Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate

MRI thermometry

The objective of this project is to offer a very innovative solution for measuring temperature variations in MRI on the prostate. Multiparametric prostate MRI can detect target lesions, on which targeted biopsies are then performed. The use of a temperature mapping on the prostate in MRI would make it possible to evaluate a focal treatment of the prostate by laser under MRI guidance

Prostate MRI has become the benchmark examination to search for tumor targets, thanks to a multi-parameter protocol, including T2 sequences, diffusions, and T1 with gadolinium injection. A PIRADS prognostic score is performed on the different sequences and if the lesions are at high risk of malignancy (PIRADS 4 and 5), a targeted biopsy is performed. Minimally invasive ablations called focal treatments are developing more and more: HIFU, cryotherapy, laser, etc. Ultrasound remains the most widespread examination due to its availability, but with less sensitivity than MRI. Ablations are performed under ultrasound with fusion of MRI images In order to assess the ablation area under MRI, the measurement of temperature variations appears necessary to verify the effectiveness of ablation and the lesion volume. Temperature maps are feasible in cardiac MRI during radiofrequency. The thermal mapping MRI sequence is performed in cardiac MRI at the IHU in Bordeaux.

MagneThermoPro : Magnetic Resonance Thermography of Human Prostate

the evaluation of the signal on the thermometry sequence

temperature variance measurements in a region of interest of the prostate

University Hospital, Bordeaux

Biopsy-naive men undergoing MRI for suspected prostate cancer via the Norwegian standardized care pathway. The MRI images will then be evaluated by the radiologist and a machine-learning based diagnosis and detection system.

After referral for suspected prostate cancer, the patient is scanned with magnetic resonance imaging (MRI) in accordance with guidelines of the standardized healthcare pathway. For consenting patients, the images are interpreted in two ways: first, in the conventional manner, i.e., manually by a radiologist, to determine whether clinically significant cancer is suspected. If so, the radiologist will delineate the suspicious lesions. In the second approach, the software will perform the same task as the radiologist, but automatically. If either or both interpretations point to significant cancer, the patient will be sent for targeted biopsy sampling. Histopathologic evaluation of the samples will then determine whether significant cancer is present in each of the targeted lesions (delineated by the radiologist, software, or both).

Automatic image analysis

Tone Frost Bathen, Prof.

Sverre Langørgen, MD

To perform a traditional feasibility clinical investigation, as defined in ISO 14155:2020, to investigate preliminary feasibility, safety, and clinical performance information of a near-final design of the investigational software. This will be performed through a prospective clinical study on biopsy naïve men with suspected prostate cancer examined with MRI at St. Olavs Hospital, Trondheim, Norway, in order to adequately plan an appropriate pivotal clinical investigation.

In this prospective study, after referral for suspected prostate cancer, the patient is scanned with magnetic resonance imaging (MRI) in accordance with guidelines of the standardized healthcare pathway. For consenting patients, the images are interpreted in two ways: first, in the conventional manner, i.e., manually by a radiologist, to determine whether clinically significant cancer is suspected. If so, the radiologist will delineate the suspicious lesions. In the second approach, the software will perform the same task as the radiologist, but automatically. If either or both interpretations point to significant cancer, the patient will be sent for targeted biopsy sampling. Histopathologic evaluation of the samples will then determine whether significant cancer is present in each of the targeted lesions (delineated by the radiologist, software, or both).

Feasibility is evaluated by measuring the overall failure rate of the software. This is measured by the technical performance log automatically generated by the software, which records all errors and failures during the study. If the record showed an overall failure rate less than 10% across all subjects, the software will be considered feasible.

The safety of the software is evaluated by the records of the serious adverse device effects (SADEs) of the software during the study. The software will be considered safe with no occurrence of death or serious injury.

The results of the histopathological evaluation will be used to evaluate the performance of the investigational software. This allows comparisons to be made between results obtained with the traditional manual approach alone, with the software alone, and with the manual approach assisted by the software. Statistical analysis will be performed to determine if there are significant differences and if the software adds value.

