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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03124615




Registration number
NCT03124615
Ethics application status
Date submitted
13/04/2017
Date registered
24/04/2017
Date last updated
24/04/2017

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
HGMQ201502
Universal Trial Number (UTN)
Trial acronym
EFFECT
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
Prostate

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
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
enzalutamide)

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
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinical dementia

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

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
Treatment
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
Phase 2
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Primary sponsor type
Other
Name
Macquarie University, Australia
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/show/NCT03124615
Trial related presentations / publications
Public notes

Contacts
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
clinicaltrials@mq.edu.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03124615