DAROTAXEL
- Conditions
- metastatic castration-resistant prostate cancer
- Registration Number
- 2024-516939-28-00
- Brief Summary
To compare progression free survival (PFS) between treatment with docetaxel or cabazitaxel and darolutamide versus treatment with docetaxel or cabazitaxel in mCRPC patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Male
- Target Recruitment
- 245
Age ≥ 18 years;
A confirmed diagnosis of progressive mCRPC (progression according to Prostate cancer Working Group (PCWG) 3 criteria), with an indication for docetaxel or cabazitaxel. Progression defined as ≥ 1 of the following 3 criteria: a. Radiographic disease progression in soft tissue per RECIST v1.1 b. Radiographic disease progression in bone defined by the appearance of ≥ 2 new bone lesions on bone scan. c. PSA progression defined as ≥ 2 sequential rises in PSA obtained ≥ 1 week apart with a minimal starting value of ≥ 1 ng/mL. A PSA value ≥ 2 ng/mL is required at study entry.
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. Coadministration of docetaxel in mCNPC (triplet-therapy) is allowed.
WHO performance ≤ 2 (see appendix A)
Able and willing to sign the Informed Consent Form prior to screening evaluations
Adequate haematological, renal and liver function and chemistry, defined as: a. Hemoglobin ≥ 6.0 mmol/L b. Platelets ≥ 100 x 109/L c. ALT/AST ≤ 3x ULN and ≤ 5x ULN in case of liver metastases d. Creatinine clearance ≥ 50 ml/min e. Serum testosterone ≤ 1.7 nmol/L
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study endpoint is 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 (Appendix C). The main study endpoint is 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 (Appendix C).
- Secondary Outcome Measures
Name Time Method Overall survival, defined as time from randomization to death from any cause. Overall survival, defined as time from randomization to death from any cause.
Time to progression, defined as time from randomization to radiologic, biochemical or pain progression, whichever occurs first. Time to progression, defined as time from randomization to radiologic, biochemical or pain progression, whichever occurs first.
The time to PSA progression, defined as time from randomization to biochemical progression. The time to PSA progression, defined as time from randomization to biochemical progression.
The time to pain progression, defined as time from randomization to pain progression. The time to pain progression, defined as time from randomization to pain progression.
The number and severity of adverse events The number and severity of adverse events
Cell-free DNA aneuploidy scores and somatic aberrations in circulating tumor DNA Cell-free DNA aneuploidy scores and somatic aberrations in circulating tumor DNA
Differential expression of relevant genes, as measured in tissue and liquid biopsies. (comparing tissue and liquid biopsies at baseline and on-treatmen Differential expression of relevant genes, as measured in tissue and liquid biopsies. (comparing tissue and liquid biopsies at baseline and on-treatmen
Immune subset phenotyping and subtyping as measured in tissue and whole blood Immune subset phenotyping and subtyping as measured in tissue and whole blood
Trial Locations
- Locations (16)
Bravis Ziekenhuis
🇳🇱Roosendaal, Netherlands
Franciscus Gasthuis en Vlietland
🇳🇱Schiedam, Netherlands
Catharina Ziekenhuis Stichting
🇳🇱Eindhoven, Netherlands
Jeroen Bosch Ziekenhuis Stichting
🇳🇱'S-Hertogenbosch, Netherlands
Amsterdam UMC Stichting
🇳🇱Amsterdam, Netherlands
Amphia Hospital
🇳🇱Breda, Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
🇳🇱Rotterdam, Netherlands
Ziekenhuisgroep Twente Stichting
🇳🇱Almelo, Netherlands
Haga Hospital
🇳🇱's-Gravenhage, Netherlands
Canisius Wilhelmina Ziekenhuis
🇳🇱Nijmegen, Netherlands
Scroll for more (6 remaining)Bravis Ziekenhuis🇳🇱Roosendaal, NetherlandsSteve BoudewijnsSite contact+31887066820s.boudewijns@bravis.nl