PROVIZ - a Machine Learning Software, to Support Targeting of Prostate Biopsies on MR Images in Biopsy-naive Patients

A Proof-of-technology, Pilot, Prospective Clinical Study to Investigate the Feasibility and Performance of PROVIZ-a Radiomics-based Machine Learning Software, to Support Targeting of Prostate Biopsies on MRI Images in Biopsy-naive Patients

The percentage of occurrence of a technical problem in the investigational software that hinders its use is less than 10% across all subjects.

There are no death or serious harm associated with an adverse device effect (ADE) of the investigational software.

Comparable preliminary detection rate of clinically significant prostate cancer lesions from the software to the radiologist.

St. Olavs Hospital

Norwegian University of Science and Technology

different needle size for prostate biopsy

Fabio F. Zattoni, MD, PhD

Fabio Zattoni, MD, PhD

Filippo Carletti, MD

Differences in terms of diagnostic capability and side effects related to the needle caliber used for prostate biopsy sampling in patients with suspected prostate cancer

To assess whether a larger caliber (16G) prostate biopsy needle increases the diagnostic capability of prostate neoplasia compared to a smaller caliber (18G) needle, while keeping perioperative complications constant.

Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?

AOP2780 - Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?

The primary outcome measure involves assessing the total number of biopsies, including both random and fusion-targeted approaches, that reveal the presence of prostate cancer.

The primary outcome measure focuses on the number and the detection rates of random and fusion-target biopsies revealing clinically significant prostate cancer aof clinically significant prostate cancer (defined as ISUP \>=2) between 16-gauge and 18-gauge biopsy needles.

Neoplasia/core ratio, indicates the ratio of neoplastic tissue to healthy tissue within biopsy cores obtained through both 16 and 18 gauge biopsies for prostate cancer diagnosis. By analyzing this ratio, investivators seek to identify differences in diagnosis across the two different sizes

The validated pain questionnaire employed in this study is designed to comprehensively assess the intra- and perioperative pain (following 7 days) experienced by patients undergoing prostate biopsy procedures with 18G and 16G needles. The visual analog scales "VAS" is a standardized validated questionnaire, a horizontal line, where one end represents "1 - no pain" and the other end represents "10 - worst possible pain." Patients are asked to mark on the line the point that best represents the intensity of their pain.

By tracking the number of hospitalizations occurring at both 30 and 60 days post-procedure among patients undergoing prostate biopsy within these specific time frames, researchers seek to assess the short-term post-procedural outcomes and potential complications associated with the biopsy procedure. These hospitalization data will provide information into the safety profile and healthcare utilization patterns following prostate biopsy, aiding in the optimization of patient care and risk management strategies.

Intraoperative complications refer to adverse events occurring during the biopsy procedure itself, while perioperative complications encompass those arising in the immediate post-procedural period. These complications may include but are not limited to bleeding, infection, urinary retention, and vasovagal reactions. By documenting these complications, investigators will evaluate the safety profile and potential risks associated with each needle gauge, thereby informing clinical decision-making and optimizing patient outcomes.

University Hospital Padova

MD, Phd

A standard transrectal prostatic biopsy will be performed to both groups. To the group with suspicious lesions in the MRI (PI-RADS 3-5), an added directed cognitive fusion biopsy will be performed.

fusion cognitive prostate biopsy

BARAA NAKDALI KASSAB

The goal of this prospective observational study is to evaluate the diagnostic precision of the Biparametric Magnetic Resonance Imaging (bpMRI) in the detection of clinically significant prostate cancer (PCa) in patients with biochemical suspicion of prostate cancer with PSA (Prostate Specific Antigen) \> 4 ng/mL and a normal digital rectal examination and without a biopsy previous to the MRI. Secondary aims are:

* Determine the validity as a diagnostic test of the first directed transrectal prostatic biopsy (cognitive fusion) versus systematic biopsy of 12 cylinders in patients with suspicious lesions in the bpMRI.
* Develop a predictive nomogram that permits the reduction of the number of prostatic biopsies performed to patients with a low suspicion of prostate cancer in the bpMRI.

