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

conventional/systematic biopsy, targeted fusion biopsy and cognitive biopsy

Targeted biopsy

This is a pilot study to determine cancer detection rate of conventional/systematic versus targeted biopsy methods in diagnosis of potentially lethal prostate cancer. This is a diagnostic trial using each patient as his own control.

Each biopsy session would be preceded by mpMRI, which would be delineated and assigned a degree of suspicion by a radiologist (see above).The PI-RADS scoring system will be used to assign a degree of suspicion to regions of interest within the prostate. A second reader will independently score the RSI on a Likert scale, blinded to the other MRI data. The regions of interest will be delineated using software developed by Eigen in collaboration with a study co-author (D.M.), now commercially available and in use by the UCLA team for the past 2 years (ProFuse, Eigen).The RSI data will be integrated with the standard mpMRI data and any change in scoring or presence of additional lesions, determined by RSI, will be quantified. For men with a MR-visible target of PI-RADS score 3 or more, irrespective of RSI score, the biopsy session would then proceed in an ordered routine, as follows:

1. Conventional ultrasound-guided 12-core systematic biopsy would be performed first. This portion will be performed without operator knowledge of the MRI report, i.e., the urologist will be blinded to possible tumor location and use the method in standard practice throughout the U.S. for many years.
2. Next a targeted biopsy would be performed using visual guidance (cognitive fusion), under the supervision of a radiologist specializing in prostate MRI. The radiologist will be in the biopsy suite and help the urologist direct needle at location of region of interest in the prostate seen on MRI. Three directed biopsy cores will be obtained.
3. Third, a targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. The prostate will be scanned and the MRI region of interest (target) brought into the 3D model via device fusion. Targeted biopsy will be performed by taking three cores of tissue from the target area, visualized as a 3D region in the fusion device.

Biopsy sites to be dictated by geometric guides (12 point pattern vs visual direction of radiologist vs fusion target), not chosen arbitrarily.

The above biopsy schema will not require any more procedure time or samples taken than fusion biopsy as performed under IRB approval at our institution for the last five years. Additional cores will be required for the visual biopsy method, but no biopsy cores will be obtained from secondary targets. Most patients exhibit secondary targets. An analysis of data from past 2 years demonstrated that the chance of a secondary target showing significant cancer, not present in a primary target, is less than 1%. Therefore, secondary targets will not be sampled, as cores are instead taken from primary targets using the two methods. In 200 men undergoing initial biopsy, an average of 17 +/- 3 S.D. cores/patient has been obtained. In the present proposal, 18 cores will be taken. Thus, the number of cores/patient in this trial will not substantially exceed the number that has been routinely taken in our practice in the past.

A sampling method of three directed cores per target was chosen as a compromise between what is clinically feasible and a statistical ideal of taking additional cores for significant cancer detection in lower grade targets.

The cognitive biopsy will require approximately 90 seconds of additional time, but this added time will be more than compensated by the reduced time obtained from excluding secondary targets. The overall biopsy schema should require no more (and probably less) than the 15-20 minutes/procedure as in the past. Biopsies will be performed by an experienced team, which has been working together since 2009.

Prospective Assessment of Image Registration for the Diagnosis of Prostate Cancer

Paired CAP: Prospective Assessment of Image Registration for the Diagnosis of Prostate Cancer

Patient participation is only confined to the biopsy visit.

National Cancer Institute (NCI)

Jonsson Comprehensive Cancer Center

Adenocarcinoma

Patients with suspected prostate cancer consequently underwent TRUS-guided, cognitive, fusion and transperineal template mapping biopsy

TRUS-guided biopsy - extensive number of biopsies taken transrectally involving peripheral and transitional zones (8-12 cores); cognitive biopsy - targeted biopsy with MRI information and TRUS guidance but without fusion technology (2-4 cores); fusion biopsy - targeted biopsy with MRI information using MRI/TRUS fusion technology (2-4 core); transperineal template mapping biopsy - systematic transperineal TRUS-guided biopsy with special template use to aid accurate placement of biopsy needles (more than 20 cores).

consequently performed 4 biopsy methods (TRUS-guided biopsy, cognitive, fusion and transperineal template mapping biopsy)

The aim of this study is to compare clinically significant prostate cancer detection rate by the 4 biopsy methods: TRUS-guided, cognitive, fusion and transperineal template mapping biopsy.

