Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC) — DaroAcT

Prostatic Cancer, Castration-Resistant Clinical Trial

Official title:
A Randomized, Open-label, Multicenter, Phase 2b Study to Evaluate Physical Function, Including Balance and Daily Activity, in Participants With Castration-resistant Prostate Cancer Treated With Darolutamide or Enzalutamide

Status Terminated

Clinical Trial Summary

Researchers in this study want to compare the effects of drug darolutamide and drug enzalutamide on physical function, including balance and daily activity, in patients with castration-resistant prostate cancer (CRPC). Both darolutamide and enzalutamide are approved AR inhibitors used for the treatment of patients with CRPC. AR inhibitor is a substance that keeps androgens (male sex hormones) from binding to proteins called androgen receptors, which are found in normal prostate cells, some prostate cancer cells, and in some other cells. Preventing this binding blocks the effects of these hormones in the body and therefore keeps prostate cancer cells from growing. Patients participating this study will receive either darolutamide or enzalutamide tablets. To evaluate the physical function, patients will be asked to make some movements like rising from a chair, walking three meters, etc. Additionally, researchers also want to find out the survival of patients and if patients have fatigue (feeling tired), cognitive (learning and thinking) problems, or other medical problems during the trial. Brand name of darolutamide is Nubeqa; brand name of enzalutamide is Xtandi.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Prostatic Cancer, Castration-Resistant
Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant

Clinical Trial Details

NCT number	NCT04157088
Study type	Interventional
Source	Bayer
Contact
Status	Terminated
Phase	Phase 2
Start date	December 17, 2019
Completion date	July 8, 2022

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT02866916` - Study of SXL01 in Patients With Metastatic Castration-Resistant Prostate Cancer (PROSTIRNA)	Phase 1
Active, not recruiting	`NCT04381832` - Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer	Phase 1/Phase 2
Not yet recruiting	`NCT06276465` - Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging	Phase 3
Recruiting	`NCT04141709` - Local Ablative Radiotherapy for OLIgoprogressive Castration Resistant Prostate Cancer	N/A