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

NCT ID: NCT03124615

Last Updated: 2017-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2021-06-30

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

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Enzalutamide

Intervention Type: DRUG

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

Interventions

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 Type: DRUG

Other Intervention Names

Xtandi

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Macquarie University, Australia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard Gurney

Role: PRINCIPAL_INVESTIGATOR

Medical Oncologist

Locations

Macquarie University

North Ryde, New South Wales, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Professor Gurney

Role: CONTACT

clinicaltrials@mq.edu.au

+61 2 9812 3526

Hung Tran

Role: CONTACT

clinicaltrials@mq.edu.au

+61 2 9812 3604

Facility Contacts

Hung Tran

Role: primary

clinicaltrials@mq.edu.au

+61 2 9812 3526

Other Identifiers

HGMQ201502

Identifier Type: -

Identifier Source: org_study_id