Can adding chemotherapy to hormone therapy extend lives in advanced prostate cancer?

NCT ID NCT06446401

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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 1,400 people

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

Started

Oct 2024

Expected to finish

Dec 2031

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

Patients with mHSPC and high tumor burden initiating treatment with triple or double therapy.

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: 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.

  1. The places running it

    2 sites. 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

    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

  • Uppsala University

    RECRUITING

    Uppsala, Uppsala County, 753 10, Sweden

  • Uppsala University Hospital

    NOT_YET_RECRUITING

    Uppsala, Region Uppsala, 751 85, Sweden

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