Active not recruitingOBSERVATIONAL

Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically-significant Prostate Cancer

This research is investigating a new blood test called ClarityDX Prostate. The main goal is to find out how accurate this test is at predicting whether prostate cancer found during a biopsy is serious enough to need treatment. Researchers are studying men who have a PSA blood test result of 3 ng/mL or higher, or other reasons for concern, and are already scheduled to have a prostate biopsy. They want to see if the ClarityDX Prostate test can help doctors make more informed decisions about who truly needs further prostate cancer investigation, potentially reducing unnecessary biopsies or finding serious cancers earlier. This study could help improve how prostate cancer is diagnosed.

At a glance

Status

Active not recruiting

Sponsor

Nanostics

Enrolment target

2,800

Start

06 Jun 2019

Estimated completion

01 Mar 2027

Prostate Cancer

What is this study about?

Imagine you've had a blood test and your PSA (Prostate Specific Antigen) level is a bit higher than normal. Sometimes, this can suggest there might be a problem with your prostate, like prostate cancer. To find out for sure, doctors often recommend a prostate biopsy, which involves taking small samples of the prostate for examination.

This study is looking at a new blood test called ClarityDX Prostate. The idea is to use this new blood test to help doctors better understand the results of your PSA test. It's like having an extra piece of information that can make the picture clearer before considering a biopsy. The researchers want to see if this new blood test can accurately predict if any prostate cancer found is likely to be serious and need treatment, or if it might be a less harmful type that can be monitored.

The main aim is to make sure men who really need treatment for prostate cancer are identified, while also potentially helping to avoid unnecessary biopsies for those who don't have serious cancer. By making the diagnosis process more accurate, doctors hope to give men clearer information and more tailored care decisions about their prostate health.

Key takeaways

This study is testing a new blood test called ClarityDX Prostate.
It aims to improve how serious prostate cancer is detected.
It's for men having a prostate biopsy due to raised PSA or prostate concerns.
Taking part means helping future prostate cancer diagnosis.
Your medical care won't change if you join.
There are minimal risks as it uses existing samples.

Who may be eligible?

You might be able to take part in this study if you are a man between 40 and 75 years old. You should not have been diagnosed with prostate cancer before, and you must be scheduled to have a prostate biopsy because you have a PSA blood test result of 3 ng/mL or higher, or your doctor suspects prostate cancer for other reasons.

It's important that you are willing to give your permission for health information to be shared for the study. You also need to be having your biopsy in one of the areas where the study is taking place. If you are under 40 or over 75, have previously had cancer (other than some skin cancers), or are not having a prostate biopsy, you won't be able to join this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man aged between 40 and 75 years old?
Have you never been diagnosed with prostate cancer before?
Are you scheduled to have a prostate biopsy?
Is your PSA blood test result 3 ng/mL or higher (within the last 6 months)?
Are you willing for your health information to be used for this study?
Is your biopsy taking place in an area where this study is recruiting?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your involvement will be quite straightforward. The study will mainly use information from your planned prostate biopsy and your blood test results. You won't need to take any new medication or have extra appointments just for the study itself.

The researchers will collect a blood sample from you at the same time as your routine blood tests for your biopsy, and they will use this to perform the ClarityDX Prostate test. They will then compare the results of this new test with the results from your prostate biopsy. Your participation will last until your biopsy results are known and analysed as part of the study.

Potential risks and benefits

Taking part in this study means you could be helping to improve how prostate cancer is diagnosed in the future, potentially leading to more accurate decisions for other men. There are very few direct risks to you as this study uses samples collected during your routine medical care; it doesn't involve extra procedures. You should know that you can choose to leave the study at any time, for any reason, and this decision will not affect your medical care.

Locations (3)

Johns Hopkins University
Verified postcode
Baltimore, United States
Prostate Cancer Centre
Verified postcode
Calgary, Canada
Kipnes Urology Centre
Verified postcode
Edmonton, Canada

Common questions

What is PSA?

PSA stands for Prostate Specific Antigen. It's a protein made by the prostate gland. A blood test measures its level, and high levels can sometimes suggest prostate problems, including cancer.

What is a prostate biopsy?

A prostate biopsy is a procedure where several tiny tissue samples are taken from the prostate gland. These samples are then looked at under a microscope to check for cancer cells.

Will this study change my medical care?

No, taking part in this study will not change the medical care you receive for your prostate. The ClarityDX Prostate test is being evaluated, and its results will not directly guide your treatment decisions in this study.

Do I have to do anything special?

No, you just need to agree to let the researchers use a blood sample collected during your normal care and your biopsy results. There are no extra tests or visits for you.

What is "clinically-significant" prostate cancer?

This refers to prostate cancer that is more serious and likely to grow quickly or spread, meaning it would typically need active treatment rather than just being monitored.