Neoplasms

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Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

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Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Recent guidelines now recommend multi parametric magnetic resonance imaging prior to biopsy for all men as an integral part of improved diagnosis of clinical significant prostate cancer. However, magnetic resonance imaging targeted biopsy is a strategy that focuses on maximizing detection of clinical significant prostate cancer, but this procedure has the disadvantage of leading to higher detection of clinically insignificant prostate cancers. One of the risk-stratifications developed to minimize the existing disadvantages and avoid unnecessary biopsy procedures is a strategy in which multi parametric magnetic resonance imaging and prostate-specific antigen density are used in combination. This is especially important in all patients with PI-RADS (Prostate Imaging Reporting and Data System) 3 lesions which are also interpreted as indeterminate mpMRI findings. Current guidelines suggest that biopsy may be omitted in some patient groups with PI-RADS 3 lesions in the risk-adapted strategy involving prostate-specific antigen density. The aim of this study was to evaluate the role of risk-adapted strategies involving prostate-specific antigen density in biopsy decision to avoid unnecessary biopsy vs the risk of missing clinical significant prostate cancer diagnosis in patients with PI-RADS 3 lesions.

Because prostate cancer is a male-specific disease

Risk-adapted Strategy Including Magnetic Resonance Imaging and Prostate-specific Antigen Density in Blood for Biopsy Decision in Patients With Lesions Suspicious for Prostate Cancer

Risk-adapted Strategy Combining Magnetic Resonance Imaging and Prostate-specific Antigen Density to Individualize Biopsy Decision in Patients With PI-RADS 3 'Gray Zone' Lesions

Ankara Etlik City Hospital

M.D.

Symptoms and General Pathology

Body Weight

Subjects will lie in supine position. The systematic use of a headset will reduce the acoustic noise inherent to the machine. We are going to carry out the standard MR prostate protocol which patients usually benefit from in clinical routine. This protocol consists of morphological sequences (T2 weighting with spin echo readout), Diffusion MR and dynamic contrast-enhanced sequences. We will then perform an additional faster enhanced T2-weighting SE and DWI sequences combined with Deep Learning reconstruction

MR prostate exam

MR prostate exam is essential for the diagnosis, workup and follow-up of prostate cancer. It allows to detect subclinical prostate cancer following an increase in the level of PSA. The investigators can score the lesion according to the PIRADS classification and obtain an estimate of lesion malignancy. To perform this classification, T2 and DWI sequences are essential.

Detection and characterization of malignant lesion is important to address appropriate patient care pathway. The purpose of this project is to evaluate novel deep learning (DL) T2-weighted TSE (T2DL) and Diffusion (DWIDL) sequences for prostate MR exam and investigate its impact on diagnostic, examination time, image quality, and PI-RADS classification compared to standard T2-weighted TSE (T2S) and standard Diffusion (DWIS) sequences.

Evaluation of Rapid T2-weighted and DWI MR Sequences Reconstructed by Deep Learning for Prostate Imaging

Advanced DL-based T2w and DWI MR Sequences for Prostate Imaging

Centre Hospitalier Universitaire, Amiens

Single Arm Study, MRI and Prostate-Biopsy on same patient, individual patient acts as own control for intervention

First an advanced MRI prostate image is obtained, annotated and recorded by the Radiology of the Kantonsspital Winterthur. Next, using special fusion technology, the recorded MRI image is fused with a live transrectal ultrasound by the Urologist who performs a MRI/TRUS fusion biopsy.

MRI-TRUS fusion prostate biopsy

The investigators examined whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, the investigator inspected whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, the investigators study aimed to determine the sensitivity and specificity of mpMRI with respect to prostate carcinoma detection.

Purpose: In recent years, multiparametric Magnet Resonance Imaging (mpMRI) has been established as a diagnostic imaging technique of the prostate and its assessment standardized with the "prostate imaging - data and reporting system" (PI-RADS v2). The previously established Likert scale from 1 to 5 has been shown to reflect the increasing probability of a carcinoma. Suspicious MRI lesions can be biopsied in a targeted fashion using ultrasound navigation termed fusion biopsy. The investigators examined whether a high PI-RADS v2 score correlates with the presence of prostate cancer. In addition, the investigators inspected whether the lesion size as determined by mpMRI correlates with the presence of prostate cancer. Furthermore, the investigators study aimed to determine the sensitivity and specificity of mpMRI with respect to prostate carcinoma detection.

