Recruiting

Observational Study

Sponsor:

National Cancer Institute (NCI)

Code:

NCT03354416

Conditions

Prostatic Cancer

Prostatic Neoplams

Prostatic Hyperplasia

Prostate Cancer

Cancer Of Prostate

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT03354416

Start date

Feb 26, 2018

Status verified date

Aug 25, 2026

Completion date

Dec 31, 2033

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

1/ Cohort 1

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

Primary outcome measure

  • Associations between imaging features and clinicopathological factors [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Yolanda L McKinney, R.N.

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

Ismail B Turkbey, M.D.

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

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 8, 2026

Last verified

Aug 25, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-08.