In Spain, PCa is the most common cancer independently from gender and the third cause of death in man, below lung and colorectal cancer. Incidence and mortality increase progressively as age increases, hence, due to an older population, this is an outstanding sociosanitary concern.

PCa generally is asymptomatic, diagnosis is based on prostate biopsy in man with an elevated Prostate Specific Antigen (PSA) in blood test and/or a pathologic digital rectal examination.

Multiparametric Magnetic Resonance Imaging (MRImp) plays an important role in the diagnosis. It allows the visualization of the tumor, it values its agresitivity with a scale named "Prostate Imaging-Reporting and Data System" (PI-RADS v2 scale), and permits a directed biopsy to the suspicious lesion.

This tecnique is expensive and very uncomfortable for the patient due its duration (40 minutes) and because it uses intravenous (iv) contrast. Due to these reasons, it is difficult to assume by the sanitary system to perform this technique to every patient with PCa suspicion.

Biparametric MRI emerges as an alternative with a new protocol, performed with less image sequences (T2 and diffusion), cheaper, lasting less (just 15 minutes), and without the administration of iv contrast. Thus, this technique is more assumable by a public sanitary system.

Cognitive Fusion Prostate Biopsy With Biparametric Magnetic Resonance in the Detection of Prostate Cancer

Determine the Validity as a Diagnostic Test of the Transrectal Prostate Biopsy With Cognitive Fusion Through Biparametric Magnetic Resonance in the Detection of Non-palpabe Prostate Cancer

evaluate the diagnostic precision of the Biparametric Magnetic Resonance Imaging (bpMRI) in the detection of clinically significant prostate cancer in patients with biochemical suspicion of prostate cancer (Prostate Specific Antigen in blood test \> 4 ng/mL) with a normal digital rectal examination and without a biopsy previous to the MRI

Determine the validity as a diagnostic test of the first directed transrectal prostatic biopsy (cognitive fusion) versus systematic biopsy of 12 cylinders in patients with suspicious lesions in the bpMRI.

José Joaquín Mira

Director

Subjects with MRI prior prostate biopsies

Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device

magnetic resonance imaging, Siemens

Markku Vaarala, MD PhD

The purpose of the study is to evaluate the usefulness of 3-T magnetic resonance imaging (MRI) in the evaluation of suspected prostate cancer. Men with suspected prostate cancer based on serum prostate-specific antigen antigen (PSA) value are included. Men are randomized to pre-biopsy MRI or no MRI groups in ratio 1:1. Standard transrectal ultrasound guided biopsies will be taken in addition to extra biopsies from lesions suspicious based on MRI evaluation. Hypothesis is that more prostate cancers will be found after MRI evaluation.

Evaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer

Evaluation of Diagnostic Value of 3-T MRI in Suspected Prostate Cancer

The number of patients with confirmed prostate cancer among men with MRI performed before biopsies are compared to the number of patients with prostate cancer confirmed in prostate biopsies without MRI. The number patients with prostate cancer are counted as total from cancers detected in random biopsies and in biopsies targeted based on suspicious MRI findings in MRI group, and from random biopsies in no MRI group.

The number of biopsies with histology confirming prostate cancer are compared between MRI and no MRI groups. This measure will clarify if prostate cancer can be diagnosed more accurately, i.e. more biopsies with confirmed prostate cancer, after MRI. Ten or 12 biopsies will be taken from prostates below 30 grams, or equal or above 30 grams, respectively.

Number of clinically significant prostate cancers detected with and without MRI. Clinically significant prostate cancer is determined by the Gleason grading and be the number of cancer-positive biopsy cores.

Oulu University Hospital

University of Oulu

MD, PhD

Subjects with MRI prior prostate biopsies

magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device

MRI Done

no MRI

Total

Age, Continuous

Sex: Female, Male

Finland

Region of Enrollment

Serum prostate-specific antigen level

Population with protocol violations excluded

Chief urologist Markku Vaarala

Number of Prostate Cancer Diagnoses in MRI and no MRI Groups

Number of Positive Biopsies in MRI and no MRI Groups

Proportion of Clinically Significant Prostate Cancers Detected in MRI and no MRI Groups

Overall Study

Patients will have a standard of care MRI, then consent to study participation and have an upright MRI.

