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This is a single arm study to evaluate feasibility of UroNAV Ablation system aided cryo-ablation treatment of low and intermediate risk, organ-confined prostate cancer. UroNav is a stereotaxic accessory for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (US) images and the ability to fuse and register these images with those from other imaging modalities such as Magnetic Resonance (MR), Computed Tomography, etc. It also provides the ability to display a simulated image of a tracked insertion tool on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument. DynaCAD 5.0 is an image analysis and planning system that will provide off station, pre planning and review of interventional study data. It interfaces with the Uronav 4.0 fusion guidance system.

Focal ultrasound guided cryoablation using uroNav system Version 4.0 and Dyna CAD software version 5.0.

Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance

Ardeshir R Rastinehad, DO

Cynthia Knauer, RN

Peter Tricarico

Ardeshir Rastinehad, DO

The purpose of this research study is to determine the safety and feasibility of using the UroNav software and DynaCAD software for planning and treating prostate cancer as an add on to the already approved workflow of using ultrasound only during the cryoablation of the prostate. The software application may aid doctors in locating a prior biopsy proven cancer location from the UroNav biopsy that patients previously had and then use that information to guide the treatment.

This is a single-center, prospective, single arm study to evaluate feasibility of UroNAV Ablation system aided cryo-ablation treatment of low and intermediate risk, organ-confined prostate cancer. All subjects will be treated and then followed up clinically for up to 24 months to evaluate any procedure or device related adverse events as well as to assess efficacy endpoints of the study. Additional data related to quality of life of treated subjects will also be collected

Focal US-guided Cryo-ablation Using DynaCAD / UroNAV Preplanning / Guidance of Intermediate Risk Prostate Cancer

A Study to Evaluate the Safety and Efficacy of Focal US Guided Cryo-ablation Using DynaCAD / UroNAV Preplanning / Guidance of Locally Confined Low to Intermediate Risk Prostate Cancer

Incidence and severity of device/treatment related complications from treatment day visit through 24 month follow up.

Primary effectiveness analyses will be based on the 12-month biopsy results. Post-treatment PSA, non-perfused volume (NPV) by multi-parametric MRI, and EPIC - 26 (The Expanded Prostate Cancer Index Composite) questionnaire results through Month 24 visit will be summarized as secondary measures of effectiveness.

Philips Healthcare

Northwell Health

Associate Professor of Urology and Radiology, Vice Chair of Urology at Lenox Hill Hospital, System Director for Prostate Cancer

Prostate MRI

Andreas Hötker, MD

This study aims to assess the value of ultra-fast MRI sequences in the assessment of prostate cancer, compared to the full multiparametric/biparametric protocol as the clinical standard.

Prostate cancer is the second most common type of cancer among men and the fifth leading cause of cancer-related deaths globally. Magnetic resonance imaging (MRI) has become an integral part of the clinical assessment of prostate cancer and is a valuable tool to identify target lesions for subsequent biopsy, perform local tumor staging, provide information on active surveillance approaches, and might also be eligible for prostate cancer screening.

To standardize the interpretation and reporting in prostate MRI, the PI-RADS (Prostate Imaging-Reporting and Data System) scoring system has been developed. PI-RADS has played a crucial role in the widespread adoption of prostate MRI among radiologists and urologists worldwide and has also become an essential part of national and international clinical guidelines. This has resulted in a notable surge in the number of prostate MRI examinations conducted in recent years, and is expected to further increase over the next years. The present PI-RADS guideline provides comprehensive technical instructions on the acquisition of prostate MRI leading to the acquisition of a multiparametric MRI (mpMRI) that typically requires around 30 minutes of scan time.

As healthcare systems around the world face increasing demand and limited resources, there is a need to identify efficient and cost-effective ways to diagnose and treat prostate cancer. Efforts have been made to reduce the duration and expenses associated with prostate MRI acquisition and interpretation, leading to a biparametric MRI (bpMRI, exclusion of contrast-enhanced sequences) with a shortened protocol compared to the conventional mpMRI. Several studies have demonstrated the high diagnostic accuracy of abbreviated prostate MRI for detecting and even staging prostate cancer in comparison to traditional full mpMRI. The accelerated protocols have therefore the potential to improve efficiency and patient comfort, to reduce healthcare costs and make this technique accessible to more men. Nevertheless, even these shortened protocols accrue a scan time of about 15-20 minutes. Recent developments in MRI technique now allow for even faster image acquisitions, but more research is necessary to fully elicit the advantages and limitations of accelerated or even ultra-fast prostate MRI protocols (scan time of \< 5 min) before incorporating them into routine clinical practice.

The purpose of this study is therefore to further explore ultra-fast bpMRI compared to conventional full mpMRI of the prostate to gain valuable insights into the diagnostic performance, feasibility and clinical utility of this emerging imaging technique and consequently optimize prostate cancer management.

