no interventions will be performed (observational)
no interventions will be performed (observational): Not applicable. (no interventions will be performed with this observational study
Study summary
Discover, optimize, standardize, and validate clinical-trial measures and biomarkers used to diagnose and differentiate cardiovascular, oncologic, neurologic, and other diseases and disorders. Specifically, our research study endeavors to improve disease and disorder diagnosis to the earliest clinical states, in preclinical states, and to develop ensemble multivariate biomarker risk scores leading to cardiovascular, oncologic, neurologic, and other diseases and disorders.
Additionally, the study aims to:
* Evaluate data analysis techniques to improve diagnostic accuracy and reduce time to diagnosis.
* Evaluate data analysis techniques to improve risk stratification for participants through machine learning algorithms.
* Direct participants to relevant and applicable clinical trials.
Eligibility
Sex
MALE
Min age
45 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
Treatment Naïve patients:
* Male, 45 years of age or older.
* Diagnosis of prostate adenocarcinoma.
* Clinical stage T1c or T2a.
* Gleason score of 7 (3+4 or 4+3) or less.
* Three or fewer biopsy cores with prostate cancer.
* PSA density not exceeding 0.375.
* One, two, or three tumor suspicious regions identified on multiparametric MRI.
* Negative radiographic indication of extra-capsular extent.
* Karnofsky performance status of at least 70.
* Estimated survival of 5 years or greater, as determined by treating physician.
* Tolerance for anesthesia/sedation.
* Ability to give informed consent.
* At least 6 weeks since any previous prostate biopsy.
* MR-guided biopsy confirmation of one or more MRI-visible prostate lesion(s) with Gleason score of 7 (3+4 or 4+3) or less.
Salvage candidates will be accepted upon physician referral.
Exclusion Criteria:
* Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
* Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater
* History of other primary non-skin malignancy within previous three years.
* Diabetes
* Smoker
Primary outcome measure(s)
Prostate cancer Gleason score — Up to 5 years after treatment Measure a patient's prostate cancer Gleason score for patients with a prostate cancer diagnosis and record the measurement again at 3, 6, 9 months and annually for 5 years after treatment. We will use the pathology report submitted by the pathologist. The Gleason Score ranges from 1-5 and describes how much the cancer from a biopsy looks like healthy tissue (lower score) or abnormal tissue (higher score).
Prostate cancer ISUP grade group — Up to 5 years after treatment Measure a patient's prostate cancer ISUP grade group for patients with a prostate cancer diagnosis and record the measurement again at 3, 6, 9 months and annually for 5 years after treatment. We will use the pathology report submitted by the pathologist. The International Society of Urological Pathology (ISUP) guidelines grades the cancer between 1 and 5 depending on the Gleason score. The lower the grade the less likely the cancer is to spread.
Prostate cancer staging parameters — Up to 5 years after treatment TNM stage and metastasis-free survival, documentation of tumor, lymph node and osseous involvement
Prostate cancer specific mortality — Up to 5 years Proportion of men who expire directly due to prostate cancer
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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