NCT03069937

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

A Phase II Study of Docetaxel Before Medical Castration With Degarelix in Patients With Newly Diagnosed Metastatic Prostatic Adenocarcinoma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to look at patient outcomes when docetaxel is started prior to ADT with degarelix.

Detailed description

This study will look at two drugs, docetaxel and degarelix, which are both FDA approved for the treatment of prostate cancer. Docetaxel is a standard chemotherapy treatment for metastatic prostate cancer. Degarelix is an androgen deprivation therapy (ADT) agent that decreases the amount of testosterone in the body, which helps to fight tumor growth. Usually, docetaxel is given after ADT. This study will look at how your cancer changes when docetaxel is started before ADT. You are being asked to participate in this study because you have metastatic prostate cancer that can be treated with docetaxel and ADT.

Conditions

• Metastatic Prostatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Docetaxel	The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection.
DRUG	Degarelix	Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg.

Timeline

• Start date: 2017-03-01
• Primary completion: 2021-03-03
• Completion: 2024-12-11
• First posted: 2017-03-03
• Last updated: 2025-10-15
• Results posted: 2025-04-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study