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

NCT04409288 | Terminated Phase 3 FDA Drug

• 1 other identifier: 56021927PCR3012
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Patient Preference

Outcome Measures

Primary Outcomes (1)

• Patient Preference Questionnaire

  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 Outcomes (7)

• The side effect profile as assessed Patient Preference Questionnaire

  Baseline to week 29 (the end of the study)

• Physician Preference Questionnaire

  Week 29 (at the end of second treatment)

• Caregiver Preference Questionnaire

  Week 29 (at the end of second treatment)

• The Functional Assessment of Cancer Therapy-Prostate Questionnaire (FACT-P)

  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)

  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

Study Arms (2)

Group A

EXPERIMENTAL

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; Drug: Enzalutamide

Group B

EXPERIMENTAL

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; Drug: Enzalutamide

Interventions

Apalutamide DRUG

Androgen receptor inhibitor.

Group A; Group B

Enzalutamide DRUG

Androgern receptor inhibitor

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old or above with informed consent
• Histological diagnosis of adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
• Androgen deprivation therapy started at least 28 days prior to randomization
• Patients should be having one of the following diseases and treatment conditions:
• Recurrent prostate cancer following radical prostatectomy or radiotherapy, which do not fall into high-risk or high-volume categories
• Metastatic hormone-sensitive prostate cancer, which do not fall into high-risk or high-volume categories

You may not qualify if:

• 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
• 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
• Presence of brain metastasis
• Use of bisphosphonate or denosumab within 28 days prior to randomization
• Use of older anti-androgens, including flutamide and bicalutamide, for flare protection, within 28 days prior to randomization
• 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
• History of seizure or any condition that may predispose to seizure (e.g., neurological disorder, prior cortical stroke or significant brain trauma)
• Use of an investigational agent within 4 weeks of randomization
• Hypersensitivity reaction to the active pharmaceutical ingredient
• Clinically significant cardiovascular disease including the following:
• Myocardial infarction within 6 months before screening;
• Uncontrolled angina within 3 months before screening;
• 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%;
• History of clinically significant ventricular arrhythmias (e.g. sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes);
• History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place;

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Janssen, LP: collaborator

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

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MeSH Terms

Conditions

Prostatic Neoplasms; Patient Preference

Interventions

apalutamide; 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; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Chi Fai NG, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: July 20, 2020
• Primary Completion: October 16, 2023
• Study Completion: October 16, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)