Please select the eligibility criteria that correspond to the clinical trial below.
Title: PICTURE - Prostate Imaging (Multi-parametric MRI and Prostate HistoScanning™) Compared to Transperineal Ultrasound Guided Biopsy for Significant Prostate Cancer Risk Evaluation.
Brief Summary: The incidence of prostate cancer is rising however the number of deaths from prostate cancer is stable. Meaning the investigators are diagnosing many men with prostate cancer that will not impact on their life. The rise in incidence is mainly due to increased use of the blood test Prostate Specific Antigen (PSA), as a screening test.

Currently men suspected of having prostate cancer, identified by a raised PSA undergo trans-rectal ultrasound guided prostate biopsy (TRUS biopsy). Many men have this test unnecessarily, only 1/3 being diagnosed with prostate cancer. TRUS biopsy is problematic as it is random and performed blind-the operator does not know where the cancer is. Thus many low-risk cancers that do not need treating are diagnosed and many high risk cancers are missed or incorrectly classified. So, men with a negative biopsy or those with low risk disease are usually advised to undergo another TRUS biopsy.

An imaging test is needed that could help men and their doctors decide whether the biopsy is a true reflection of what is inside his prostate.

The investigators will test the role of two imaging tests. The first, multi-parametric magnetic resonance imaging (mp-MRI) uses magnetic signals from the body to form images. The second, Prostate HistoScanning™ (PHS) uses sound-waves. The investigators will compare the results of these tests with a detailed biopsy map-transperineal template prostate mapping biopsy (which is currently the best way to find out what is in the prostate but requires multiple biopsies to be taken under general anaesthetic. Eligible men will have undergone one or more TRUS biopsies and who have been advised to have further tests on as part of standard of care. They will be recruited from UCLH referral letters and clinics.

The investigators aim is to see if either of these tests can confidently rule out the presence of clinically important disease.


Options:
A: 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
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: 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
D: Inclusion Criteria:

* Men who have undergone prior trans-rectal biopsies.
* Men undergoing further evaluation of their prostate and who are seeking characterisation using Transperineal Template Prostate Mapping Biopsy.

Exclusion Criteria:

* Previous history of prostate cancer treatment
* Men unable to have MRI scan, or in whom artefact would reduce quality of MRI.
* Men unable to have general or regional anaesthesia
* Men unable to give informed consent

Answer: D