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Principal Investigator: Flemming Forsberg
Organization: THOMAS JEFFERSON UNIVERSITY
Fiscal Year: 2024
Award: $562,920
Funding agency: National Cancer Institute
Prostate cancer (PCa) is the most frequently diagnosed cancer among American males, accounting for 20% of
new cancer diagnoses, but PCa is directly responsible for only 9% of cancer related deaths. PSA screening
facilitates the detection of PCa, but many of the cancers detected by PSA screening are low to intermediate
grade, resulting in overtreatment of non-aggressive PCa. Recent studies suggest an urgent need to selectively
identify “clinically significant” PCa that will result in cost-effective treatment of PCa. In the past few years,
multiparametric MRI (mp-MRI) has become the standard of care for diagnosis of aggressive PCa. Although mp-
MRI guided biopsy can selectively detect higher grade PCa lesions, several recent studies acknowledge that a
considerable number of clinically important lesions are missed by mp-MRI. Furthermore, given the high cost of
MRI, the geographic variability in the availability of MRI systems, the inexact methods used to register and fuse
MRI with ultrasound for biopsy, and the dangers of Gadolinium in patients with renal insufficiency, there is a
need for a more cost-effective, alternative to detect high-grade PCa. Recent studies have demonstrated that
contrast-enhanced ultrasound (CEUS) can selectively detect patients with “clinically significant” PCa. New
methods have been proposed to enhance conventional ultrasound detection of PCa, including subharmonic
imaging (SHI), contrast-enhanced ultrasound dispersion imaging (CUDI) and viscoelastography. The objective
of this project is to develop a system capable of a multiparametric combination of ultrasound techniques (mp-
US) for detection of “clinically significant” PCa. We will compare 3D mp-US and mp-MRI to identify significant
PCa (defined as: Gleason score ≥ 7, a single core with > 50% involvement, or > 25% of biopsy cores positive for
PCa or as Gleason grade group ≥ 2, PSA > 10 or clinical stage of cT2b or worse). The first year of the study will
be dedicated to implementation of our mp-US technique on a commercially available 3D transrectal probe, and
to adapting a MRI-based fusion/registration system to mp-US. During the second year, we will optimize mp-US
with a machine learning approach, based upon pathologic correlation with 50 radical prostatectomy patients.
The final 3 years of the study will be dedicated to a clinical trial with 300 participants suspected of having PCa.
Each participant will receive an experimental intervention in the form of biopsy of up to 3 suspicious areas
identified by transrectal ultrasound evaluation of the prostate with mp-US. For comparison, a maximum of 3
targeted biopsy cores will also be obtained from each participant, based on mp-MRI (the clinical intervention).
Following the targeted biopsy, each participant will also receive a systematic biopsy (standard of care) consisting
of 6 laterally directed biopsy cores and 6 medially directed biopsy cores. The study is powered to demonstrate
that targeted biopsy based upon mp-US is not inferior to targeted biopsy based upon mp-MRI.
