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Trial Title:
Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC
NCT ID:
NCT05762536
Condition:
Metastatic Castration-resistant Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Docetaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Darolutamide
Description:
Darolutamide 600 mg b.i.d. until the end of the last taxane cycle
Arm group label:
Docetaxel or cabazitaxel with darolutamide
Intervention type:
Drug
Intervention name:
Docetaxel or cabazitaxel
Description:
Docetaxel or cabazitaxel Q3W
Arm group label:
Docetaxel or cabazitaxel (SOC)
Arm group label:
Docetaxel or cabazitaxel with darolutamide
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 docetaxel+ADT in mCNPC patients resulted in a
robust OS benefit (HR 0.68). 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years;
2. A confirmed diagnosis of progressive mCRPC (progression according to Prostate cancer
Working Group (PCWG) 3 criteria, castration defined as castrate levels of
testosterone of <0.5 ng/mL) with an indication for docetaxel or cabazitaxel.
3. Patients should have had disease progression previously on at least one ARSi
(abiraterone, apalutamide, darolutamide or enzalutamide). ARSi administration is
allowed both in the mCNPC and in the mCRPC setting. Previous co-administration of
docetaxel in mCNPC (triplet-therapy) is allowed, if patients will receive
cabazitaxel in this study.
4. WHO performance ≤ 2
5. Able and willing to sign the Informed Consent Form prior to screening evaluations
6. Adequate haematological, renal and liver function and chemistry.
Exclusion Criteria:
1. Impossibility or unwillingness to take oral drugs
2. Hypersensitivity to taxanes
3. Known serious illness or medical unstable conditions that could interfere with this
study requiring treatment (e.g. HIV, hepatitis, Varicella zoster or herpes zoster,
organ transplants, kidney failure, serious liver disease (e.g. severe cirrhosis),
cardiac and respiratory diseases)
4. Symptomatic peripheral neuropathy CTCAE grade ≥2
5. Docetaxel-rechallenge.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Erasmus MC Cancer Institute
Address:
City:
Rotterdam
Zip:
3015GD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Tanja van Dijk, MD
Phone:
0031107040704
Email:
interne.oncologie@erasmusmc.nl
Start date:
November 29, 2023
Completion date:
May 2028
Lead sponsor:
Agency:
Erasmus Medical Center
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05762536
