Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Prostate-specific antigen (PSA) and digital rectal exam (DRE) are standard of care for monitoring patients on active surveillance or at risk of having low-risk prostate cancer. A novel virtual biopsy (VB) monitoring protocol will be implemented:

1. PSA bi-annually or more often according to the discretion of the urologist.
2. Annual DRE.
3. Visit with the urologist bi-annually.
4. Multi-parametric MRI (mpMRI) every year for 3 years.
5. Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year.

1. PSA bi-annually or more often according to the discretion of the urologist.
2. Annual DRE.
3. Visit with the urologist bi-annually.
4. Multi-parametric MRI (mpMRI) every year for 3 years.
5. Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year.

virtual biopsy (VB) monitoring protocol

Lee Ponsky

The purpose of this study is to examine the use of MRI surveillance for patients with no prostate cancer, potential prostate cancer, or diagnosed low-grade prostate cancer.

This study will use MRI instead of prostate biopsy in combination with regularly scheduled urologist visits, interval PSA checks, and annual DRE to help establish a non-invasive method for 1) participants with a negative prostate MRI (PI-RADS 1 or 2) who have never had a biopsy; 2) participants with a positive MRI (PI-RADS score of 3, 4, or 5) and negative MRI-targeted biopsy pathology; and 3) monitoring participants with clinically diagnosed low risk prostate cancer who are on active surveillance. However, if at any point, clinical suspicion indicated either by the presence of suspicious lesions on the MRI, rising PSA, and/or positive DRE arises, then an immediate biopsy will be performed.

Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and at Risk of Prostate Cancer

Evaluation of a Novel, Non-Invasive Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and Patients at Risk of Harboring Low-Risk Prostate Cancer: A Prospective Non-Randomized Clinical Trial

Individual participant data that underlie the results reported in the published article, after deidentification (text, tables, figures).

Negative predictive value (NPV) of MRI (adjusted to the prostate VB protocol criteria). This metric will determine if the the VB protocol is statistically equal to (or greater than) the negative predictive value of the standard of care TRUS prostate biopsy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and at Risk of Prostate Cancer	NCT03823001	Prostate Cancer	virtual biopsy ...	-	Case Comprehensive Cancer Center
Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and at Risk of Prostate Cancer	NCT03823001	Prostate Cancer	virtual biopsy ...	-	Case Comprehensive Cancer Center
Virtual Prostate Biopsy Protocol for Patients on Active Surveillance and at Risk of Prostate Cancer	NCT03823001	Prostate Cancer	virtual biopsy ...	-	Case Comprehensive Cancer Center

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