Docetaxel + Degarelix for Prostate Cancer
Trial Summary
What is the purpose of this trial?
The purpose of this study is to look at patient outcomes when docetaxel is started prior to ADT with degarelix.
Eligibility Criteria
Men over 18 with newly diagnosed metastatic prostate cancer, who haven't had certain previous treatments for it. They should have a specific blood cell count, no brain or severe heart conditions, and not be HIV-positive. Participants must agree to use birth control during the trial and have an ECOG performance status of 0-2.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive docetaxel for up to 6 cycles every 21 days, followed by degarelix starting from cycle 5
Follow-up
Participants are monitored for safety and effectiveness after treatment, including PSA response and adverse events
Extension
Degarelix continues to be administered every 28 days for 5 more doses after the initial treatment phase
Treatment Details
Interventions
- Degarelix
- Docetaxel
Degarelix is already approved in European Union, United States, Canada, Japan for the following indications:
- Advanced hormone-dependent prostate cancer
- Advanced prostate cancer
- Hormone-sensitive prostate cancer
- Prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medical University of South Carolina
Lead Sponsor
Ferring Pharmaceuticals
Industry Sponsor
Pierre-Yves Berclaz
Ferring Pharmaceuticals
Chief Medical Officer since 2023
MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine
Jean-Frédéric Paulsen
Ferring Pharmaceuticals
Chief Executive Officer since 2023
Master’s degree in Finance from the London School of Economics and Political Science