ClinicalTrials.Veeva

Menu

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

The Chinese University of Hong Kong logo

The Chinese University of Hong Kong

Status and phase

Terminated
Phase 3

Conditions

Prostate Cancer

Treatments

Drug: Enzalutamide
Drug: Apalutamide

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT04409288
56021927PCR3012

Details and patient eligibility

About

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.

Full 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.

Enrollment

74 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

74 participants in 2 patient groups

Group A
Experimental group
Description:
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.
Treatment:
Drug: Enzalutamide
Drug: Apalutamide
Group B
Experimental group
Description:
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.
Treatment:
Drug: Enzalutamide
Drug: Apalutamide

Trial contacts and locations

1

Loading...

Central trial contact

Pui Tak LAI, BN; Chi Fai NG, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems