Can adding chemotherapy to hormone therapy extend lives in advanced prostate cancer?
NCT ID NCT06446401
First seen Oct 14, 2026 · Last updated Oct 15, 2026 · Updated 1 time
Summary
Researchers are comparing two treatment approaches for men with high-volume metastatic hormone-sensitive prostate cancer. One approach combines androgen deprivation therapy (ADT), a novel hormone therapy, and docetaxel chemotherapy (triple therapy). The other combines ADT and a novel hormone therapy alone (double therapy). The study tracks survival, side effects, quality of life, and cost-effectiveness over five years to see which approach works better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- docetaxel added to androgen deprivation therapy and a novel hormone therapy (abiraterone, apalutamide, enzalutamide, or darolutamide)
- What this could lead to
- If triple therapy works better, it could become a standard option for men with high-volume metastatic prostate cancer, potentially extending survival and improving quality of life.
- What could go wrong
- This observational study cannot prove cause and effect, and the extra chemotherapy may add side effects like neuropathy and fatigue. Results may not apply to all patients.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 1,400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2031
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
Patients with mHSPC and high tumor burden initiating treatment with triple or double therapy.
- 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: Patients eligible for inclusion in this study must meet all of the following criteria: * Patients should have initiated triple or double therapy no longer than 3 months from the start of ADT, * Patients must have mHSPC at the time of enrolment, and high metastatic burden. * Patients must be ≥ 18 years old at the time of enrolment. Note: NHT could be abiraterone acetate, apalutamide, darolutamide or enzalutamide. Exclusion Criteria: Participants meeting any of the of the following criteria are not eligible for inclusion: * Patients who do not understand written and/or oral instructions in Swedish.
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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
2 sites. 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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Uppsala University
RECRUITINGUppsala, Uppsala County, 753 10, Sweden
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Uppsala University Hospital
NOT_YET_RECRUITINGUppsala, Region Uppsala, 751 85, Sweden
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Other studies related to the condition(s) this trial covers.
- Comparison of multiparametric magnetic resonance imaging (mpMRI) versus Prostate-Specific membrane antigen positron emission tomography (PSMA-PET) for the evaluation of prostate imaging reporting and data system (PI-RADS) ≥4 lesions in the prostate transition zone: a prospective clinical study
- The investigation of new biological markers for prostate cancer diagnosis and management in chinese population
- BActinium-2: a phase 1b, 2 part, multicenter, open label study to evaluate the safety and efficacy of intravenous administration of a B7-H3 radiopharmaceutical ([225Ac]Ac AKY 2519) in participants with B7-H3 imaging positive solid tumors
- Prospective study of the effect of androgen deprivation therapy (ADT) in male patients suffered prostate cancer in asian population
- A comprehensive assessment of the physical and biological effects of patients with prostate cancer in hong kong
- A study to evaluate patient and physician benefit/ risk preferences for treatment of metastatic prostate cancer (mPC) in hong kong: a discrete choice experiment