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

Low-resolution transrectal ultrasound guided prostate biopsy (standard of care)

Ultra-high resolution transrectal ultrasound guided prostate biopsy

Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system

High-resolution ultrasound guided prostate biopsy

Ultrasound guided prostate biopsy using standard of care ultrasound system

Standard ultrasound guided prostate biopsy

This trial uses a ultra high-resolution ultrasound system and specialized transducer, intended for use in prostate imaging. The system's image resolution is significantly better than the standard of care, due to its higher frequency. This allows the system to visualize suspicious areas and structures, and for greater accuracy for guided biopsy.

The primary objective of this study is to demonstrate that ultra high-resolution transrectal ultrasound (UHR-TRUS) is superior to conventional low-resolution transrectal ultrasound (LR-TRUS) in detecting clinically significant cancer among men without known prostate cancer and with an indication for prostate biopsy.

The secondary objective of this study is to compare the difference in the rate of detection of clinically significant cancer between LR-TRUS and UHR-TRUS, from before investigator training to after investigator training.

The tertiary objective for the investigation is to compare the combined sensitivity and specificity in determining cancer detection overall for image-guided biopsy in UHR-TRUS vs. LR-TRUS.

This is a two-arm multi-centre randomized trial of LR-TRUS versus UHR-TRUS for guided prostate biopsies in men with no known history of prostate cancer. This trial will enroll a minimum of 800 and a maximum of 2000 patients with regular interim analyses to determine the trial's final sample size. These numbers are based on predictive probabilities of trial success.

The investigation is designed as a comparative non-blinded analysis of LR-TRUS vs. UHR-TRUS. Participants will be randomized to either high-resolution or low resolution ultrasound with an equal chance of being in either group. The randomization scheme will be stratified by centre.

When a subject arrives at the institution for his biopsy, the Study Coordinator opens a sealed envelope that indicates to the study participant and physician whether the procedure will be performed using LR-TRUS or UHR-TRUS.

All subjects have an indication for prostate biopsy, and thus, inclusion of a non-treatment group would necessitate a group of men not to receive standard of care. As such, there is no control group in the subject population.

Procedures in the study are:

* obtaining informed consent for the subject
* collecting pre-biopsy information and recording it on the case report form (CRF)
* perform biopsy procedure
* record biopsy details in CRF
* prepare biopsy specimens for pathology

Data from CRFs will be stored in a proprietary database that is accessed by a web-based interface, where access is limited to those with login and password. No subject-identifiable information will be entered in the database.

The primary endpoint is the detection of clinically significant prostate cancer, i.e., the number of men with clinically significant prostate cancer determined by pathology review among all men randomized and biopsied. Pathological analysis on 12-core biopsy samples will be the only mechanism used to determine if study subjects have prostate cancer.

Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer

Pathology analysis of prostate biopsy is reviewed for indication of clinically significant prostate cancer. Interim analyses are planned beginning when 800 patients have been enrolled and after every additional 200 patients are enrolled up to the maximum sample size of 2000 patients.

Comparison of pre- and post-training percentage of participants found to harbor clinically significant prostate cancer within the UHR-TRUS arm of the trial

Pathology analysis of prostate biopsy is reviewed. Sensitivity of targeted biopsy for each arm will be calculated as the number of targeted biopsy that also found cancer among all targeted biopsies. Specificity of targeted biopsy for each arm will be calculated as the number of non-targeted biopsies that find no cancer among all non-targeted biopsies. Interim analyses are planned beginning when 800 patients have been enrolled and after every additional 200 patients are enrolled up to the maximum sample size of 2000 patients.

Exact Imaging

Low-resolution transrectal ultrasound guided prostate biopsy (standard of care)

Standard ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using standard of care ultrasound system

LR-TRUS

Ultra-high resolution transrectal ultrasound guided prostate biopsy

High-resolution ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system

UHR-TRUS

Total

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Canada

United States

Region of Enrollment

Manager, Clinical Research

Intent to Treat

Per Protocol

Intent To Treat includes all subjects, Per Protocol includes only subjects without protocol deviations.

Percentage of Participants With Clinically Significant Prostate Cancer

Pre-Training

Post-Training

Pre and post-training detection rate for csPCa for the UHR-TRUS arm only (as investigators received additional training on this imaging modality)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer	NCT02079025	Prostatic Neopl... Prostate Cancer Cancer of the P...	High-resolution... Standard ultras...	40 Years - 79 Years	Exact Imaging
Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer	NCT02079025	Prostatic Neopl... Prostate Cancer Cancer of the P...	High-resolution... Standard ultras...	40 Years - 79 Years	Exact Imaging

Spots Global Cancer Trial Database for standard ultrasound guided prostate biopsy