distributed biopsies with 10-18 samples obtained from predefined locations in the gland.

These so-called systematic biopsies (SB) may lead to improper patient management by (i) missing clinically significant cancer, especially in the anterior half of the gland that tends to be undersampled, (ii) inducing chance detection of clinically insignificant cancer foci that may result in overtreatments, (iii) undersampling the tumor foci and thus underestimating their volume and aggressiveness.

Multiparametric Magnetic Resonance Imaging (mp-MRI) has yielded promising results in detecting aggressive (Gleason ≥7) prostate cancers. Several monocenter studies showed that targeted biopsies (TB) based on mp-MRI findings could detect significantly more aggressive cancers, reduce the diagnosis of clinically insignificant cancers, and better evaluate the aggressiveness of detected cancers than SB. However, these monocenter studies only provide low-level evidence and three recent independent reviews of literature concluded that there was a need for a robust multicenter trial evaluating the diagnostic yield of TB as compared to SB. This is particularly important since many academic and private centers in France already perform mp-MRI before prostate biopsy in daily routine. Therefore the risk is that this approach becomes the norm without being properly evaluated and it is crucial and urgent to perform a controlled multicentric study to provide high-level evidence as to whether mp-MRI should or should not be obtained before prostate biopsy.

One controlled multicentric study has been published recently in which SB and TB had been obtained by two different operators in 95 patients. TB yielded a significantly higher detection rate for all prostate cancers (69% vs 59%, p=0.033) and for clinically significant cancers (67% vs 52%, p=0.0011). However, this study was limited by the fact that patients with negative mp-MRI were not included.

Research hypotheses: There is currently no robust multicenter trial comparing prostate TB based on mp-MRI findings versus the current standard of care (SB). We propose a multicentre prospective trial comparing the results of SB and TB performed in the same patients by two independent operators. Our hypothesis is that TB detects aggressive (Gleason ≥7) cancers in a significantly higher percentage of patients than SB.

Main objective: To compare the percentage of patients with "clinically significant cancer" (using definition A, i.e. cancer with Gleason score ≥7) detected by SB versus TB.


Options:
A: Inclusion Criteria:

* Patient referred for prostate mp-MRI before a first set of prostate biopsies, with a planned time interval of less than 3 months between MRI and biopsies
* Age ≤75 years
* PSA level ≤20 ng/mL
* Clinical stage ≤T2c
* Patient insured under the French social security system or beneficiary of an equivalent regime

Exclusion Criteria:

* Contraindication to transrectal biopsy
* Contraindication to MRI
* History of hip prosthesis
* History of androgen deprivation therapy
* Patients with history of prostate cancer diagnosed on TURP
* Patients with history of pelvic radiation therapy (whatever the reason)
* Patient deprived of freedom following a court or administrative order
* Patient under guardianship or under legal guardianship
B: Inclusion Criteria:

* Informed consent
* Suspected prostate cancer based on PSA value (total PSA 2,5-10 ng/ml and PSA free to total ratio \<=0.15, or total PSA 10-20 ng/ml)
* PSA and serum creatinine measurement less than 60 days before transrectal ultrasound-guided prostate biopsies
* No evidence of PSA increase by non-cancerous factors (catheterization, bladder stones, urinary tract infection including bacterial prostatitis)

Exclusion Criteria:

* Previous prostate biopsies
* Previous prostate surgery
* Contraindication for MRI (such as pacemaker or inner ear implant)
* Claustrophobia
* Estimated glomerular filtration rate (eGFR) \<40 ml/min
* Suspected clinical T3-T4 prostate cancer based on digital rectal examination
* Contraindication for transrectal ultrasound-guided prostate biopsies
* body mass index \>30
C: DISEASE CHARACTERISTICS:

* Men at risk of prostate cancer who have been advised to have a prostate biopsy
* Suspected stage ≤ T2 on rectal examination (organ confined)
* Serum PSA ≤ 15 ng/mL within the past 3 months

PATIENT CHARACTERISTICS:

* Fit for general/spinal anesthesia
* Fit to undergo all protocol procedures including a transrectal ultrasound
* No evidence of a urinary tract infection or history of acute prostatitis within the past 3 months
* No contraindication to MRI (e.g., claustrophobia, pacemaker, or estimated GFR ≤ 50)
* No other medical condition precluding procedures described in the protocol

PRIOR CONCURRENT THERAPY:

* No prior prostate biopsy, prostate surgery, or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction are acceptable)
* No prior hip replacement surgery
D: Inclusion Criteria:

* Age: 40 to 85 years
* Clinical suspicion of prostate cancer based on: serum level of PSA from 2,5 ng/ml to 25 ng/ml in two following measurements and/or abnormal digital rectal examination
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* previous prostate biopsy in the last 6 months
* previous diagnosis of prostate carcinoma
* previous prostate surgeries, e.g. TURP (transurethral prostatic resection)
* symptomatic of acute prostatitis
* contraindications for MRI (cardiac pacemaker, intracranial clips etc)
* uncontrolled serious infection
* claustrophobia
* any other conditions that might compromise patients safety, based on the clinical judgment of the responsible urologist

Answer: A