Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer

January 3, 2024 updated by: Chi Fai NG, Chinese University of Hong Kong

Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer: An Open-label, Randomized, Cross-Over Trial.

This is a prospective, open-label, randomized, controlled, cross-over trial assessing patient preference for apalutamide versus enzalutamide in 146 male patients with recurrent or metastatic hormone-sensitive prostate cancer. The primary objective is to investigate whether there is any difference in patient preference between apalutamide and enzalutamide in patients with recurrent or metastatic hormone-sensitive prostate cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, open-label, randomized, controlled, cross-over trial assessing patient preference for apalutamide versus enzalutamide in 146 male patients with recurrent or metastatic hormone-sensitive prostate cancer The primary outcome is patient preference, which serves as an indicator covering different aspects of treatment-related effects, and this would be most important in a patient's perspective. The quality of life, psychological and cognitive changes following apalutamide and enzalutamide in a comprehensive manner will be investigated.

Patient will receive two 12-weeks treatment periods with a 5-week wash-out period between the treatment periods. Patients will receive Apalutamide and Enzulutamide sequentially. Patient, physician and caregiver preferences will be assessed at the end of the second treatment period. Other secondary outcomes on health-related quality of life measures, psychological assessment scores and cognitive assessment scores shall be assessed before and the end of first treatment and second treatment period.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18 years old or above with informed consent
  2. Histological diagnosis of adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  4. Androgen deprivation therapy started at least 28 days prior to randomization

  5. Patients should be having one of the following diseases and treatment conditions:

    1. Recurrent prostate cancer following radical prostatectomy or radiotherapy, which do not fall into high-risk or high-volume categories
    2. Metastatic hormone-sensitive prostate cancer, which do not fall into high-risk or high-volume categories

Exclusion Criteria:

  1. Patients with high-volume metastatic hormone-sensitive prostate cancer, defined by the presence of visceral metastases or four or more bone lesions with at least one beyond the vertebral bodies and pelvis
  2. Patients with high-risk metastatic hormone-sensitive prostate cancer, defined by having at least two of the three following factors - a Gleason score above 7, having at least 3 bone metastasis or presence of measurable visceral metastasis
  3. Presence of brain metastasis
  4. Use of bisphosphonate or denosumab within 28 days prior to randomization
  5. Use of older anti-androgens, including flutamide and bicalutamide, for flare protection, within 28 days prior to randomization
  6. Prior use of chemotherapy, immunotherapy, radiopharmaceutical agents, CYP17 inhibitors (e.g. abiraterone acetate), enzalutamide or apalutamide for the treatment of prostate cancer or prior participation in a clinical trial of an investigational agent that inhibits the androgen receptor or androgen synthesis
  7. History of seizure or any condition that may predispose to seizure (e.g., neurological disorder, prior cortical stroke or significant brain trauma)
  8. Use of an investigational agent within 4 weeks of randomization
  9. Hypersensitivity reaction to the active pharmaceutical ingredient

