Effect of Enzalutamide Dose Reduction on Fatigue, Cognition, and Drug Trough Levels in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

— EFFECT  

Official title:

Effect of Enzalutamide Dose Reduction on Fatigue, Cognition, and Drug Trough Levels in Patients With Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03124615
• Other study ID #: HGMQ201502
• Status: Recruiting
• Phase: Phase 2
• First received: April 13, 2017
• Last updated: April 20, 2017
• Start date: May 2017
• Est. completion date: June 2021

Study information

• Verified date: April 2017
• Source: Macquarie University, Australia
• Contact: Professor Gurney
• Phone: +61 2 9812 3526
• Email: clinicaltrials[@]mq.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 47
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Fatigue
• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Australia	Macquarie University	North Ryde	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Macquarie University, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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