Value of Ultra-fast Prostate MRI in Prostate Cancer

Value of Ultra-fast Biparametric MRI in the Assessment of Prostate Cancer

Diagnostic accuracy of ultrafast bpMRI of the prostate

University of Zurich

Prostate MRI. Blood and urine biomarkers. Both prior to biopsy. Tissue samples during prostatectomy.

MRI of the prostate prior to prostate biobsy

Hannu J Aronen, M.D. Ph.D.

Peter J Boström, M.D., Ph.D

This study will enroll 200 men with clinical suspicion of prostate cancer due to higher serum level of PSA than 2.5 ng/ml or abnormal digital rectal examination.

Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) at 3 Tesla (T) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer.

Targeted TRUS guided biopsy based on MRI findings will be performed in addition to routine twelve core TRUS biopsy.

Moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer.

Specific aims of the current study are as follows:

i) To determine the sensitivity, specificity and accuracy of a novel rapid anatomical MRI and DWI at 3T magnetic field for the detection of prostate cancer in correlation with systematic TRUS guided biopsy

ii) To determine the sensitivity, specificity and accuracy of selected serum, urine and tissue biomarkers for detection of prostate cancer

iii) To develop statistical model for diagnosis of prostate cancer incorporating findings of a novel rapid MRI/DWI and selected biomarkers

iv) To assess the applicability of TRUS guided prostate biopsy based on MRI finding in patient with no previous prostate biopsy

v) To develop and validate an imaging protocol which will become the standard protocol for prostate imaging at Medical Imaging Centre of Southwest Finland (VSKK) / TYKS, Turku, Finland.

Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers

Serum and urine samples before prostate biopsy and tissue samples during prostatectomy

Turku University Hospital

Professor, Chief Physician

Men who harbor known germline mutations that have been associated with an increased risk of prostate cancer and aggressive disease (e.g. BRCA2, ATM, PALB2, etc.) with or without a known family history of prostate cancer.

Men who harbor significantly increased disease risk based upon genetic risk score (GRS) value \>1.5 with or without a known family history of prostate cancer.

Men with a family history of prostate cancer in at least one sibling, father, uncle, or grandfather but no known increased genetic risk of prostate cancer (has no pathogenic or likely pathogenic mutation along with a low genetic risk score (GRS\<1.5).

No known germline mutation, low genetic risk score (GRS \<1.5), and no known family history of prostate cancer.

Group placement is determined by GRS score, Family history, and germline testing

Scott Eggener, MD

Teresa Barry

The purpose of this study is to determine whether or not Magnetic Resonance Images (MRI) will identify high-grade cancers earlier and more frequently in men at high risk of developing prostate cancer.

In this study the study team hypothesizes MR images will identify high-grade cancers earlier and more frequently in men at high risk of developing prostate cancer. Subjects will receive gadolinium (intravenous contrast agent) as part of their research MRI exam. While the deposition of gadolinium (Gd) has been demonstrated in numerous studies, the clinical consequences of Gd deposition are unknown. Gd enhanced MRI scans provide crucial medical information regarding prostate and prostate cancer imaging and contrast-enhanced images are a component of all guidelines and the PIRADS scoring system. The study team will compare baseline prostate MR images of men at high risk of developing prostate cancer to those without an identifiable predisposition and evaluate the role of a GRS in screening men with at elevated risk of being diagnosed with prostate cancer.

MRI Screening in Men at High Risk of Developing Prostate Cancer

MRI results will be collected every 3 years for 15 years until high grade prostate cancer is detected as defined as Gleason greater than or equal to 7 (Grade Group 2).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Focal US-guided Cryo-ablation Using DynaCAD / UroNAV Preplanning / Guidance of Intermediate Risk Prostate Cancer	NCT04656678	Prostate Cancer Prostate Diseas...	Cryo-ablation U...	45 Years -	Northwell Health
Value of Ultra-fast Prostate MRI in Prostate Cancer	NCT05903781	Prostate Cancer	Prostate MRI	18 Years -	University of Zurich
Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers	NCT02844829	Prostate Cancer	Prostate MRI	40 Years - 85 Years	Turku University Hospital
MRI Screening in Men at High Risk of Developing Prostate Cancer	NCT05608694	Prostate Cancer...	Prostate MRI	18 Years -	University of Chicago
Value of Ultra-fast Prostate MRI in Prostate Cancer	NCT05903781	Prostate Cancer	Prostate MRI	18 Years -	University of Zurich
Improved Prostate Cancer Diagnosis - Combination of Rapid Prebiopsy Magnetic Resonance Imaging and Biomarkers	NCT02844829	Prostate Cancer	Prostate MRI	40 Years - 85 Years	Turku University Hospital

Spots Global Cancer Trial Database for prostate mri

Every month we try and update this database with for prostate mri cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.