Prostate cancer Pill-Taking habits under the microscope
NCT ID NCT07451002
First seen Jun 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times
Summary
This study tracks 270 men with metastatic hormone-sensitive prostate cancer to see how faithfully they take their apalutamide pills over the first year. Researchers will use questionnaires to measure adherence and identify who is at risk of skipping doses. The goal is to learn what factors affect real-world medication use, not to test a new treatment.
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 could help doctors understand which patients are likely to skip doses and why, leading to better support and possibly improved treatment outcomes.
- What could go wrong
- This is an observational study, not a treatment trial, so it won't test if apalutamide works better or worse. Results may not apply to all patients or settings.
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 540 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Sep 2028
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
Adult male (according to their chromosomal composition at birth) participants with confirmed diagnosis of mHSPC will be enrolled at the time of initiation of treatment with apalutamide.
- 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: * Male (based on chromosomal composition at birth) and aged greater than or equal to (\>=) 18 years. * Must have a histologically or cytologically confirmed diagnosis of prostate adenocarcinoma * Must have documented metastatic hormone-sensitive prostate cancer (mHSPC) * Must have agreed with the treating physician to initiate treatment with apalutamide (plus androgen-deprivation therapy \[ADT\]) in accordance with the current product characteristics summary, based on the physician's decision, prior to study inclusion * Able to understand the content of the patient information sheet and has provided oral consent for data collection. Has received the information sheet and has not objected to data collection * Must have a baseline prostate-specific antigen (PSA) level collected prior to the first administration of apalutamide. * Must agree to complete adherence and quality-of-life questionnaires during the study, including before the first administration of apalutamide Exclusion criteria: * Has already received or is currently receiving apalutamide, or any other androgen receptor pathway inhibitor (ARPI; including but not limited to abiraterone acetate, darolutamide, and enzalutamide) or chemotherapy for mHSPC * Has received an investigational drug (including vaccines) or used an invasive investigational medical device within 90 days prior to study start or data collection * Is currently receiving active treatment for prostate cancer as part of an interventional study * Has received ADT for mHSPC for more than 4 months prior to starting apalutamide treatment * Has experienced progression under ADT (and thus became castration-resistant) before starting apalutamide treatment * Beneficiary of State Medical Aid \[AME\] * Does not speak/read French * Under guardianship or curatorship * Under judicial protection
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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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Centre Francois Baclesse
RECRUITINGCaen, 14076, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human biologic JUR-003 put to the test against metastatic prostate cancer
- Can MRI spot which prostate cancers are safe to watch?
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- A proactive care plan may help men with prostate cancer live better
- Mapping the tumor microenvironment to predict prostate cancer therapy outcomes
- Radiation boost may extend Drug-Free time in prostate cancer recurrence