Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Aggression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Men who have been recently diagnosed with high risk prostate cancer (Gleason score 7 and above) and who choose prostate removal for their cancer treatment will undergo Magnetic Resonance Spectroscopy Imaging (MRSI) with rectal probe at the Oregon Health \& Science University's Advanced Imaging Research Center.

Men who have been recently diagnosed with low risk prostate cancer (Gleason score 7 \[3+4\] and below) and who choose prostate removal for their cancer treatment will undergo Magnetic Resonance Spectroscopy Imaging (MRSI) with rectal probe at the Oregon Health \& Science University's Advanced Imaging Research Center.

Magnetic Resonance Spectroscopy Imaging with rectal probe

Jackilen Shannon, PhD

Jonathan Q Purnell, MD

A prostate cancer diagnosis starts a list of events that often leads to fast-moving treatment, thought by many to result in vast over-treatment of this disease. So, discovery of different diagnostic methods that allow clinicians to identify slow-growing from potentially fast-growing disease prior to or at the time of prostate biopsy could result in early and suitable treatment for men at greatest risk, while greatly decreasing the number of biopsies, surgical procedures, hormonal and chemotherapeutic treatments, cost, and patient worry, for those with more slow-growing disease.

Blood, Urine, Prostatic fluid and Prostatectomy tissue

Magnetic Resonance Spectroscopic Imaging Study of Prostatic Fats to Distinguish the Difference Between High and Low Risk Prostate Cancer

Imaging Prostatic Lipids to Distinguish Aggressive Prostate Cancer

To quantify the association between key metabolic intermediates involved in lipid metabolism, mitochondrial function, inflammation, and apoptosis in prostatectomy samples and fatty acid synthase protein expression, intraprostatic lipid and tumor aggressiveness.

Determine the correlation between the amount of intraprostatic lipid using 1H (proton) magnetic resonance spectroscopic imaging (MRSI) with an endorectal coil obtained prior to prostatectomy with fatty acid synthase protein expression measured in benign and cancer tissue from prostatectomy samples.

Identify the association between fatty acid synthase protein expression in prostatectomy samples, intraprostatic lipid as measured by 1H MRSI, and prostate tumor aggressiveness.

United States Department of Defense

Portland VA Medical Center

Oregon Health and Science University

OHSU Knight Cancer Institute

Principal Investigator

Symptoms and General Pathology

Nervous System Diseases

Recurrence

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

Patients who underwent MRI with confirmed pathology data (either biopsy or prostatectomy)

Magnetic Resonance Imaging

Daniele Regge, MD

Simone Mazzetti, PhD

Daniele Regge

Manolis Tsiknakis

Nickolas Papanikolau

Kostantinos Marias

In Europe, prostate cancer (PCa) is the second most frequent type of cancer in men and the third most lethal. Current clinical practices, often leading to overdiagnosis and overtreatment of indolent tumors, suffer from lack of precision calling for advanced AI models to go beyond SoA by deciphering non-intuitive, high-level medical image patterns and increase performance in discriminating indolent from aggressive disease, early predicting recurrence and detecting metastases or predicting effectiveness of therapies. To date efforts are fragmented, based on single-institution, size-limited and vendorspecific datasets while available PCa public datasets (e.g. US TCIA) are only few hundred cases making model generalizability impossible.

The ProCAncer-I project brings together 20 partners, including PCa centers of reference, world leaders in AI and innovative SMEs, with recognized expertise in their respective domains, with the objective to design, develop and sustain a cloud based, secure European Image Infrastructure with tools and services for data handling. The platform hosts the largest collection of PCa multi-parametric (mp)MRI, anonymized image data worldwide (\>17,000 cases), based on data donorship, in line with EU legislation (GDPR). Robust AI models are developed, based on novel ensemble learning methodologies, leading to vendor-specific and -neutral AI models for addressing 8 PCa clinical scenarios.

To accelerate clinical translation of PCa AI models, we focus on improving the trust of the solutions with respect to fairness, safety, explainability and reproducibility. Metrics to monitor model performance and a causal explainability functionality are developed to further increase clinical trust and inform on possible failures and errors. A roadmap for AI models certification is defined, interacting with regulatory authorities, thus contributing to a European regulatory roadmap for validating the effectiveness of AI-based models for clinical decision making.

