Prostatic CancerNCT03354416
Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer
An observational study of Prostatic Cancer and Prostatic Neoplams, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Cancer, Prostatic Neoplams, Prostatic Hyperplasia
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2018to 31 Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: primary clinical
Who may be able to join
- 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.
Who cannot join
- -none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
About this study
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.
Read more
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.
- 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
- Medical subject headings
- Prostatic Neoplasms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/ Cohort 1 | Subjects with an increased risk of prostate cancer or a diagnosis of prostatic cancer or suspicious for prostatic cancer lesions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Associations between imaging features and clinicopathological factors
Radiological profiling of patients with prostate cancer
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start26 Feb 2018
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prostatic CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ismail B Turkbey, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354416
- Sponsor's protocol ID
- 180017
- Other IDs
- 18-C-0017
- Status last verified
- 13 Oct 2026
- First submitted
- 25 Nov 2017
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD recorded in the medical record will be shared with intramural investigators upon request.
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 27088600Wang 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 25525604Lavery 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 27998677Esengur 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 39996409Lin 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 38713024Yilmaz 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer
- ClinicalTrials.gov ID
- NCT03354416
- Acronym / sponsor ID
- 180017
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/ Cohort 1 | – | –Subjects with an increased risk of prostate cancer or a diagnosis of prostatic cancer or suspicious for prostatic cancer lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary clinical
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- -none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Associations between imaging features and clinicopathological factors
Time frame: 10 years
Radiological profiling of patients with prostate cancer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 27088600Toth 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.
- Background: PubMed 25525604Wang 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.
- Background: PubMed 27998677Lavery 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.
- Derived from this study: PubMed 39996409Esengur 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.
- Derived from this study: PubMed 38713024Lin 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.
- Derived from this study: PubMed 37129493Yilmaz 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD recorded in the medical record will be shared with intramural investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ismail B Turkbey, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Cancer and Prostatic Neoplams, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yolanda L McKinney, R.N. ((240) 760-6095, ymckinney@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Associations between imaging features and clinicopathological factors (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03354416, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.