Could a simple blood or urine test replace prostate biopsies?
NCT ID NCT06144619
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether non-invasive tests—like blood, urine, and genetic analysis—can help track prostate cancer progression without repeated biopsies. Researchers will follow 500 men with low, intermediate, or high-risk prostate cancer as they receive standard care. The goal is to find biomarkers that signal when the disease is getting worse, potentially reducing the need for invasive procedures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to better ways to monitor prostate cancer without repeated invasive biopsies, improving patient comfort and care decisions.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't directly improve health. It is currently suspended, and results may not change practice for years.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Prostate cancer patients who had received primary diagnosis at Moffitt or outside the cancer center with available records (radiology, pathology, access to tissue samples).
- Ages
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35 to 85 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Prostate cancer patients who had received primary diagnosis at Moffitt or outside the cancer center with available records (radiology, pathology, access to samples). * No-Surgery (Intermediate risk) group: patients diagnosed with pre-biopsy mpMRI, blood plasma: the biopsy must consist of a pathological diagnosis with a Gleason pattern score. * Surgery (High risk) group: patients who had radical prostatectomy (RP) with (or with-out) mpMR imaging, bio fluids available for research will be accrued for this group. We follow the NCCN recommendations for high-risk (Unfavorable intermediate risk or High-risk) groups inclusion and follow-up criteria (58, 89, 90). * ≥ 4 ng/ml and ≤ 20 ng/ml and PSA ≤ 10 ng/ml (for late disease), within 3 months of study enrollment. * Age 35 through 85 years. * Zubrod/ECOG performance status \<2; * Ability to understand and willingness to sign a written informed consent document. * Patients who agree to have a multiparametric MRI with targeted/template biopsy. * Patients must agree to fill out the longitudinal psychosocial questionnaires assessing health related quality of life. * Availability of Bio-samples (blood plasma, urine) for exosomal, proteomic, genomic and pathology (H\&E slides, IHC slides). * Quantity of bio-samples; Blood, Urine, tissue sections (including FFPE) for each region of interest. Exclusion Criteria: * Subject is not a candidate for multiparametric MRI with contrast. Some reasons may include (but are not limited to): renal insufficiency, foreign body or pacemakers. * No prior pelvic radiotherapy * No prior surgery to the prostate, other than transurethral procedures for benign prostatic hyperplasia (e.g., transurethral resection, green light laser treatment) * No concurrent, active malignancy, other than non-metastatic skin cancer of any type, superficial bladder cancer, or early-stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma) or \> Bilateral hip replacement.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Other studies related to the condition(s) this trial covers.
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- Can a new PET tracer spot hidden prostate cancer spread?
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- A scanner in the operating room could show surgeons exactly where prostate cancer remains