Terms: <3-D><3-Dimensional><3D><Accounting><Accuracy of Diagnosis><American><Area><Base of Human Prostate><Base of the Prostate><Behavior><Biological Markers><Biopsy><Body Tissues><Cancer Detection><Cancers><Cell Communication and Signaling><Cell Signaling><Cessation of life><Clinical><Clinical Trials><Colon or Rectum><Colorectal><Contrast Agent><Contrast Drugs><Contrast Media><Core Biopsy><Core Needle Biopsy><Death><Dedications><Detection><Developing Countries><Developing Nations><Diagnosis><Disease><Disorder><Early Diagnosis><Early treatment><Echography><Echotomography><Elasticity><Engineering><European><Evaluation><Gadolinium><Gd element><Geography><Gleason Grade><Gleason Grade for Prostate Cancer><Gleason Score><Gleason Score for Prostate Cancer><Gleason Sum><Gleason-SC><Histopathology><Home><Image><Imaging technology><Industry><Intervention><Intervention Strategies><Intracellular Communication and Signaling><Kidney Failure><Kidney Insufficiency><Kinetics><Lead><Left><Lesion><Less-Developed Countries><Less-Developed Nations><Local Cancer><Localized Cancer><Localized Malignancy><Localized Malignant Neoplasm><Lung><Lung Respiratory System><MR Imaging><MR Tomography><MRI><MRIs><Machine Learning><Magnetic Resonance Imaging><Malignant Neoplasms><Malignant Tumor><Malignant Tumor of the Prostate><Malignant neoplasm of prostate><Malignant prostatic tumor><Medial><Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance><Medical Ultrasound><Meta-Analysis><Methods><Microbubbles><Morbidity><Morbidity - disease rate><NMR Imaging><NMR Tomography><Neighborhoods><Nuclear Magnetic Resonance Imaging><Ovarian><PLCO study><PLCO trial><PSA screening><PSA test><Participant><Pathologic><Patients><Pb element><Pilot Projects><Predictive Value><Prostate><Prostate CA><Prostate CA therapy><Prostate Cancer><Prostate Cancer therapy><Prostate Gland><Prostate malignancy><Prostate, Lung, Colo-rectal and Ovarian (PLCO) Cancer Screening Trial><Prostate, Lung, Colo-rectal and Ovarian Cancer (PLCO) screening trial><Prostate, Lung, Colo-rectal, and Ovarian (PLCO)><Prostate, Lung, Colo-rectal, and Ovarian Cancer Screening Trial><Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial><Prostate, Lung, Colorectal and Ovarian Cancer (PLCO) screening trial><Prostate, Lung, Colorectal, and Ovarian (PLCO)><Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial><Prostate, Lung, Ovarian (PLCO)><Prostatic Cancer><Prostatic Gland><Prostatovesiculectomy><ROC Analyses><ROC Curve><Radical Prostatectomy><Radiopaque Media><Randomized><Rectum><Renal Failure><Renal Insufficiency><Research Resources><Resources><Scanning><Scientist><Screening for Prostate Cancer><Signal Transduction><Signal Transduction Systems><Signaling><Specificity><Structure of base of prostate><System><Techniques><Third-World Countries><Third-World Nations><Time><Tissues><Transrectal Ultrasound><Ultrasonic Imaging><Ultrasonogram><Ultrasonography><Ultrasound Diagnosis><Ultrasound Medical Imaging><Ultrasound Test><Under-Developed Countries><Under-Developed Nations><Viscosity><Visualization><Zeugmatography><bio-markers><biologic marker><biological signal transduction><biomarker><cancer diagnosis><clinical significance><clinically significant><colorectum><contrast enhanced><cost><cost effective><cost effective intervention><cost effective therapy><cost effective treatment><detect prostate cancer><detection method><detection procedure><detection technique><developing country><developing nation><diagnostic accuracy><diagnostic ultrasound><early detection><early therapy><editorial><heavy metal Pb><heavy metal lead><homes><imaging><improved><industrial partnership><industry partner><industry partnership><interventional strategy><machine based learning><male><malignancy><men><mortality><neoplasm/cancer><new marker><new technology><novel><novel biomarker><novel marker><novel technologies><over-treatment><overtreatment><pilot study><portability><prostate cancer detection><prostate cancer early detection><prostate cancer treatment><prostate specific antigen screening><prostate specific antigen test><prostate, lung, colorectal and ovarian cancer screening cohort><prostate, lung, colorectal, and ovarian cancer screening><pulmonary><randomisation><randomization><randomly assigned><receiver operating characteristic analyses><receiver operating characteristic curve><screening><screening program><screenings><socio-economic><socio-economically><socioeconomically><socioeconomics><sonogram><sonography><sound measurement><standard of care><technology/technique><three dimensional><treatment program><ultrasound><ultrasound imaging><ultrasound scanning><viscoelasticity>