Prostate Cancer PatientsPhase 2NCT07512076
A Dose Optimization Study of Enzalutamide in Elderly Patients With Advanced Prostate Cancer
A Phase 2 study testing Enzalutamide Dose Escalation in people with Prostate Cancer Patients and Elderly Patients, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This is a phase II, single-centre, pragmatic, non-randomized, dose escalation study to evaluate optimal dose levels of enzalutamide in elderly patients using pharmacokinetic blood sampling concentrations. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prostate Cancer Patients, Elderly Patients, Pharmacokinetic Study
- What is being tested?
- Enzalutamide Dose Escalation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2026to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Main Cohort:
- Male aged 75 years or older.
- Signed Informed Consent Form
- Advanced prostate cancer with a Health Canada approved indication for enzalutamide amongst the following:
- 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).
- Metastatic castration-sensitive prostate cancer.
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- Non-metastatic castration-resistant prostate cancer (M0CRPC) with a PSA doubling time of ≤9 months
- Participants must receive concomitant androgen deprivation therapy with either a Luteinizing hormone-releasing hormone (LHRH) antagonist or agonist, or have had bilateral orchiectomy.
- 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.
- 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:
- Age < 70 years
- Receiving enzalutamide for advanced prostate, for any indication as per Product Monograph
- Receiving the same dose of enzalutamide taken daily and fully compliant for ≥ 29 days
- Signed Informed Consent Form
Who cannot join
- Main Cohort:
- Metastatic castration-resistant prostate cancer
- Pain related to bone metastasis requiring the use of opioid analgesics
- Impending spinal cord compression related to metastasis to vertebral column
- Painful femoral neck or any other metastasis judged to be at risk of short-term pathological fracture in the investigator's opinion
- Co-administration of medications which are moderate to strong CYP2C8 inducers or inhibitors
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- Co-administration of medications which are moderate to strong CYP3A4 inducers or inhibitors
- History of seizure disorder
- History of moderate-severe dementia
- Performance status > ECOG 2
- Uncontrolled hypertension (defined as sustained systolic blood pressure above 160 and/or diastolic above 100 despite the adequate use of antihypertensive medication)
- 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:
- Unable to provide written informed consent
- Receiving a medication which is a moderate-strong CYP2C8 or CYP3A4 inducer or inhibitor
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Elyse Watkins contact
Canada1 site
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Daniel Khalaf, MD, 416-480-4617, daniel.khalaf@sunnybrook.ca
Daniel Khalaf, MD
About this study
This is a phase II, single-centre, pragmatic, non-randomized, dose escalation study to evaluate optimal dose levels of enzalutamide in elderly patients using pharmacokinetic blood sampling concentrations.
Read the detailed description
Enzalutamide is an androgen receptor pathway inhibitor (ARPI) drug that is commonly used in prostate cancer. It is safe, effective, and is generally well tolerated by patients at the standard dose of 160mg, however researchers have seen that it may cause unfavorable side effects in elderly patients 75 and older such as fatigue and cognitive impairment that impact their quality of life more significantly than those under 75.
To date there is limited research comparing differences in side effects and quality of life experienced by elderly patients on standard versus a lower dose of enzalutamide. Dose reductions are common, particularly in elderly patients, although they are not explicitly recommended on the drug label, and as a result this study seeks to build on the existing research and practice experience to evaluate how enzalutamide is metabolized in elderly patients and whether this difference warrants different dosing standards in these patients.
- Being tested
- Enzalutamide Dose Escalation, Standard of Care
- Keywords
- prostate cancer, enzalutamide, elderly patients
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enzalutamide Dose EscalationDrug
Participants will be allocated to receive one of 4 dose levels of enzalutamide;
- Level 1: 40mg
- Level 2: 80mg
- Level 3: 120mg
- Level 4: 160mg
There will be 4 participants per dose level. After 8 weeks of treatment at the initial dose level, the study doctor will review treatment progress and may escalate to a higher dose level at their discretion. For each dose level participants move up to (if applicable), they will repeat this same 8 weeks of treatment and evaluation process.
