Marker Driven Selection of Patients for Prostate Biopsy and Management

STATUS

Recruiting
End date

Jun 1, 2025
participants needed

300
sponsor

University of Miami

Send

Updated on 19 February 2024

See if I qualify

testosterone

prostate specific antigen

tumor markers

digital rectal examination

digital rectal exam

biopsy of prostate

multiparametric magnetic resonance imaging

Summary

The purpose of this research study is to determine if the interpretation of multiparametric MRI (mpMRI) with an algorithm called habitat risk score (HRS) in combination with a panel of blood biomarkers is more effective at detecting prostate cancer than standard of care interpretation of mpMRI with the Prostate Imaging Reporting and Data System (PIRADS).

Details

Condition	Malignant neoplasm of prostate, PROSTATE SPECIFIC ANTIGEN, Prostatic disorder, Elevated PSA
Age	40years - 85years
Clinical Study Identifier	NCT04240327
Sponsor	University of Miami
Last Modified on	19 February 2024

How understandable was the trial content above?

Hard to understand

Easy to understand

Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Male participant, aged 40-85 years
	In good general health as evidenced by medical history
	Referred for a biopsy of the prostate for evaluation of prostate cancer due to elevated or increasing prostate-specific antigen (PSA) or an abnormal digital rectal exam (DRE)
	Participant must agree to forego testosterone supplementation during the duration of the study due to unknown impacts on prostate cancer biomarkers
Exclusion Criteria
	Previous or current history of prostate cancer or treatment for prostate cancer
	Previous history of pelvic radiation
	Known allergic reactions to MRI contrast or inability to undergo MRI due to renal toxicity
	Inability to undergo blood draw or biopsy of the prostate as per protocol
	Prior MRI guided biopsy of the prostate for prostate cancer evaluation
	Previous prostate biopsy or prostate procedure within 6 months of enrollment within the trial
	Standard contraindications to MRI, such as allergies to contrast die, renal toxicity, ferromagnetic metal in body/eye, pacemaker, defibrillator, other mechanical device, or extreme claustrophobia (medication with anti-anxiety agents, such as Ativan, may be attempted) will prevent eligibility and will be applied for all protocol-related MRIs
	Patients with impaired decision-making capacity

How to participate?

Step 1 Connect with a study center

Select a site
Send a message

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Primary Contact

I am at least 18 years old.

By sending a message, I agree to share my information with the study team for the selected site and consent to receive emails and text messages for trial updates, notifications, and related communication. TrialX values your privacy; your information will be handled in accordance with our Privacy Policy

Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

testosterone

prostate specific antigen

tumor markers

digital rectal examination

digital rectal exam

biopsy of prostate

multiparametric magnetic resonance imaging

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Study Definition

Wikipedia

Marker Driven Selection of Patients for Prostate Biopsy and Management