Docetaxel + Degarelix for Prostate Cancer

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Medical University of South Carolina

Must not be taking: Androgen deprivation therapy

Disqualifiers: CNS metastases, Active cardiac disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 18 weeks

52 Participants Needed

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

My vital organs are functioning well.

My prostate cancer is confirmed by lab tests.

I agree to use barrier contraception during and for a month after my docetaxel treatment.

Exclusion Criteria

I have been on anti-androgen therapy for more than 30 days before starting this study.

I've had over 3 years of hormone therapy with surgery or radiation for prostate cancer.

I haven't had cancer treatment in the last 5 years, except for skin cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive docetaxel for up to 6 cycles every 21 days, followed by degarelix starting from cycle 5

18 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including PSA response and adverse events

10 months

Extension

Degarelix continues to be administered every 28 days for 5 more doses after the initial treatment phase

5 months

Treatment Details

Interventions

• Degarelix
• Docetaxel

Trial Overview The study is testing the effectiveness of starting treatment with Docetaxel before Degarelix in managing metastatic prostate cancer. It's a Phase II trial focusing on patient outcomes with this sequence of drug administration.

Participant Groups

Group I: Docetaxel + Degarelix Experimental Treatment 2 Interventions

Docetaxel (TAXOTERE) will be given for up to 6 cycles every 21 days. During the 5th and 6th cycles, degarelix (Firmagon) will be administered on Cycle 5 day 1 and cycle 6 day 8. After cycle 6, degarelix will continue to be given every 28 days for a 5 more doses, for a total of 7 doses.

Degarelix is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Firmagon for:

• Advanced hormone-dependent prostate cancer

Approved in United States as Firmagon for:

• Advanced prostate cancer

Approved in Canada as Firmagon for:

• Hormone-sensitive prostate cancer

Approved in Japan as Firmagon for:

• Prostate cancer

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Ferring Pharmaceuticals

Industry Sponsor

Trials

323

Recruited

1,242,000+

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