Could a urine test replace scans for tracking prostate cancer treatment?

NCT ID NCT07837063

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Male participants only

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, Merseyside, L7 8YA, United Kingdom

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