Could a urine test replace scans for tracking prostate cancer treatment?
NCT ID NCT07837063
First seen Sep 23, 2026 · Last updated Sep 24, 2026 · Updated 1 time
Summary
Researchers are investigating whether substances in urine and blood can show how well hormone therapy is working in men with metastatic prostate cancer. The study enrolls 40 men with hormone-sensitive metastatic prostate cancer or disease progression on treatment. By analyzing metabolite patterns over 12 months, the team aims to see if these markers can detect response and progression more simply than current imaging and blood tests.
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 the markers prove reliable, doctors could one day monitor prostate cancer treatment response with a simple urine test instead of repeated scans and blood draws.
- What could go wrong
- This is a small study of 40 men, and the metabolite markers may not prove accurate enough to replace standard imaging and blood tests. The findings may not apply to all prostate cancer patients.
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 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
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
Men with metastatic prostate cancer.
- Ages
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18 years and older
- 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: * \- Male 18 years of age or older * Diagnosis of metastatic adenocarcinoma of the prostate (either histologically confirmed or PSA \>100 and multiple bone metastasis and or abnormal MRI prostate compatible with metastatic prostate cancer) * Previous radical prostatectomy or radical radiotherapy is allowed * Bisphosphonate therapy (any type) is allowed but needs to be continued throughout the time on study * Bicalutamide, aLHRH (any type) or LHRH (any type) should be continued throughout the study period. * Any medication to treat medical conditions (for example hypertension) at enrolment are allowed and should be continued. These should be recorded on the CRF. * If the patient takes any complementary therapies (for example cannabis oil), potential risks and drug interactions should be discussed with the patient. If the patient decides to continue with the medication, they should be recorded on the CRF. Group 1-3: * Metastatic (M1) hormone sensitive prostate cancer (conventional or PSMA PET or MRI imaging). * Any pelvic lymph nodes (N0 - N1) and any local disease stage (T1-T4) Group 1: * Visceral (M1b) or lymph node (M1a) metastasis, up to 5 bone metastasis * Treatment decision for darolutamide by clinician Group 2 * High volume bone metastasis (\>5), other sites are allowed (M1a or 1b) * Treatment decision for darolutamide by clinician Group 3 * Any metastasis, M1a or 1b) * Treatment decision for darolutamide and docetaxel by clinician Group 4 * Metastatic disease progression on PSA, imaging, or both. * Currently on abiraterone, apalutamide, darolutamide or enzalutamide * PSA progression is defined as 3 consecutive raises above nadir and \> 2ng/ml over a period of 3 months, PSA doubling time \<12 months * Imaging can be any of the following: CT scan, NM bone scan, PSMA PET, MRI. * Prior chemotherapy for mHSPC or CRPC is acceptable, but not mandatory * Any treatment decision by clinician according to patient fitness, wishes and previous treatment according to standard of care protocols for CRCP is allowed. Exclusion Criteria: * \- Non-metastatic prostate cancer (i.e. patients with only prostate and regional lymph node involvement are not eligible). * Patients who have been \>3 months on ADT (aLHRH (any type) or LHRH (any type) ) at screening are not eligible * Group 1-3 already commenced abiraterone, apalutamide, darolutamide or enzalutamide * Group 1-3 already commenced docetaxel for mHSPC
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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
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, Merseyside, L7 8YA, United Kingdom
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