Patients will consent to participate in the study, then do two MRIs in random order.

Indomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T strength

Upright MRI

Standard MRI

Monali Fatterpekar, Ph.D.

Cristina Pasat-Karasik

Ash Tewari, MD

This is an investigator initiated study to test the efficacy of an upright MRI (Magnetic Resonance Imaging) for the screening of prostate cancer. The purpose of this study is to compare Upright MRI as a technique to PSA (Prostate Specific Antigen) and current MRI imaging. It will take place at Mount Sinai Hospital, and last for a total of about 5 years. Eligible patients will be determined by the urologist. The target population is men who are at risk for prostate cancer, as determined by the urologist. Diagnostic criteria will include elevated PSA and an abnormal digital rectal exam (DRE). After patients are screened and determined eligible, they will be asked to have a seated MRI using the Indomitable Magnetic Resonance Imaging Scanner, Ex vivo magnetic resonance imaging using 0.6 T strength, as well as a standard of care closed 3T MRI. After each scan, the patient will be given a series of questionnaires to assess their comfort level during the scan. Patients will be followed every 6 months after completion of (or early withdrawal from) study enrollment until 5 years.

Prostate cancer (PCa) is the second most common cancer among men in the United States, with over 180,000 new cases diagnosed in 2016. This commonality implies that set standards need to be set and devise effective tools to screen and diagnose prostate cancer. Today, prostate specific antigen (PSA) test is the most widely adopted screening method for PCa. Since its introduction in 1979, it has helped in earlier diagnosis of PCa and has had a marked shift on the stage at which PCa is identified. PSA, although popular as a screening tool, has several shortcomings. It is organ-specific rather than cancer-specific, which means that its values can be elevated even for non-malignant conditions . Indeed, PSA based screening has reported positive predictive value as low as 30% (PSA cutoff \>4.0 ng/dL) for detecting prostate cancer and an over diagnosis rate of 50%, which leads to unnecessary biopsies and aggressive treatments of men with clinically indolent (insignificant) disease.

Current diagnostic pathway of prostate cancer requires men with elevated PSA and abnormal Digital Rectal exam to undergo a Trans Rectal Ultra Sound (TRUS) guided biopsy. TRUS is a blind-systematic biopsy, which randomly samples prostate tissue. This can lead to missing or under-diagnosing clinically significant cancer and over-diagnosing clinically insignificant disease. TRUS biopsy is itself associated with morbidity, mainly in the form of hematuria, hematospermia, pain, urinary retention and sometimes can cause life-threatening sepsis.

Many of the PSA screened detected prostate cancers detected on TRUS are clinically insignificant and even if left untreated have little to no clinical impact on an individual's remaining life. Overtreatment resulting from over diagnosis often leads to side effects like erectile dysfunction (approx. 60%) from radical therapy and urinary incontinence.

Prostate Biopsy Cores and/or Punch Cores from Radical Prostatectomy Specimen

Women do not have prostates and this is a study of prostate health

Upright MRI for Prostate Cancer Screening

Feasibility and Efficacy of Upright MP - MRI for Prostate Cancer Screening

To compare performance characteristics of Upright MP-MRI versus 3T MP-MRI in detecting clinically significant PCa and PCa in general.

Claustrophobic Questionnaire (CLQ) is a 46 item instrument, each item score on a likert scale from 1-5, full scale from 36 to 180, with higher score indicating more anxiety.

NCCN Distress Thermometer is a visual scale - full scale from 0-10, higher score indicating higher level of distress

Magnetic Resonance Imaging-Anxiety Questionnaire (MRI-AQ) is a 15 item instrument, each item score on a likert scale from 1 to 4, full scale range from 15 to 66, with higher score indicating higher degree of anxiety.

To compare the diagnostic yield of using MP-MRI with thresholds PSA density used for detecting prostate cancer.

