Clinical trial NCT03122470: Correlation of Imaging Findings With Clinical Findings and Patient Outcomes in Prostate Cancer
Official title: Assessment of Advanced Imaging Techniques in the Evaluation and Management of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prostate Cancer
Keywords: TRUS biopsy
Pelvic MRI
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: MRI is being increasingly relied upon for detection, staging and management of prostate cancer. In this study patients with risk of prostate cancer will be recommended to have a pelvic MRI prior to the standard biopsy of the prostate and standard treatment of any detected prostate cancer. The results of the MRI will be compared to standard diagnosis techniques to see if cancer can be more accurately detected.

Detailed description: The study team hypothesizes that strategic use of advanced MRI methods will provide a more accurate and less invasive approach for diagnosis and management of prostate cancer. The primary objectives are:

1. To develop advanced MRI methods and optimal MRI protocols for detection, staging, and follow-up of prostate cancer.
2. To evaluate the diagnostic performance of MRI-guided biopsy methods and correlate MRI findings with the pathological grade of cancer.
3. To correlate prostate MRI findings and biopsy results with patient progress and outcomes.
4. To evaluate the diagnostic accuracy of MRI in disease re-classification in patients on active surveillance.

Secondary Objectives:

1. To apply computer-aided advanced image analytic techniques (Computer-assisted diagnostics- CAD) to extract MRI features of patient clinical scans that correlate with diagnosis and grade of prostate cancer.
2. To study MRI features of lesions that mimic prostate cancer on imaging eg - chronic prostatitis, post treatment changes.
3. To evaluate the impact of MRI in decision making and choice of treatment by physicians and patients.

Eligibility criteria: Inclusion Criteria:

* Patients with a suspicion (elevated PSA and/or abnormal digital rectal exam)/ diagnosis of prostate cancer

Inclusion criteria for sub-group follow-up scans:

1a. Patients who have undergone standard TRUS biopsy or TRUS with targeted biopsy (i.e cognitive TRUS, MR-TRUS fusion or TRUS + in-gantry biopsy)

Exclusion Criteria:

* Patients with ferromagnetic or otherwise non-MRI compatible aneurysm clips.
* The presence of an implanted pacemaker or implanted defibrillator device.
* Patients with contraindications for MRI due to embedded foreign metallic objects. Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary risk to the patient.
* Implanted medical device not described above that is not MRI-compatible;
* Known history of severe claustrophobia;
* For patients with known history of allergic reaction to magnetic resonance (MR) contrast material or abnormal kidney function (glomerular filtration rate (GFR) \< 30 mL/min), a contrast enhanced exam will not be performed; however, a non-contrast exam may be performed;
* Minors will be excluded.
* Prisoners and members of other vulnerable populations will be excluded from this study as these populations will not provide any additional unique information to or uniquely benefit from the study.

Primary outcomes:
measure: Number of patients with the most likely diagnosis based on the five-point scale - PIRADS
timeFrame: Up to two weeks after MRI
measure: Number of patients with true diagnosis based on biopsy pathology
timeFrame: Up to two weeks after MRI
Secondary outcomes:
measure: biopsy and MRI based diagnosis match in at least 8/10 patients
timeFrame: Up to two weeks after MRI
measure: Ratio of positive diagnosis as detected by pelvic MRI guided biopsy compared to standard TRUS biopsy
timeFrame: Up to two weeks after MRI
Other outcomes:
Locations:
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
name: Lee Ponsky, MD
role: PRINCIPAL_INVESTIGATOR
References: