Real-World data sought on triple therapy for Low-Volume prostate cancer
NCT ID NCT06661122
First seen Jun 24, 2026 · Last updated Aug 27, 2026 · Updated 5 times
Summary
This observational study will follow 100 Japanese men with low-volume metastatic hormone-sensitive prostate cancer who are receiving darolutamide plus standard hormone therapy and chemotherapy. Researchers will collect medical records to see how many men achieve very low PSA levels after one year and track any side effects. The goal is to gather real-world safety and effectiveness data to guide treatment choices.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Darolutamide (a drug that blocks androgen signals) combined with androgen deprivation therapy (ADT, a hormone therapy) and docetaxel (a chemotherapy drug)
- What this could lead to
- If successful, this study could provide real-world evidence on how well this approved combination works and is tolerated in low-volume mHSPC, helping doctors make better treatment decisions.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be influenced by patient selection and routine care variations. It is also limited to Japanese men, so findings may not apply to other populations.
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 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Male patients over the age of 18 years with a diagnosis of low-volume metastasis HSPC whom the decision for treatment with darolutamide in combination with docetaxel and ADT has been made by the physician or a delegate.
- 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: * Histologically or cytologically confirmed adenocarcinoma of prostate. * Patients have low-volume of metastatic disease documented by either by a positive bone scan, or for soft tissue either by contrast-enhanced abdominal/pelvic/chest computed tomography (CT) or magnetic resonance imaging (MRI) scan assessed by investigator. Low-volume metastasis criteria is defined as "not" meeting the high-volume criteria of the CHAARTED trial; high-volume meet the presence of visceral metastases, or four or more bone lesions including at least one outside the vertebral column or pelvis. * Documented diagnosis of mHSPC. * Patients on triplet regimen previously decided by the investigator irrespective of enrollment in the study. * Start ADT within 6 months before or at the index date. * Signed informed consent: If an eligible patient is deceased at the time of study initiation, informed consent from the legally representative(s) of the patient is required. Opt-out consent is acceptable in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects only when it is difficult to obtain signed informed consent from the patient or their legal representative. Exclusion Criteria: * Patients treated with docetaxel before darolutamide start. * Participation in an investigational program with interventions outside of routine clinical practice. * Contra-indications to darolutamide, docetaxel and ADT according to the local marketing authorization. * Participation in the PASS of darolutamide in patients with mHSPC (DADOX \[NCT06010914\]).
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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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Many locations
RECRUITINGMultiple Locations, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new chemo schedule tame side effects in prostate cancer?
- New drug combo aims to stall advanced prostate cancer
- Precision radiation may boost hormone therapy for advanced prostate cancer
- Targeted radiation plus hormone therapy may slow Low-Volume prostate cancer spread
- New study aims to cut hormone therapy side effects in prostate cancer