Chemotherapy with or without darolutamide in men with metastatic prostate cancer.

Phase 1

• Conditions: metastatic castration-resistant prostate cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2022-003792-41-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-23
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 245

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. Co-administration of docetaxel in mCNPC (triplet-therapy) is allowed.
4.WHO performance = 1 (see appendix A)
5.Able and willing to sign the Informed Consent Form prior to screening evaluations
6.Adequate haematological, renal and liver function and chemistry.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 245
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 245

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified