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The primary purpose of this trial is to determine whether dose reduction of enzalutamide in patients with grade 3 fatigue and/or cognition change will lead to an improvement in symptoms while maintaining active drug levels.
Patients within 3 months of starting enzalutamide will be assessed by their oncologist as being potentially eligible for dose reduction due to the onset of moderate to severe fatigue and/or cognition change, which is assessed as being due to enzalutamide
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide | Experimental | Patients will have commenced standard dose enzalutamide (160mg) daily and dose will be reduced if Grade 3 fatigue or cognition change has occurred and if toxicity is attributed to enzalutamide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | Enzalutamide is a FDA and Therapeutic Goods Administration (TGA, Regulatory Authority of therapeutic goods in Australia) approved treatment for castration resistant prostate cancer |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients who have an improvement in cognition/ fatigue symptoms | The primary endpoint is an improvement in the fatigue and cognition symptoms. Improvement will be de ned as the patient answering 'Better' in the cognition/ fatigue question at the lowest dose of enzalutamide. | 1 year post enrolment |
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Inclusion Criteria:
Exclusion Criteria:
The trial involves only the male population with prostate cancer
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Professor Gurney | Contact | +61 2 9812 3526 | clinicaltrials@mq.edu.au | |
| Hung Tran | Contact | +61 2 9812 3604 | clinicaltrials@mq.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Howard Gurney | Medical Oncologist | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macquarie University | Recruiting | North Ryde | New South Wales | 2109 | Australia |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
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Patients will have commenced standard dose enzalutamide (160mg) daily and dose will be reduced if Grade 3 fatigue or cognition change has occurred and if toxicity is attributed to enzalutamide
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|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |