Abbreviated Name

P-MRI

Lead Investigator

Salami, Simpa S — University of Michigan Recruiting

Coordinating Investigator

Zheng, Yingye — Fred Hutchinson Cancer Center

Involved Investigators

• Watts, Kara — Montefiore Medical Center
• Liss, Michael — The University of Texas Health Science Center, San Antonio
• Olumi, Aria — Beth Israel Deaconess Medical Center
• Crichton, Dan — NASA Jet Propulsion Laboratory
• Gaston, Sandra M. — University of Miami Miller School of Medicine
• Kibel, Adam — Brigham and Womens Hospital
• Sonn, Geoffrey — Stanford University Medical Center
• Salami, Simpa — University of Michigan Pathology
• Pow-Sang, Julio — H. Lee Moffitt Cancer Center and Research Institute, inc.
• Fang, Andrew M — University of Alabama at Birmingham
• McClure, Tim — Cornell University
• Chan, Daniel — Johns Hopkins Medical Institutions
• Sanda, Martin — Emory University School of Medicine
• Barocas, Dan — Vanderbilt University
• Lotan, Yair — UT Southwestern Medical Center at Dallas
• Hutchinson, Amy — Frederick National Laboratory for Cancer Research
• Srivastava, Sudhir — National Cancer Institute
• Punnen, Sanoj — University of Miami
• Pavlovich, Christian — Johns Hopkins University
• Nyame, Yaw — University of Washington
• Liss, Michael — University of California, San Diego
• Zheng, Yingye — Fred Hutchinson Cancer Center
• Salami, Simpa S — University of Michigan Recruiting

Abstract

No abstract availalbe.

Aims

Specific aim 1. To examine the incremental specificity for high grade prostate cancer (i.e. > Gleason sum 6) of prostate MRI above and beyond PSA, PCA3 and TMPRSS2:ERG with the sensitivity held constant at 90% in the initial biopsy setting. Specific aim 2. To evaluate the potential for novel laboratory biomarkers, including but not limited to urine RNA sequencing chip, tissue prints for biomarker field effect to predict findings on MRI 2a. To evaluate the relationships between laboratory biomarkers and MRI sequences. 2b. To develop an algorithm that optimizes laboratory biomarkers to predict high-grade prostate cancer from a prostate MRI fusion biopsy. Specific aim 3. To evaluate the role of radiomics to improve upon standard MRI protocols in the diagnosis of high-grade prostate cancer Specific aim 4. (Longitudinal) To evaluate how changes in laboratory biomarkers and prostate MRI over a two-year period predicts subsequent diagnosis of high-grade prostate cancer Specific aim 5. To expand the current EDRN’s unique pre-diagnostic reference set with RNA sequencing of pre-biopsy urine. We will apply the uMIPS RNA sequencing chip on banked urine samples from the PCA3 cohort. This will be evaluated on those who underwent initial and repeat prostate biopsies.    5a: To conduct a head-to-head comparison of urine biomarkers for the detection of HG Pca on needle biopsy. This may include commercial assays such as SelectMDx if they provide support to run their assays.    5b: To develop a novel algorithm based on 83 distinct RNA sequences on uMIPS_v1 for the detection of HG Pca. Specific aim 6. To evaluate the potential for precancerous lesions to progress to invasive over a two-year period. We will follow cases of isolated high-grade PIN and isolated PINatyp with a targeted biopsy at two years using the targeted biopsy software. Our primary endpoint will examine concordance of erg status between PIN and cancer when found in the same location upon repeat biopsy. A secondary endpoint will be finding of any cancer at the same location as prior PIN even if erg status differs. Only cases with PIN and without invasive cancer at initial biopsy will be included. If successful, we would have tested the value of MRI above and beyond PCA3 and TMPRSS2:erg fusion. If the null hypothesis is rejected, we would conclude that MRI in the setting of an initial prostate biopsy is value added and should be included in the evaluation of men in the initial biopsy setting when PCA3 and TMPRSS2:erg fusion are performed.

Analytic Method

see Protocol

Comments

No comments available.

Outcome

Ongoing

Secure Outcome

No secure outcome available.

Publications

• No publications available at this time for this protocol.

Biomarkers

• No biomarkers available at this time for this protocol.

Data Collections

• No data collections available at this time for this protocol.

Start Date

Oct 12 2017

Estimated Finish Date

Aug 31 2027

Protocol ID

430

Protocol Type

Validation

Fields of Research

• Other
• Proteomics

Collaborative Group

Prostate and Urologic Cancers Research Group

Cancer Types

• Malignant neoplasm of prostate

Phased Status

2