Could a lower dose of enzalutamide work better for elderly prostate cancer patients?
NCT ID NCT07512076
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing four different doses of enzalutamide (40, 80, 120, and 160 mg) in men aged 75 and older with advanced prostate cancer. The goal is to see how drug levels in the blood differ between older and younger patients, and to find the safest and most effective dose. The study will enroll 26 participants and may adjust doses after 8 weeks based on how well the treatment is working.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- enzalutamide
- What this could lead to
- If successful, this study could help doctors choose the right enzalutamide dose for older patients, potentially improving treatment outcomes and reducing side effects.
- What could go wrong
- This is a small, early-phase study with only 26 participants, so results may not apply to all patients. It focuses on drug levels in the blood, not direct proof of better cancer control.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
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.
- Ages
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18 years and older
- Sex
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Female 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: Main Cohort: 1. Male aged 75 years or older. 2. Signed Informed Consent Form 3. Advanced prostate cancer with a Health Canada approved indication for enzalutamide amongst the following: 1. High-risk biochemical recurrent hormone sensitive prostate cancer (high risk definition: PSA doubling time of ≤9 months and a PSA level of ≥2 ng per milliliter above nadir after radiation therapy or ≥1 ng per milliliter after radical prostatectomy with or without postoperative radiation therapy). 2. Metastatic castration-sensitive prostate cancer. 3. Non-metastatic castration-resistant prostate cancer (M0CRPC) with a PSA doubling time of ≤9 months 4. Participants must receive concomitant androgen deprivation therapy with either a Luteinizing hormone-releasing hormone (LHRH) antagonist or agonist, or have had bilateral orchiectomy. 5. Participant is capable, in the opinion of the investigator, of completing all study assessments and procedures, including blood draws for PK sampling according to the required schedule as per the study protocol as well as PROs. 1. Note, for patients who speak a language other than English, PROs may be completed with the help of an interpreter, or translated PROs may be substituted, if available in the patient's primary language. Control Cohort: 1. Age \< 70 years 2. Receiving enzalutamide for advanced prostate, for any indication as per Product Monograph 3. Receiving the same dose of enzalutamide taken daily and fully compliant for ≥ 29 days 4. Signed Informed Consent Form Exclusion Criteria: Main Cohort: 1. Metastatic castration-resistant prostate cancer 2. Pain related to bone metastasis requiring the use of opioid analgesics 3. Impending spinal cord compression related to metastasis to vertebral column 4. Painful femoral neck or any other metastasis judged to be at risk of short-term pathological fracture in the investigator's opinion 5. Co-administration of medications which are moderate to strong CYP2C8 inducers or inhibitors 6. Co-administration of medications which are moderate to strong CYP3A4 inducers or inhibitors 7. History of seizure disorder 8. History of moderate-severe dementia 9. Performance status \> ECOG 2 10. Uncontrolled hypertension (defined as sustained systolic blood pressure above 160 and/or diastolic above 100 despite the adequate use of antihypertensive medication) 11. Participants with a known history of dementia, seizure disorder, intracranial lesions, moderate to severe hepatic impairment, stage ≥ 3 chronic renal failure or stroke will also be excluded Control Cohort: 1. Unable to provide written informed consent 2. Receiving a medication which is a moderate-strong CYP2C8 or CYP3A4 inducer or inhibitor
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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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Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
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