ClinicalTrials.gg
RecruitingNCT03354416Updated Oct 16, 2026

Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer

An observational study in Prostatic Cancer, Prostatic Neoplams and Prostatic Hyperplasia, sponsored by National Cancer Institute (NCI). Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by National Cancer Institute (NCI) · Observational

From the registry’s dates

  • Started Feb 2018; still recruiting 8 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
10,000
Ages
18 Years and older
Sex
Male
01

Study 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

Read the detailed description

Background:

  • Multiparametric MRI (mpMRI) has become an established method for localizing clinically significant prostate cancer, and identification of imaging-based prognostic markers represents an active research area.
  • Multiple treatments are available for patients with localized prostate cancer, including radical prostatectomy, external beam radiotherapy, brachytherapy, and focal ablation; however, therapy-specific indication and imaging-based response biomarkers are poorly understood.
  • As mpMRI is considered a standard of care , there is no patient consent for research related to imaging biomarkers and their correlation with other clinical and pathologic features.
  • Translation of imaging, clinical, and pathological-based features into treatment decisions has yet to be fully characterized for development of a decision-support system.
  • Therefore, the purpose of this protocol is to enable the collection of data to enable research in the development of computer aided diagnosis, decision support and deep learning/artificial intelligence research.

Objective:

-To evaluate radiological profiling of patients with prostate cancer in support of the Molecular Imaging Branch (MIB) for identification of imaging-based prognostic markers in prostate cancer.

Eligibility:

  • Patients with an increased risk for prostate cancer, with a diagnosis of prostatic cancer or suspicious for prostatic cancer lesions.
  • Age > 18 years.

Design:

-Imaging evaluation and clinical profiling of patients with an increased risk of prostate cancer, with prostate cancer or suspected of prostate cancer (obtained during visits to NIH or from external providers) will be collected over the course of at least 5 years and analyzed.

02

Conditions studied

  • 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
03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 200 across 1,310 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

primary clinical

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 document.

Exclusion criteria

EXCLUSION CRITERIA:

-none

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
10,000 participants (estimated)

Groups and cohorts

  • 1/ Cohort 1

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

06

What researchers measure

Primary outcomes

  1. Associations between imaging features and clinicopathological factors

    Radiological profiling of patients with prostate cancer

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact National Cancer Institute Referral Office · Contact888-624-1937
08

References and documents

Publications

  • 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. PubMed 27088600 ↗
  • 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. PubMed 25525604 ↗
  • 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. PubMed 27998677 ↗
  • 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. PubMed 39996409 ↗
  • 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. PubMed 38713024 ↗
  • 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. PubMed 37129493 ↗

Individual participant data

Plan to share: Yes — All IPD recorded in the medical record will be shared with intramural investigators upon request.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

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.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2018 (actual). Primary completion is estimated for Dec 2030, 154 months after the start.

Of 541 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 162. This study's planned 154 months is above that.

Counting every sponsor, half of 650 studies reached it within 60 months; a quarter within 29 and three quarters within 141.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 25, 2017
First posted
Nov 28, 2017
StartActual
Feb 26, 2018
Primary completionEst.
Dec 31, 2030
CompletionEst.
Dec 31, 2033
Last update
Oct 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03354416
Responsible party
Sponsor
First posted
Nov 28, 2017
Start date
Feb 26, 2018
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2033 (estimated)
Last update
Oct 16, 2026

Study contacts

Yolanda L McKinney, R.N.
Contact
ymckinney@mail.nih.gov
(240) 760-6095
Ismail B Turkbey, M.D.
Contact
turkbeyi@mail.nih.gov
(240) 760-6112
Ismail B Turkbey, M.D.
principal investigator · National Cancer Institute (NCI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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