  10. Clinically significant cardiovascular disease including the following:

    1. Myocardial infarction within 6 months before screening;
    2. Uncontrolled angina within 3 months before screening;
    3. Congestive heart failure New York Heart Association class 3 or 4, or a history of congestive heart failure New York Heart Association class 3 or 4, unless a screening echocardiogram or multigated acquisition scan performed within 3 months before randomization demonstrates a left ventricular ejection fraction ≥ 50%;
    4. History of clinically significant ventricular arrhythmias (e.g. sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes);
    5. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place;
    6. Hypotension as indicated by systolic blood pressure < 86 millimeters of mercury (mm Hg) at screening;
    7. Bradycardia as indicated by a heart rate of < 45 beats per minute on the screening electrocardiogram and on physical examination;
    8. Uncontrolled hypertension as indicated by systolic blood pressure > 170 mm Hg or diastolic blood pressure > 105 mm Hg at screening
  11. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within 3 months before randomization)
  12. Major surgery within 28 days of randomization
  13. Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Apalutamide followed by Enzalutamide Study participants will receive 12 weeks of oral apalutamide (240mg) daily, followed by five weeks of washout period, and then 12 weeks of oral enzalutamide (160mg) daily.
Drug: Apalutamide
Androgen receptor inhibitor.
Drug: Enzalutamide
Androgern receptor inhibitor
Experimental: Group B
Enzalutamide followed by Apalutamide Study participants will receive 12 weeks of oral enzalutamide (160mg) daily, followed by five weeks of washout period, and then 12 weeks of oral apalutamide (240mg) daily.
Drug: Apalutamide
Androgen receptor inhibitor.
Drug: Enzalutamide
Androgern receptor inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Preference Questionnaire
Time Frame: Week 29 (at the end of second treatment)
This Patient Preference Questionnaire consists of 4 questions, assessing the patients preference on Apalutamide verse Enzalutamide, the factors that had an influence on their treatment preference, the most important reason for their preference and the side effect of first treatment and second treatment.
Week 29 (at the end of second treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The side effect profile as assessed Patient Preference Questionnaire
Time Frame: Baseline to week 29 (the end of the study)
In Patient Preference Questionnaire, participants completed a sideffect checklist.
Baseline to week 29 (the end of the study)
Physician Preference Questionnaire
Time Frame: Week 29 (at the end of second treatment)
This Physician Preference Questionnaire consists of 3 questions, assessing the physicians preference on Apalutamide verse Enzalutamide, the factors that had an influence on their treatment preference, the most important reason for their preference.
Week 29 (at the end of second treatment)
Caregiver Preference Questionnaire
Time Frame: Week 29 (at the end of second treatment)
This Caregiver Preference Questionnaire consists of 3 questions, assessing the caregivers preference on Apalutamide verse Enzalutamide, the factors that had an influence on their treatment preference, the most important reason for their preference.
Week 29 (at the end of second treatment)
The Functional Assessment of Cancer Therapy-Prostate Questionnaire (FACT-P)
Time Frame: Week 0 (before start of first treatment period), Week 12 (end of first treatment period), week 17 (before start of second treatment period) and Week 29 (end of second treatment period).
This is a 39-item questionnaire assessing five domains including Physical Well-Being, Social and Family Well-Being, Emotional Well-Being, Functional Well-Being and Prostate Cancer Subscale.The higher the score, the better the QOL
Week 0 (before start of first treatment period), Week 12 (end of first treatment period), week 17 (before start of second treatment period) and Week 29 (end of second treatment period).
Quality of life measured by EurolQol instrument (EQ-5D-5L)
Time Frame: Week 0 (before start of first treatment period), Week 12 (end of first treatment period), week 17 (before start of second treatment period) and Week 29 (end of second treatment period
This questionnaire consists of two parts, namely the EQ-5D-5L Descriptive System and the EQ Visual Analog Scale, the higher the score the better in quality of life
Week 0 (before start of first treatment period), Week 12 (end of first treatment period), week 17 (before start of second treatment period) and Week 29 (end of second treatment period
FACT-Cognitive Function Version 3 (FACT-Cog)
Time Frame: Week 0 (before start of first treatment period), Week 12 (end of first treatment period), week 17 (before start of second treatment period) and Week 29 (end of second treatment period
This is a well-established 37-item questionnaire assessing patients' perceived cognitive impairments, perceived cognitive abilities, noticeability or comments from others, and impact of cognitive changes on quality of life. The higher the score, the better the QOL.
Week 0 (before start of first treatment period), Week 12 (end of first treatment period), week 17 (before start of second treatment period) and Week 29 (end of second treatment period
Brief Fatigue Inventory (BFI)
Time Frame: Week 0 (before start of first treatment period), Week 12 (end of first treatment period), week 17 (before start of second treatment period) and Week 29 (end of second treatment period
This is a well-established 9-item questionnaire assessing patients' degree of fatigue.The higher the score, the higher fatigue level
Week 0 (before start of first treatment period), Week 12 (end of first treatment period), week 17 (before start of second treatment period) and Week 29 (end of second treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Janssen, LP

Investigators

  • Principal Investigator: Chi Fai NG, MD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2020

Primary Completion (Actual)

October 16, 2023

Study Completion (Actual)

October 16, 2023

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

May 27, 2020

First Posted (Actual)

June 1, 2020

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56021927PCR3012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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