Please select the eligibility criteria that correspond to the clinical trial below.
Title: PROMIS - Prostate MRI Imaging Study - Evaluation of Multi-Parametric Magnetic Resonance Imaging in the Diagnosis and Characterization of Prostate Cancer
Brief Summary: RATIONALE: Diagnostic procedures, such as magnetic resonance imaging (MRI), may help find prostate cancer and learn the extent of disease.

PURPOSE: This clinical trial is studying the safety of MRI and to see how well it works in diagnosing prostate cancer.


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:

* 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
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:

Patients must fulfill all of the following criteria to be eligible for study admission. Patient enrollment is by referral only.

1. All patients must have a pre-operative imaging (CT, MR, or PET scan) available in digital format.
2. Age greater than or equal to 18 years.
3. No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
4. The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol. If in question, an ethics consult will be obtained.
5. All patients in non-prostate biopsy cohorts, must be undergoing an image-guided surgical or interventional radiology procedure such as an angiography or a CT/ US-guided biopsy as clinically indicated or IRB-approved under a separate research protocol.

PROSTATE BIOPSY COHORT (Cohorts 1 and 9) INCLUSION CRITERIA:

1. Patients are eligible if they have undergone a prostate MRI and have had abnormalities identified as follows:

1. PSA \>2.5 OR abnormal digital rectal exam OR an abnormality identified on prostate MRI with a clinical indication for fusion biopsy
2. Pre-biopsy prostate MRI showing targetable lesions

EXCLUSION CRITERIA:

Patients with any of the following will be excluded from study entry:

1. Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study.
2. Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure.
3. Inability to hold breath, if procedure will be performed with conscious sedation, and without general anesthesia.
4. Patients with pacemakers and other potentially electrically conductive implants.
5. Gross body weight above the CT table limit (606 pounds), if CT table used.

Answer: A