An AI Platform Integrating Imaging Data and Models, Supporting Precision Care Through Prostate Cancer's Continuum

Fundacao Champalimaud

Stichting Katholieke Universiteit

Fundacion Para La Investigacion Hospital La Fe

University of Pisa

Institut Paoli-Calmettes

Hacettepe University

FUNDACIO INSTITUT D'INVESTIGACIO BIOMEDICA DE GIRONA DOCTOR JOSEP TRUETA

João Carlos Costa - Diagnóstico por Imagem, S.A.

National Cancer Institute (NCI)

General Anti-Cancer and Oncological Hospital of Athens St. Savvas

Royal Marsden NHS Foundation Trust

QS INSTITUTO DE INVESTIGACION E INNOVACION SL

IDRYMA TECHNOLOGIAS KAI EREVNAS

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

THE GENERAL HOSPITAL CORPORATION

BIOTRONICS 3D LIMITED

ADVANTIS MEDICAL IMAGING SINGLE MEMBER PC

QUIBIM SOCIEDAD LIMITADA

UNIVERSITAT WIEN

Fondazione del Piemonte per l'Oncologia

Non-invasive blood based immunogenomic assay that targets RNA sequencing to identify disease and disease aggressiveness

Subtraction Normalized Expression of Phagocytes Blood Test

Jessica DeHart

Bridget Makhlouf

Patrick Keating

Howard Korman, MD

A multi-center, prospective active surveillance registry trial assessing the performance of a non-invasive blood test for indolent prostate cancer disease management.

The analysis population is defined as all the set of de-identified patient results received from the practices who met the inclusion / exclusion criteria. A target recruitment of 2000 subjects with an expected loss of 20% (400 subjects) and an overall event rate of 30% (480 subjects of 1600) will result in 480 cases and 1120 controls, where cases are defined as those patients with NCCN unfavorable intermediate risk or worse disease. With a significance level alpha of 0.05, the number of cases above will result in a statistical power (1-ß=0.2) of at least 80% to show a significant increase in performance of the full assay over clinical variables alone, assuming that performance characteristics are similar to those observed in a retrospective, independent training cohort and that the patients in the SAFELY cohort resemble this same training population.

Three tubes of blood:

Two 8ml CPT One 4ml SST

Prostate Biopsy slides

Active Surveillance SNEP Assay Registry Trial for Prostate Cancer

A Multi-center, Prospective Active Surveillance Registry Trial Assessing the Performance of a Non-invasive Immunogenomic Blood Test for Indolent Prostate Cancer Disease Management.

Collect information from repeat biopsy including any increase in gleason grade, increase in number of cores positive, and increase in % cross sectional surface area involved by tumor from the repeat biopsy.

On an annual basis, collect follow-up frequency data for each patient including optional repeat blood testing, repeat biopsy data, disease management decisions, and disease progression.

Immunis.AI

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Magnetic Resonance Spectroscopic Imaging Study of Prostatic Fats to Distinguish the Difference Between High and Low Risk Prostate Cancer	NCT01780701	Prostate Cancer	Magnetic Resona...	21 Years -	OHSU Knight Cancer Institute
Magnetic Resonance Spectroscopic Imaging Study of Prostatic Fats to Distinguish the Difference Between High and Low Risk Prostate Cancer	NCT01780701	Prostate Cancer	Magnetic Resona...	21 Years -	OHSU Knight Cancer Institute
Magnetic Resonance Spectroscopic Imaging Study of Prostatic Fats to Distinguish the Difference Between High and Low Risk Prostate Cancer	NCT01780701	Prostate Cancer	Magnetic Resona...	21 Years -	OHSU Knight Cancer Institute
An AI Platform Integrating Imaging Data and Models, Supporting Precision Care Through Prostate Cancer's Continuum	NCT05384002	Prostate Cancer Prostate Cancer... Prostate Cancer... Prostate Cancer...	Magnetic Resona...	18 Years - 85 Years	Fondazione del Piemonte per l'Oncologia
Active Surveillance SNEP Assay Registry Trial for Prostate Cancer	NCT04052048	Prostate Cancer...	Subtraction Nor...	40 Years - 80 Years	Immunis.AI

Spots Global Cancer Trial Database for prostate cancer aggressiveness