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

NCT03124615 | Unknown Phase 2

• 1 other identifier: HGMQ201502
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Drug: Enzalutamide

Interventions

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

Also known as: Xtandi

Enzalutamide

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The trial involves only the male population with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with prostate cancer who have commenced enzalutamide within 3 months
• Patient must have concomitant LHRH agonist or antagonist (no single agent enzalutamide)
• Receiving enzalutamide before or after docetaxel
• Patients may have hormone-sensitive or castrate resistant disease
• Patients may have metastatic (M1) or non-metastatic (M0) disease
• Onset of grade 3 or more cognition change and/or fatigue after commencement of enzalutamide considered to be due to enzalutamide

You may not qualify if:

• Clinical dementia
• Concomitant use of drugs known to impair cognition such as benzodiazepines or antihistamines.
• Concomitant use of strong CYP3A4 and/ or CYP2C8 inducers or inhibitors.
• Patient expected to have a change in opioid dose during the study period or have had a change 4 weeks before study entry.
• Diagnosed with sleep apnoea
• Brain metastases, prior seizures, drugs that significantly reduce seizure threshold.
• Active infection or other intercurrent illness that may contribute to fatigue or cognition change within 4 weeks of study entry.

Sponsors & Collaborators

• Macquarie University, Australia: lead

Study Sites (1)

Macquarie University

North Ryde, New South Wales, 2109, Australia

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

enzalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Howard Gurney

  Medical Oncologist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor Gurney

CONTACT

+61 2 9812 3526; clinicaltrials@mq.edu.au

Hung Tran

CONTACT

+61 2 9812 3604; clinicaltrials@mq.edu.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 13, 2017
• First Posted: April 24, 2017
• Study Start: May 1, 2017
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: April 24, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)