Docetaxel + Degarelix for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Medical University of South Carolina

No Placebo Group

Prior Safety Data

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.

Patients must have at least one of the following at time of study enrollment: Any visceral metastases identified by CT scans or MRI, Site(s) of bony metastasis identified by nuclear bone scan, MRI, and/or CT scan, Lymph node based disease not considered to be within a single radiation therapy port, Non-castrate testosterone level >50 ng/dl, Age greater than or equal to 18 years, ECOG performance status 0-2

My prostate cancer is confirmed by lab tests.

+4 more

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.

+10 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: Docetaxel + DegarelixExperimental Treatment2 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: