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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Effect of Enzalutamide Dose Reduction on Fatigue, Cognition, and Drug Trough Levels in Patients With Prostate Cancer
Scientific title
Effect of Enzalutamide Dose Reduction on Fatigue, Cognition, and Drug Trough Levels in Patients With Prostate Cancer
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Enzalutamide

Experimental: Enzalutamide - 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

Treatment: Drugs: Enzalutamide
Enzalutamide is a FDA and Therapeutic Goods Administration (TGA, Regulatory Authority of therapeutic goods in Australia) approved treatment for castration resistant prostate cancer

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
1 year post enrolment

Key inclusion criteria
1. Patients with prostate cancer who have commenced enzalutamide within 3 months

2. Patient must have concomitant LHRH agonist or antagonist (no single agent

3. Receiving enzalutamide before or after docetaxel

4. Patients may have hormone-sensitive or castrate resistant disease

5. Patients may have metastatic (M1) or non-metastatic (M0) disease

6. Onset of grade 3 or more cognition change and/or fatigue after commencement of
enzalutamide considered to be due to enzalutamide
Minimum age
18 Years
Maximum age
No limit
Can healthy volunteers participate?
Key exclusion criteria
1. Clinical dementia

2. Concomitant use of drugs known to impair cognition such as benzodiazepines or

3. Concomitant use of strong CYP3A4 and/ or CYP2C8 inducers or inhibitors.

4. Patient expected to have a change in opioid dose during the study period or have had a
change 4 weeks before study entry.

5. Diagnosed with sleep apnoea

6. Brain metastases, prior seizures, drugs that significantly reduce seizure threshold.

7. Active infection or other intercurrent illness that may contribute to fatigue or
cognition change within 4 weeks of study entry.

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Macquarie University - North Ryde
Recruitment postcode(s) [1] 0 0
2109 - North Ryde

Funding & Sponsors
Primary sponsor type
Macquarie University, Australia

Ethics approval
Ethics application status

Brief summary
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
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Howard Gurney
Address 0 0
Medical Oncologist
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Professor Gurney
Address 0 0
Country 0 0
Phone 0 0
+61 2 9812 3526
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see