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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05762536
Other study ID # NL83539.078.23
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 19, 2023
Est. completion date May 2028

Study information

Verified date October 2023
Source Erasmus Medical Center
Contact Tanja van Dijk
Phone 0031107040704
Email interne.oncologie@erasmusmc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 245
Est. completion date May 2028
Est. primary completion date May 2027
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Darolutamide
Darolutamide 600 mg b.i.d. until the end of the last taxane cycle
Docetaxel or cabazitaxel
Docetaxel or cabazitaxel Q3W

Locations

Country Name City State
Netherlands Erasmus MC Cancer Institute Rotterdam

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression free survival progression free survival, which is defined as time from randomization to radiologic, biochemical or pain progression or death from any cause, whichever occurs first, according to PCWG3 From date of randomization until the date of first documented progression or date of death from any cause, whichever came first
Secondary Overall survival Overall survival, defined as time from randomization to death from any cause. From date of randomization until the date of death from any cause
Secondary Time to progression Time to progression, defined as time from randomization to radiologic, biochemical or pain progression, whichever occurs first. From date of randomization until the date of first documented progression
Secondary Time to PSA progression Time to PSA progression, defined as time from randomization to biochemical progression. From date of randomization until the date of first documented PSA progression
See also
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