Integration Of Fluid Integration Of Fluid And Imaging-Based Markers For Prostate Cancer

Overview

About this study

The purpose of this study is to refine the current diagnostic algorithm and improve the pre-biopsy detection of high-grade prostate cancer by 1) identifying patients with high-grade prostate cancer who may receive a negative MRI and 2) avoiding MRI and biopsy in men with benign disease and indolent prostate cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients with an elevated PSA (PSA <=15 ng/ml) and/or abnormal prostate findings

  • Patients who are biopsy-naïve or have received a prior negative biopsy or a prior biopsy positive for ASAP or low grade favorable intermediate risk cancer on active surveillance (Gleason 3+3 or 3+4)

 

Exclusion Criteria: 

  • Unable or unwilling to provide informed consent

  • Vulnerable study populations

  • PSA >15 ng/mL

  • Metastatic prostate cancer- defined as pathologic N+ on final pathology or radiographic evidence of metastatic disease on pre-procedural testing

  • No active (non-skin) malignancy within the past two years excluding low risk prostate cancer

  • Current treatment with any form of hormone, antiandrogen, or androgen deprivation therapy

  • Treated with any form of chemotherapy or pelvic radiotherapy within the last 5 years.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 06/16/2026. Questions regarding updates should be directed to the study team contact.
 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Closed for enrollment

Jacksonville, Fla.

Mayo Clinic principal investigator

Closed for enrollment

Rochester, Minn.

Mayo Clinic principal investigator

Robert Karnes, M.D.

Open for enrollment

Contact information:

Janelle Worthington

5072669560

worthington.janelle@mayo.edu

More information

Publications

Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions