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

NCT ID: NCT03069937

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2024-12-11

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetaxel + Degarelix

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.

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection.

Degarelix

Intervention Type: DRUG

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.

Interventions

Docetaxel

The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

taxotere; Firmagon

Eligibility Criteria

Inclusion Criteria

1. Histological or cytological diagnosis of adenocarcinoma of the prostate.

2. Metastatic disease identified via radiographic assessment by CT scans of the chest, abdomen, pelvis, and nuclear bone scan. MRI may be used if deemed necessary by the investigator. See Section 8.5 for more details about radiographic assessment requirements.

More specifically, patients must have at least one of the following at time of study enrollment:

1. Any visceral metastases identified by CT scans or MRI.

2. Site(s) of bony metastasis identified by nuclear bone scan, MRI, and/or CT scan.

3. Lymph node based disease not considered to be within a single radiation therapy port (e.g. at or above the aortic bifurcation.)

3. Non-castrate testosterone level, >50 ng/dl, at study enrollment.

4. Age greater than or equal to 18 years.

5. ECOG performance status 0-2.

6. Meet the following hematologic criteria within 14 days of enrollment to trial:

1. Absolute neutrophil count > 1,500/mm3

2. Hemoglobin > 8.0 g/dl (may be transfused)

3. Platelet count > 100,000 mm3

7. Have adequate end-organ function as defined by the following parameters. All lab values must be obtained within 14 days of enrollment to trial:

1. Creatinine clearance of > 30 ml/min. Creatinine clearance should be determined by the Cockcroft-Gault formula (Appendix A)

2. AST < 2 x institutional ULN

3. ALT < 2 x institutional ULN

4. Total bilirubin < institutional ULN

8. Agree to use barrier methods of birth control during the docetaxel portion of the protocol and for at least one month after last docetaxel administration.

9. Informed and must sign and give written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria

Patients eligible for study participation CANNOT meet any of the following criteria:

1. CNS metastases (brain or leptomeningeal).

2. Osseous metastases felt in the opinion of the clinician to be high-risk for impending pathologic fracture or spinal cord compression.

3. Active cardiac disease defined as symptomatic congestive heart failure, history of NYHA Class III or IV Heart Failure, uncontrollable supraventricular arrhythmias, any history of a ventricular arrhythmia, active angina pectoris, myocardial infarction or coronary intervention within 6 months of registration.

4. Prior malignancy requiring systemic therapy within the last 5 years except for treated basal or squamous cell skin cancer. History of low-grade malignancies with limited potential to progress as determined by the primary investigator may be enrolled.

5. Subjects must not have received any previous androgen deprivation therapy (LHRH agonist or LHRH antagonist) or cytotoxic therapy for prostate cancer in the metastatic setting.

Exception Patients may have received no more than 30 days of anti-androgen (e.g. bicalutamide) in the metastatic setting prior to the start of study treatment.

6. Subjects must not have had more than 36 months of hormonal therapy in combination with prostatectomy or radiation in the setting of localized disease and must not have shown any evidence of disease recurrence within 12 months after stopping hormonal therapy. Disease recurrence after hormonal therapy is defined as PSA > 0.2ng/dl after prostatectomy + hormonal therapy or PSA that is 2.0ng/dl more than the PSA nadir after radiotherapy + hormonal therapy. Previous hormonal therapy to the prostate must have stopped at least 12 months prior to enrollment.

7. Subjects must not have been treated with prior docetaxel in the setting of metastatic prostate cancer. Subjects may have been treated with docetaxel in the setting of localized prostate cancer (likely as a trial-based neoadjuvant or adjuvant approach to prostatectomy or radiation.) Subjects treated with this approach must not have shown any evidence of disease recurrence within 12 months after stopping docetaxel. Disease recurrence after docetaxel is defined as PSA > 0.2ng/dl after prostatectomy + docetaxel or PSA that is 2.0ng/dl more than the PSA nadir after radiotherapy +docetaxel. Previous docetaxel in the setting of localized prostate cancer must have stopped at least 12 months prior to study enrollment.

8. Palliative radiation therapy may have been received but not within the 30 days prior to study treatment.

9. Presence of peripheral neuropathy > Grade 1.

10. Known HIV-positive

11. Presence of any severe or uncontrolled concurrent medical condition felt in the opinion of the investigator to increase the risk of serious toxicity from the study therapy.

12. Prior hypersensitivity to any of the components of the study drugs.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00061532

Identifier Type: OTHER

Identifier Source: secondary_id

102509

Identifier Type: -

Identifier Source: org_study_id