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NCT Number: NCT05762536

Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC

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.

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Key information

Conditions

Metastatic Castration-resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Erasmus MC Cancer Institute

Rotterdam, 3015GD, Netherlands

Location status: Recruiting

Location contact

Tanja van Dijk, MD

CONTACT

[email protected]

0031107040704

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years;
  • 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.
  • 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.
  • WHO performance ≤ 2
  • Able and willing to sign the Informed Consent Form prior to screening evaluations
  • Adequate haematological, renal and liver function and chemistry.

Exclusion criteria

  • Impossibility or unwillingness to take oral drugs
  • Hypersensitivity to taxanes
  • 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)
  • Symptomatic peripheral neuropathy CTCAE grade ≥2
  • Docetaxel-rechallenge.

Treatment and study plan

Darolutamide

Drug

Darolutamide 600 mg b.i.d. until the end of the last taxane cycle

Docetaxel or cabazitaxel

Drug

Docetaxel or cabazitaxel Q3W

Primary outcomes

  1. Progression free survival

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first

    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

Secondary outcomes

  1. Overall survival

    Time frame: From date of randomization until the date of death from any cause

    Overall survival, defined as time from randomization to death from any cause.

  2. Time to progression

    Time frame: From date of randomization until the date of first documented progression

    Time to progression, defined as time from randomization to radiologic, biochemical or pain progression, whichever occurs first.

  3. Time to PSA progression

    Time frame: From date of randomization until the date of first documented PSA progression

    Time to PSA progression, defined as time from randomization to biochemical progression.

Study contacts

Contact information is provided by the study sponsor or research team.

Tanja van Dijk

CONTACT

[email protected]

0031107040704

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

A Randomized Phase II Trial of Docetaxel or Cabazitaxel With or Without Darolutamide in Men With Metastatic Castration-resistant Prostate Cancer

Acronym: DAROTAXEL

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Mar 9, 2023
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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