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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Enzalutamide
Sponsored by
Macquarie University, Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Macquarie UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Enzalutamide

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 13, 2017
Last Updated
April 20, 2017
Sponsor
Macquarie University, Australia
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1. Study Identification

Unique Protocol Identification Number
NCT03124615
Brief Title
Effect of Enzalutamide Dose Reduction on Fatigue, Cognition, and Drug Trough Levels in Patients With Prostate Cancer
Acronym
EFFECT
Official Title
Effect of Enzalutamide Dose Reduction on Fatigue, Cognition, and Drug Trough Levels in Patients With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2017 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Macquarie University, Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enzalutamide
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
Xtandi
Intervention Description
Enzalutamide is a FDA and Therapeutic Goods Administration (TGA, Regulatory Authority of therapeutic goods in Australia) approved treatment for castration resistant prostate cancer
Primary Outcome Measure Information:
Title
The proportion of patients who have an improvement in cognition/ fatigue symptoms
Description
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.
Time Frame
1 year post enrolment

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
The trial involves only the male population with prostate cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Professor Gurney
Phone
+61 2 9812 3526
Email
clinicaltrials@mq.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Hung Tran
Phone
+61 2 9812 3604
Email
clinicaltrials@mq.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Gurney
Organizational Affiliation
Medical Oncologist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Macquarie University
City
North Ryde
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hung Tran
Phone
+61 2 9812 3526
Email
clinicaltrials@mq.edu.au
First Name & Middle Initial & Last Name & Degree
Howard Gurney, MBBS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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