Clinical trial NCT03354416: Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer
Official title: Profiling of Radiological Factors in Treatment and Outcomes in Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostatic Cancer
Prostatic Neoplams
Prostatic Hyperplasia
Prostate Cancer
Cancer Of Prostate
Keywords: Imaging-Based Prognostic Markers
Multiparametric MRI (mpMRI)
Translation of Imaging into Treatment Decisions
Decision-Support System
Artificial Intelligence Research
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2017-11-28
Enrollment: 10000
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary clinical

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.

Eligibility criteria: * 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

Primary outcomes:
measure: Associations between imaging features and clinicopathological factors
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Ismail B Turkbey, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toth R, Sperling D, Madabhushi A. Quantifying Post- Laser Ablation Prostate Therapy Changes on MRI via a Domain-Specific Biomechanical Model: Preliminary Findings. PLoS One. 2016 Apr 18;11(4):e0150016. doi: 10.1371/journal.pone.0150016. eCollection 2016.
citation: Wang S, Burtt K, Turkbey B, Choyke P, Summers RM. Computer aided-diagnosis of prostate cancer on multiparametric MRI: a technical review of current research. Biomed Res Int. 2014;2014:789561. doi: 10.1155/2014/789561. Epub 2014 Dec 1.
citation: Lavery HJ, Cooperberg MR. Clinically localized prostate cancer in 2017: A review of comparative effectiveness. Urol Oncol. 2017 Feb;35(2):40-41. doi: 10.1016/j.urolonc.2016.11.013. Epub 2016 Dec 18.