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 : November 5, 2020
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.
To gather data about the radiological and clinical course of prostate cancer. To study imaging-based biomarkers of prostate cancer.
Men ages 18 and older with diagnosed or suspected prostate cancer
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|
- 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.
- 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.
- 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.
- 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 Type :||Observational|
|Estimated Enrollment :||10000 participants|
|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|
1/ Cohort 1
Subjects with a diagnosis of prostatic cancer or suspicious for prostatic cancer lesions.
- Associations between imaging features and clinicopathological factors [ Time Frame: 10 years ]Radiological profiling of patients with prostate cancer
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
|Contact: Yolanda McKinney, R.N.||(240) firstname.lastname@example.org|
|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|
|Principal Investigator:||Ismail B Turkbey, M.D.||National Cancer Institute (NCI)|