It is recommended to combine MRI-guided biopsy with systematic (TRUS-guided or transperineal template mapping biopsy) biopsy for high yield of prostate cancer diagnosis. Nevertheless, it remains unclear which biopsy combination is more precise for prostate cancer detection.

Taking into consideration the variety of prostate biopsy methods (TRUS-guided, cognitive, fusion and transperineal template mapping biopsy), the issue of indications for each of them remains unresolved. Current EAU guidelines recommend combining MRI-guided biopsy with systematic (TRUS-guided or transperineal template mapping biopsy) one for high yield of prostate cancer diagnosis. Nevertheless, it also remains unclear which biopsy combination is more precise for prostate cancer detection.

This is a prospective single-arm study.

All patients underwent prostate TRUS examination and mpMRI. Suspicious lesion found on MRI were classified with the Pi-RADS v2.1. First step: the "unblinded" urologist №1 performed a fusion and transperineal template mapping biopsy. Second step: the "blinded" urologist №2 performed TRUS-guided and cognitive biopsy.

Objectives of the study: to determine clinically significant prostate cancer detection rate, overall cancer detection rate, clinically insignificant prostate cancer detection rate, sampling efficiency (positive biopsy cores' number, maximum cancer core length (MCCL)). Results were calculated for each biopsy method separately and for combinations of TRUS-guided and cognitive biopsy (combination №1) and fusion and transperineal template mapping biopsy (combination №2).

First step: the "unblinded" urologist №1 performed a fusion and transpeineal template mapping biopsy. Second step: the "blinded" urologist №2 performed TRUS-guided and cognitive biopsy. All specimens were obtained within a single procedure.

The "blinded" urologist performed TRUS-guided and cognitive biopsy without prior knowledge about MRI results

Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection

Ratio of patients with preoperative Pi-RADS ≥3 with defined clinically significant prostate cancer (ISUP ≥2) in relation to total number of patients

Ratio of patients with preoperative Pi-RADS ≥3 with defined prostate cancer in relation to total number of patients

Ratio of patients with preoperative Pi-RADS ≥3 with defined clinically insignificant prostate cancer (ISUP 1) in relation to total number of patients

Ratio of cores with detected prostate cancer in relation to overall numbers of cores

Median length of core with prostate cancer in realtion to whole biopsy core

Ratio of patients with preoperative Pi-RADS ≥3 with downgraded ISUP score in relation to maximum ISUP score obtained among biopsies

Ratio of patients with preoperative Pi-RADS ≥3 with upgraded ISUP score in relation to maximum ISUP score obtained among biopsies

Prognostic factors of clinically significant and overall prostate cancer detection rate

Gleason score obtained within biopsy and the post-prostatectomy pathology

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Assessment of Image Registration for the Diagnosis of Prostate Cancer	NCT02425228	Elevated PSA Prostate Cancer	Targeted biopsy	-	Jonsson Comprehensive Cancer Center
Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection	NCT05589558	Prostate Cancer Prostate Adenoc...	consequently pe...	18 Years -	I.M. Sechenov First Moscow State Medical University
Prospective Comparison of the Four Biopsy Methods for Prostate Cancer Detection	NCT05589558	Prostate Cancer Prostate Adenoc...	consequently pe...	18 Years -	I.M. Sechenov First Moscow State Medical University
Prospective Assessment of Image Registration for the Diagnosis of Prostate Cancer	NCT02425228	Elevated PSA Prostate Cancer	Targeted biopsy	-	Jonsson Comprehensive Cancer Center

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