Skip to content

Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer

Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03354416
Enrollment
10000
Registered
2017-11-28
Start date
2018-02-26
Completion date
2033-12-31
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Of Prostate, Prostate Cancer, Prostatic Cancer, Prostatic Hyperplasia, Prostatic Neoplams

Keywords

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

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

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.

Interventions

None listed

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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 informed consent document.

Exclusion criteria

-none

Design outcomes

Primary

MeasureTime frameDescription
Associations between imaging features and clinicopathological factors10 yearsRadiological profiling of patients with prostate cancer

Countries

United States

Contacts

CONTACTYolanda L McKinney, R.N.
ymckinney@mail.nih.gov(240) 760-6095
CONTACTIsmail B Turkbey, M.D.
turkbeyi@mail.nih.gov(240) 760-6112
PRINCIPAL_INVESTIGATORIsmail B Turkbey, M.D.

National Cancer Institute (NCI)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026