Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05762536
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2023-02-17
Brief Title:
Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
A Randomized Phase II Trial of Docetaxel or Cabazitaxel With or Without Darolutamide in Men With Metastatic Castration-resistant Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAROTAXEL
Brief Summary:
Taxane efficacy in metastatic prostate cancer is modest due to resistance development Several clinical phase III studies in metastatic castration-naïve prostate cancer mCNPC patients have shown that adding an androgen receptor signalling inhibitor ARSi to patients receiving a taxane and androgen deprivation therapy ADT improves survival endpoints Adding ARSi darolutamide to docetaxelADT in mCNPC patients resulted in a robust OS benefit HR 068 Importantly the combination of a taxane and darolutamide is not prone to a drug-drug interaction while there is a detrimental CYP3A4 inducing effect in the case of enzalutamide resulting in a significant and clinically relevant reduction of cabazitaxel plasma concentrations The investigators have previously reported preclinical data showing that addition of an androgen receptor signaling inhibitor ARSi improves cabazitaxel efficacy even in metastatic castration-resistant prostate cancer mCRPC As treatment options for mCRPC patients are scarce and patients often develop drug resistance relatively early a new treatment regimen for this population to delay drug resistance is highly desired The investigators propose a randomized phase II trial to investigate the efficacy of docetaxel or cabazitaxel plus darolutamide compared to docetaxel or cabazitaxel monotherapy in men with metastatic CRPC who have progressed on an ARSI
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None