Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer

Recruiting

• Conditions: Prostatic Hyperplasia; Cancer Of Prostate; Prostatic Cancer; Prostate Cancer; Prostatic Neoplams

• Registration Number: NCT03354416
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study First Submitted: 2017-11-25
• Study First Submitted QC: 2017-11-25
• Study First Posted: 2017-11-28
• Study Start: 2018-02-26
• Status Verified: 2025-05-19
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Primary Completion: 2030-12-31
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 10000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Associations between imaging features and clinicopathological factors	10 years	Radiological profiling of patients with prostate cancer

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States