Marker Driven Selection of Patients for Prostate Biopsy and Management (NCT04240327) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Marker Driven Selection of Patients for Prostate Biopsy and Management
United States289 participantsStarted 2020-06-29
Plain-language 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 and urine biomarkers is more effective at detecting prostate cancer than standard of care interpretation of mpMRI with the Prostate Imaging Reporting and Data System (PIRADS).
Who can participate
Age range
40 Years – 85 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Negative Predictive Value (NPV) for ruling out GG2+ prostate cancer via Habitat Risk Score (HRS) MRI Interpretation software combined with a panel of blood and urine biomarkers, versus via standard of care (SoC) MRI interpretation with PIRADS v2.
. 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.