Number of correctly identified side of prostate unaffected in men with pathological disease

The Fonar Corporation

Icahn School of Medicine at Mount Sinai

Professor

Symptoms and General Pathology

Neoplastic Cells, Circulating

Neoplasm Metastasis

Neoplastic Processes

Sampling of Circulating Tumoral Cells will be done

prostate cancer diagnosis

yang gao

liang liang

This trial is a prospective, multicentre, diagnostic study. This study aims to evaluation the early diagnostic ability of circulating tumor cells plus multimodal MRI for prostate cancer.

This trial is a prospective, multicentre, diagnostic study. This study aims to evaluation the early diagnostic ability of circulating tumor cells plus multimodal MRI for prostate cancer.

We will enroll 808 men with clinical suspicion of prostate cancer due to higher level PSA（\>4ng/ml）or other examination abnormal. All the participants will receive prostate biopsy，the circulating tumor cells（CTCs）will be detected before biopsy.

This study will evaluate the diagnostic ability of CTCs+MRI and CTCs+MRI+PSA，including sensitivity, specificity, predictive values, diagnostic accuracy and receiver operating curves（ROC）.

Circulating Tumor Cells and mpMRI for Non-invasive Diagnosis of Prostate Cancer(CMNDPC)

A Prospective Multicenter Cohort Study for Non-invasive Diagnosis of Prostate Cancer: In Vivo Isolation of Circulating Tumor Cells Plus Multimodal MRI

Evaluation the diagnostic ability of CTCs counts in caner and non-cancer. All patients were confirmed by pathology.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MagneThermoPro : Magnetic Resonance Thermography of Human Prostate	NCT04822272	Prostate Cancer...	MRI thermometry	18 Years -	University Hospital, Bordeaux
MagneThermoPro : Magnetic Resonance Thermography of Human Prostate	NCT04822272	Prostate Cancer...	MRI thermometry	18 Years -	University Hospital, Bordeaux
PROVIZ - a Machine Learning Software, to Support Targeting of Prostate Biopsies on MR Images in Biopsy-naive Patients	NCT06000046	Prostate Cancer...	Automatic image...	-	Norwegian University of Science and Technology
PROVIZ - a Machine Learning Software, to Support Targeting of Prostate Biopsies on MR Images in Biopsy-naive Patients	NCT06000046	Prostate Cancer...	Automatic image...	-	Norwegian University of Science and Technology
Can Needle Size Improve Cancer Detection Rate of Transperineal MRI Target Prostate Biopsy Without Affecting Side Effects?	NCT06420115	Prostate Cancer...	different needl...	18 Years -	University Hospital Padova
PROVIZ - a Machine Learning Software, to Support Targeting of Prostate Biopsies on MR Images in Biopsy-naive Patients	NCT06000046	Prostate Cancer...	Automatic image...	-	Norwegian University of Science and Technology
MagneThermoPro : Magnetic Resonance Thermography of Human Prostate	NCT04822272	Prostate Cancer...	MRI thermometry	18 Years -	University Hospital, Bordeaux
Cognitive Fusion Prostate Biopsy With Biparametric Magnetic Resonance in the Detection of Prostate Cancer	NCT05818631	Prostate Cancer Prostate Cancer...	fusion cognitiv...	18 Years - 80 Years	Universidad Miguel Hernandez de Elche
Evaluation of Diagnostic Value of 3-T Magnetic Resonance Imaging (MRI) in Suspected Prostate Cancer	NCT01357512	Prostatic Neopl...	magnetic resona...	40 Years - 72 Years	University of Oulu
MagneThermoPro : Magnetic Resonance Thermography of Human Prostate	NCT04822272	Prostate Cancer...	MRI thermometry	18 Years -	University Hospital, Bordeaux
Upright MRI for Prostate Cancer Screening	NCT03474913	Prostate Cancer Elevated PSA Elevated Prosta...	Upright MRI Standard MRI	18 Years - 100 Years	Icahn School of Medicine at Mount Sinai
Circulating Tumor Cells and mpMRI for Non-invasive Diagnosis of Prostate Cancer(CMNDPC)	NCT05947188	Prostate Cancer	prostate cancer...	50 Years - 80 Years	First Affiliated Hospital Xi'an Jiaotong University

Spots Global Cancer Trial Database for prostate cancer diagnosis