Standard of CareDrug
Participants will continue to receive enzalutamide per standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Main Cohort | Experimental | Participants 75 years and older who have have a confirmed diagnosis of advanced prostate cancer, and are suitable candidates to receive enzalutamide but have not started treatment with the drug yet. Receives: Drug: Enzalutamide Dose Escalation |
| Control Cohort | Active comparator | The control cohort will enroll participants that are under 70 years old, and are currently receiving enzalutamide for a period of more than 29 days. Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enzalutamide Plasma Levels
To compare enzalutamide plasma concentrations in patients ≥ 75 years of age with younger patients at various dose levels.
Measured: At day 29 and 57 of all applicable dose levels, up to 32 weeks maximum (4 levels, 8 weeks apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Khalaf, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512076
- Sponsor's protocol ID
- 6986
- Status last verified
- Mar 2026
- First submitted
- 25 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Optimization Study of Enzalutamide in Elderly Patients With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT07512076
- Acronym / sponsor ID
- 6986
- Keywords
- prostate cancer, enzalutamide, elderly patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, single-centre, pragmatic, non-randomized, dose escalation study to evaluate optimal dose levels of enzalutamide in elderly patients using pharmacokinetic blood sampling concentrations.
Detailed description
Enzalutamide is an androgen receptor pathway inhibitor (ARPI) drug that is commonly used in prostate cancer. It is safe, effective, and is generally well tolerated by patients at the standard dose of 160mg, however researchers have seen that it may cause unfavorable side effects in elderly patients 75 and older such as fatigue and cognitive impairment that impact their quality of life more significantly than those under 75.
To date there is limited research comparing differences in side effects and quality of life experienced by elderly patients on standard versus a lower dose of enzalutamide. Dose reductions are common, particularly in elderly patients, although they are not explicitly recommended on the drug label, and as a result this study seeks to build on the existing research and practice experience to evaluate how enzalutamide is metabolized in elderly patients and whether this difference warrants different dosing standards in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main Cohort | Experimental | Drug: Enzalutamide Dose EscalationParticipants 75 years and older who have have a confirmed diagnosis of advanced prostate cancer, and are suitable candidates to receive enzalutamide but have not started treatment with the drug yet. |
| Control Cohort | Active comparator | Drug: Standard of CareThe control cohort will enroll participants that are under 70 years old, and are currently receiving enzalutamide for a period of more than 29 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Male aged 75 years or older.
- Signed Informed Consent Form
- Advanced prostate cancer with a Health Canada approved indication for enzalutamide amongst the following:
- Participants must receive concomitant androgen deprivation therapy with either a Luteinizing hormone-releasing hormone (LHRH) antagonist or agonist, or have had bilateral orchiectomy.
- 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.
Key exclusion criteria (15 listed)
- Metastatic castration-resistant prostate cancer
- Pain related to bone metastasis requiring the use of opioid analgesics
- Impending spinal cord compression related to metastasis to vertebral column
- Painful femoral neck or any other metastasis judged to be at risk of short-term pathological fracture in the investigator's opinion
- Co-administration of medications which are moderate to strong CYP2C8 inducers or inhibitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enzalutamide Dose EscalationParticipants will be allocated to receive one of 4 dose levels of enzalutamide; * Level 1: 40mg * Level 2: 80mg * Level 3: 120mg * Level 4: 160mg There will be 4 participants per dose level. After 8 weeks of treatment at the initial dose level, the study doctor will review treatment progress and may escalate to a higher dose level at their discretion. For each dose level participants move up to (if applicable), they will repeat this same 8 weeks of treatment and evaluation process. | Drug | Main Cohort |
| Standard of CareParticipants will continue to receive enzalutamide per standard of care. | Drug | Control Cohort |
Primary outcome
Enzalutamide Plasma Levels
Time frame: At day 29 and 57 of all applicable dose levels, up to 32 weeks maximum (4 levels, 8 weeks apart)
To compare enzalutamide plasma concentrations in patients ≥ 75 years of age with younger patients at various dose levels.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elyse Watkins contact
Daniel Khalaf, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enzalutamide Dose Escalation in people with Prostate Cancer Patients and Elderly Patients, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel Khalaf, MD (416-480-4617, daniel.khalaf@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enzalutamide Plasma Levels (time frame: At day 29 and 57 of all applicable dose levels, up to 32 weeks maximum (4 levels, 8 weeks apart)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.