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New genetic test may predict prostate cancer drug response before surgery

NCT ID NCT07617272

Knowledge-focused Sponsor: Region Stockholm Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a new genetic test (called PCAI ImmunoScore) can predict how well men with high-risk prostate cancer will respond to the drug darolutamide before surgery. About 100 participants will take darolutamide for 3-4 months, then have their prostate removed. Researchers will check if the genetic test matches the actual tumor shrinkage seen after surgery. The goal is to better identify who benefits from this treatment approach.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

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

Started

Nov 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

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: * Biopsy-confirmed high-risk prostate cancer defined as: Global ISUP score \> 3 with any MRI PI-RADS score OR Global ISUP score = 3 with MRI PI-RADS score = 5 * Candidate for radical prostatectomy * Clinical prostate MRI not older than 3 months at screening * ECOG performance status score of 0 or 1 * Able to receive Darolutamide for 90-120 days * Signed informed consent form * Willingness to use contraception if sexually active Exclusion Criteria: * Metastatic (M1) or node-positive (N2) disease * Prior treatment with androgen receptor antagonists * Prior treatment with gonadotropin-releasing hormone (GnRH) * History of prior systemic or local therapy for prostate cancer (including radiation and focal therapy) * Major surgery \<4 weeks prior to inclusion

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Conditions

The condition(s) this trial relates to.

adenocarcinoma prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer (adenocarcinoma)

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

  • Karolinska University Hospital

    RECRUITING

    Stockholm, SE-17176, Sweden

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, Sweden

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