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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 34 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My vital organs are functioning well.

Select...

My prostate cancer is confirmed by lab tests.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PSA response at 10 months

Secondary outcome measures

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

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

~5620

Degarelix

2002

Completed Phase 3

~3600

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

932 Previous Clinical Trials

7,394,208 Total Patients Enrolled

19 Trials studying Prostate Cancer

779 Patients Enrolled for Prostate Cancer

Ferring PharmaceuticalsIndustry Sponsor

313 Previous Clinical Trials

440,806 Total Patients Enrolled

52 Trials studying Prostate Cancer

17,867 Patients Enrolled for Prostate Cancer

Media Library

Degarelix (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03069937 — Phase 2

Prostate Cancer Research Study Groups: Docetaxel + Degarelix

Prostate Cancer Clinical Trial 2023: Degarelix Highlights & Side Effects. Trial Name: NCT03069937 — Phase 2

Degarelix (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03069937 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Docetaxel previously been the subject of other clinical research?

"Currently, Docetaxel is being studied in 346 active trials with 132 of them reaching Phase 3. Most studies are concentrated around São Paulo and RS; however, there are 23512 locations across which the clinical trial for this drug has been deployed."

Answered by AI

What ailments is Docetaxel commonly prescribed to address?

"Docetaxel is a pharmaceutical used to treat cancers like advanced directives, sarcoma and esophageal neoplasms malignant. It can also be prescribed when treating malignant neoplasms."

Answered by AI

Are there still vacancies available on this trial for participants?

"Unfortunately, no more patients can join this research trial. The original post was published on March 1st of 2017 and the most recent update occured August 9th 2022. Fortunately, there are still 1969 study openings for those with adenocarcinoma and 346 trials utilising Docetaxel that need participants."

Answered by AI

Does Docetaxel pose a significant risk of harm to the people taking it?

"Our research team at Power rated Docetaxel's safety with a 2, as there is some existing evidence of its security but no data to back up its efficacy."

Answered by AI

How many participants are currently being enrolled in this research project?

"Recruitment for this trial has ended. It was first listed on March 1st, 2017 and the latest update occurred August 9th, 2022. Currently 1969 studies related to adenocarcinoma and 346 studies using Docetaxel are actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Study of Docetaxel Before Degarelix in Patients With Newly Diagnosed Metastatic Prostate Cancer.

2017. "Phase II Study of Docetaxel Before Degarelix in Patients With Newly Diagnosed Metastatic Prostate Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03069937.

All > Adenocarcinoma > Metastatic Prostate Cancer