Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT03354416
Collaborator
(none)
10,000
1
154.1
64.9

Study Details

Study Description

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 greater than or equal to 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 NCI and long-term follow up will be collected and analyzed.

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer
Actual Study Start Date :
Feb 26, 2018
Anticipated Primary Completion Date :
Dec 31, 2027
Anticipated Study Completion Date :
Dec 31, 2030

Arms and Interventions

Arm Intervention/Treatment
1/ Cohort 1

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

Outcome Measures

Primary Outcome Measures

  1. Associations between imaging features and clinicopathological factors [10 years]

    Radiological profiling of patients with prostate cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
  • 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.

  • Subject must be enrolled on an NIH screening, diagnostic or treatment protocol

EXCLUSION CRITERIA:

-none

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Institutes of Health Clinical Center Bethesda Maryland United States 20892

Sponsors and Collaborators

  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Ismail B Turkbey, M.D., National Cancer Institute (NCI)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT03354416
Other Study ID Numbers:
  • 180017
  • 18-C-0017
First Posted:
Nov 28, 2017
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 18, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Cancer Institute (NCI)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022