Materials and Methods: This prospective study includes 228 consecutive patients, which underwent a perineal MRI-TRUS-fused prostate biopsy (BiopSee®, MedCom Company) during the period of September 2015 to March 2017 at the cantonal hospital Winterthur due to a suspicious PSA value, a suspicious digital rectal examination or a known prostate cancer under active surveillance. 71 patients were excluded due to lack of PI-RADS v2 diagnosis and / or MRI performed at a different center. Targeted biopsies were performed specifically in the indicated MRI lesions and standardized over the rest of the prostate (system biopsy).

Accuracy of mpMRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in Detection of Prostate Cancer

Accuracy of Multi-parametric Prostate MRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in the Detection of Prostate Cancer:

Histological grade of the glandular structures of prostate cancer tissue or the difference in appearance compared with a normal structure.

Pattern 1 - corresponds to a well differentiated carcinoma. Pattern 2 - corresponds to a moderately differentiated carcinoma. Pattern 3 - invade the surrounding tissue or having an infiltrative pattern; corresponds to a moderately differentiated carcinoma.

Pattern 4 - corresponds to a poorly differentiated carcinoma. Pattern 5 - corresponds to an anaplastic carcinoma.

The pathologist then sums the pattern-number of the primary and secondary grades to obtain the final Gleason score.

Gleason scores range from 2 to 10, with 2 representing the most well-differentiated tumors and 10 the least-differentiated tumors.

New grading system for histological grade of the glandular structures of prostate cancer tissue or the difference in appearance compared with a normal structure

Grade Group 1 (Gleason score ≤6) - Only individual discrete well-formed glands Grade Group 2 (Gleason score 3+4=7) - Predominantly well-formed glands with a lesser component of poorly-formed/fused/cribriform glands Grade Group 3 (Gleason score 4+3=7) - Predominantly poorly-formed/fused/cribriform glands with a lesser component of well-formed glands Grade Group 4 (Gleason score 8)

* Only poorly-formed/fused/cribriform glands or
* Predominantly well-formed glands with a lesser component lacking glands or
* Predominantly lacking glands with a lesser component of well-formed glands Grade Group 5 (Gleason scores 9-10) - Lacks gland formation (or with necrosis) with or without poorly-formed/fused/cribriform glands

millilitre; size of suspected areas in prostate gland in MRI

Radiological grading system of prostate lesions in mpMRI

The PI-RADS v2 system is designed to standardize image acquisition and reporting, and to be used by medical professionals in the initial evaluation of patients to assess the risk of clinically significant prostate cancer that may require biopsy and treatment.

The scale is based on a score "Yes" or "No" for Dynamic Contrast-Enhanced (DCE) parameter, and from 1 to 5 for T2-weighted (T2W) and Diffusion-weighted imaging (DWI). The score is given for each lesion, with 1 being most probably benign and 5 being highly suspicious of malignancy:

PI-RADS 1: very low (clinically significant cancer is highly unlikely to be present) PI-RADS 2: low (clinically significant cancer is unlikely to be present) PI-RADS 3: intermediate (clinically significant cancer is equivocal) PI-RADS 4: high (clinically significant cancer is likely to be present) PI-RADS 5: very high (clinically significant cancer is highly likely to be present)

ng per ml; enzyme secreted by the prostate gland

ng per ml per ml; The relationship of the prostate specific antigen level to the size and weight (volume) of the prostate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Risk-adapted Strategy Including Magnetic Resonance Imaging and Prostate-specific Antigen Density in Blood for Biopsy Decision in Patients With Lesions Suspicious for Prostate Cancer	NCT06029088	Prostate Cancer Prostate Adenoc...		45 Years - 75 Years	Ankara Etlik City Hospital
Evaluation of Rapid T2-weighted and DWI MR Sequences Reconstructed by Deep Learning for Prostate Imaging	NCT06094322	Prostate Cancer	MR prostate exa...	18 Years -	Centre Hospitalier Universitaire, Amiens
Evaluation of Rapid T2-weighted and DWI MR Sequences Reconstructed by Deep Learning for Prostate Imaging	NCT06094322	Prostate Cancer	MR prostate exa...	18 Years -	Centre Hospitalier Universitaire, Amiens
Evaluation of Rapid T2-weighted and DWI MR Sequences Reconstructed by Deep Learning for Prostate Imaging	NCT06094322	Prostate Cancer	MR prostate exa...	18 Years -	Centre Hospitalier Universitaire, Amiens
Accuracy of mpMRI and MRI-targeted, Ultrasound-navigated Prostate Fusion Biopsy in Detection of Prostate Cancer	NCT03615131	Prostate Cancer	MRI-TRUS fusion...	18 Years -	Kantonsspital Winterthur KSW

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Spots Global Cancer Trial Database for pirads

Every month we try and update this database with for pirads 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.

Every month we try and update this database with for pirads 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.