Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer

NCT03354416 | Recruiting

• 2 other identifiers: 18001718-C-0017
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Prostate cancer is one of the most common cancers for men in the U.S. There are some new ways to take pictures of the cancer. There are also new ways to use image-guided biopsy and therapy. These could help manage prostate cancer. Researchers want to study how imaging can provide a profile of prostate cancer. They want to collect data to make diagnosis and treatments better. Objectives: To gather data about the radiological and clinical course of prostate cancer. To study imaging-based biomarkers of prostate cancer. Eligibility: Men ages 18 and older with diagnosed or suspected prostate cancer Design: Participants will give permission for researchers to use their medical history and records. Their data will be reviewed, collected, and analyzed. These include results of their tests and scans. Sponsoring Institution: National Cancer Institute

Conditions

Prostatic Cancer; Prostatic Neoplams; Prostatic Hyperplasia; Prostate Cancer; Cancer Of Prostate

Keywords

Imaging-Based Prognostic Markers; Multiparametric MRI (mpMRI); Translation of Imaging into Treatment Decisions; Decision-Support System; Artificial Intelligence Research; Natural History

Outcome Measures

Primary Outcomes (1)

• Associations between imaging features and clinicopathological factors

  Radiological profiling of patients with prostate cancer

  10 years

Study Arms (1)

1/ Cohort 1

Subjects with an increased risk of prostate cancer or a diagnosis of prostatic cancer or suspicious for prostatic cancer lesions.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary clinical

You may qualify if:

• Patients with an increased risk for prostate cancer (strong family history and/or germline mutation in DNA repair genes), or with a diagnosis of prostatic cancer or suspicious for prostatic cancer lesions.
• Age greater than or equal to 18 years
• Ability of subject to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• none

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (6)

• Toth R, Sperling D, Madabhushi A. Quantifying Post- Laser Ablation Prostate Therapy Changes on MRI via a Domain-Specific Biomechanical Model: Preliminary Findings. PLoS One. 2016 Apr 18;11(4):e0150016. doi: 10.1371/journal.pone.0150016. eCollection 2016.

  PMID: 27088600 BACKGROUND

• Wang S, Burtt K, Turkbey B, Choyke P, Summers RM. Computer aided-diagnosis of prostate cancer on multiparametric MRI: a technical review of current research. Biomed Res Int. 2014;2014:789561. doi: 10.1155/2014/789561. Epub 2014 Dec 1.

  PMID: 25525604 BACKGROUND

• Lavery HJ, Cooperberg MR. Clinically localized prostate cancer in 2017: A review of comparative effectiveness. Urol Oncol. 2017 Feb;35(2):40-41. doi: 10.1016/j.urolonc.2016.11.013. Epub 2016 Dec 18.

  PMID: 27998677 BACKGROUND

• Esengur OT, Stevenson E, Stecko H, Lay NS, Yang D, Tetreault J, Xu Z, Xu D, Yilmaz EC, Gelikman DG, Harmon SA, Merino MJ, Gurram S, Wood BJ, Choyke PL, Pinto PA, Turkbey B. Assessing the Impact of Transition and Peripheral Zone PSA Densities Over Whole-Gland PSA Density for Prostate Cancer Detection on Multiparametric MRI. Prostate. 2025 May;85(6):612-624. doi: 10.1002/pros.24863. Epub 2025 Feb 25.

  PMID: 39996409 DERIVED

• Lin Y, Yilmaz EC, Belue MJ, Harmon SA, Tetreault J, Phelps TE, Merriman KM, Hazen L, Garcia C, Yang D, Xu Z, Lay NS, Toubaji A, Merino MJ, Xu D, Law YM, Gurram S, Wood BJ, Choyke PL, Pinto PA, Turkbey B. Evaluation of a Cascaded Deep Learning-based Algorithm for Prostate Lesion Detection at Biparametric MRI. Radiology. 2024 May;311(2):e230750. doi: 10.1148/radiol.230750.

  PMID: 38713024 DERIVED

• Yilmaz EC, Shih JH, Belue MJ, Harmon SA, Phelps TE, Garcia C, Hazen LA, Toubaji A, Merino MJ, Gurram S, Choyke PL, Wood BJ, Pinto PA, Turkbey B. Prospective Evaluation of PI-RADS Version 2.1 for Prostate Cancer Detection and Investigation of Multiparametric MRI-derived Markers. Radiology. 2023 May;307(4):e221309. doi: 10.1148/radiol.221309. Epub 2023 May 2.

  PMID: 37129493 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ismail B Turkbey, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yolanda L McKinney, R.N.

CONTACT

(240) 760-6095; ymckinney@mail.nih.gov

Ismail B Turkbey, M.D.

CONTACT

(240) 760-6112; turkbeyi@mail.nih.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2017
• First Posted: November 28, 2017
• Study Start: February 26, 2018
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2033
• Last Updated: April 29, 2026

Record last verified: 2026-04-23

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Clinical data available during the study and indefinitely.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (1)