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Trial record 48 of 59 for:    Recruiting, Not yet recruiting, Available Studies | "Prostatic Hyperplasia"

Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer

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ClinicalTrials.gov Identifier: NCT03354416
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( 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


Condition or disease
Prostatic Cancer Prostatic Neoplams Prostatic Hyperplasia Prostate Cancer Cancer Of Prostate

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 Program (MIP) for identification of imaging-based prognostic markers in prostate cancer.

Eligibility:

  • Patients 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 or suspected of prostate cancer obtained during visits to NCI and long-term follow up will be collected and analyzed.


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort
Cohort 1
Subjects with a diagnosis of prostatic cancer or suspicious for prostatic cancer lesions.



Primary Outcome Measures :
  1. Radiological profiling of patients with prostate cancer [ Time Frame: 10 years ]
    Radiological profiling of patients with prostate cancer



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a diagnosis of prostatic cancer or suspicious for prostatic cancer lesions.
Criteria
  • INCLUSION CRITERIA:
  • Patients 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354416


Contacts
Contact: Yolanda McKinney, R.N. (301) 443-6913 ymckinney@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ismail B Turkbey, M.D. National Cancer Institute (NCI)

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03354416     History of Changes
Other Study ID Numbers: 180017
18-C-0017
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 7, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Imaging-Based Prognostic Markers
Multiparametric MRI (mpMRI)
Translation of Imaging into Treatment Decisions
Decision-Support System
Artificial Intelligence Research

Additional relevant MeSH terms:
Prostatic Neoplasms
Hyperplasia
Prostatic Hyperplasia
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Pathologic Processes