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New study tracks how apalutamide works outside of clinical trials

NCT ID NCT06019676

Knowledge-focused Sponsor: Royal Marsden NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This observational study follows 170 men with metastatic hormone-sensitive prostate cancer who are taking apalutamide as part of their standard care. Researchers will measure PSA levels and use questionnaires to assess fatigue, thinking skills, and quality of life over two years. The goal is to see how well the drug works in everyday practice, beyond the strict conditions of earlier clinical trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
apalutamide
What this could lead to
If successful, this study could provide real-world evidence on how well apalutamide works and its side effects, helping doctors make better treatment decisions for men with metastatic prostate cancer.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It only includes men already choosing apalutamide, which may limit how broadly findings apply.

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

170 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Apr 2027

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

Males 18 years of age or older, with metastatic hormone sensitive 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 * Histologically confirmed diagnosis of adenocarcinoma of the prostate with both: * Metastatic hormone sensitive prostate cancer * Treatment decision for apalutamide by clinician Exclusion Criteria: * Non-metastatic prostate cancer * Prior chemotherapy / abiraterone / apalutamide / darolutamide / enzalutamide for prostate cancer * Unable to complete patient reported outcome questionnaires

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma

As listed by the trial registrant

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

Metastatic hormone-sensitive prostate cancer (MHSPC)

Contacts and locations

Locations

  • Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ, United Kingdom

  • Buckinghamshire Healthcare NHS Trust

    Aylesbury, HP21 8AL, United Kingdom

  • Clatterbrdige Cancer Centre, NHS Foundation Trust

    Liverpool, CH63 4JY, United Kingdom

  • East Lancashire Hospitals NHS Trust

    Blackburn, BB2 3HH, United Kingdom

  • Freeman Hospital, The Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle, NE7 7DN, United Kingdom

  • Northern Ireland Cancer Centre, Belfast Health & Social Care Trust

    Belfast, BT9 7AB, United Kingdom

  • South Tyneside and Sunderland NHS Foundation Trust

    Newcastle, NE34 0PL, United Kingdom

  • The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust

    Middlesbrough, TS4 3BW, United Kingdom

  • The Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT, United Kingdom

  • The University Hospital of North Tees

    Stockton-on-Tees, TS19 8PE, United Kingdom

  • University Hospitals of Morecambe Bay NHS Foundation Trust

    Lancaster, LA1 4RP, United Kingdom

  • Velindre Cancer Centre, Velindre University NHS Trust

    Cardiff, CF14 2TL, United Kingdom

More trials for these conditions

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