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Hormone Therapy

Docetaxel + Degarelix for Prostate Cancer

Phase 2

Waitlist Available

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have adequate end-organ function as defined by specific parameters

Histological or cytological diagnosis of adenocarcinoma of the prostate

Must not have

More than 30 days of anti-androgen in the metastatic setting prior to the start of study treatment

Prior malignancy requiring systemic therapy within the last 5 years except for treated basal or squamous cell skin cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 34 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate the effects of adding the cancer drug docetaxel to the care of men with metastatic prostate cancer who are also receiving the hormone therapy drug degarelix.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Docetaxel can cause side effects like low blood cell counts leading to increased infection risk, fatigue, hair loss, nail changes, nerve damage (neuropathy), and allergic reactions. Degarelix may lead to injection site pain or reaction, hot flashes, weight gain and increase cholesterol levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My vital organs are functioning well.

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My prostate cancer is confirmed by lab tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have had hormone or chemotherapy for prostate cancer after it spread.

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I have been treated with docetaxel for metastatic prostate cancer.

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I do not have any active heart conditions.

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I have mild to severe nerve damage.

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My cancer has spread to my brain or its coverings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 34 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~34 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 34 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PSA response at 10 months

Secondary study objectives

Development of castration resistance after initiation with ADT

Frequency of adverse events (AEs) using CTCAE v. 4

Frequency of disease progression at 12 weeks using PSA

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Docetaxel

1995

Completed Phase 4

~6550

Degarelix

2002

Completed Phase 3

~3730