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

NCT03069937 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 102509Pro00061532
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Prostatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• PSA Response at 10 Months

  PSA complete response is defined as PSA level less than or equal to 0.2 ng/ml for two consecutive measurements at least three weeks apart. Date of complete response will be defined as the date of first recorded value less than 0.2 ng/ml. PSA progression will be defined as \> 25% increase from the PSA nadir (lowest PSA value recorded since trial enrollment) and \> 2 ng/dl above the nadir. Two consecutive increases must be recorded at least three weeks apart. Date of PSA progression will be defined as the first recorded PSA value that is a \> 25% increase from the PSA nadir and \> 2 ng/dl above the nadir.

  10 months

Secondary Outcomes (7)

• PSA Response at 6 Months

  6 months

• Number of Grade 3 and 4 Adverse Events Related to Docetaxel During First 4 Cycles

  Up to 12 weeks (first 4 cycles of docetaxel)

• Frequency of Disease Progression at 12 Weeks Using PSA

  12 weeks

• PSA Response at 12 Weeks

  12 weeks

• Time to Development of Castration Resistance After Initiation With ADT

  From initiation of Degarelix until disease progression or end of follow-up (up to 34 months)

Study Arms (1)

Docetaxel + Degarelix

EXPERIMENTAL

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.

Drug: Docetaxel; Drug: Degarelix

Interventions

Docetaxel DRUG

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

Also known as: taxotere

Docetaxel + Degarelix

Degarelix 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.

Also known as: Firmagon

Docetaxel + Degarelix

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological or cytological diagnosis of adenocarcinoma of the prostate.
• 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:
• 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 (e.g. at or above the aortic bifurcation.)
• Non-castrate testosterone level, \>50 ng/dl, at study enrollment.
• Age greater than or equal to 18 years.
• ECOG performance status 0-2.
• Meet the following hematologic criteria within 14 days of enrollment to trial:
• Absolute neutrophil count \> 1,500/mm3
• Hemoglobin \> 8.0 g/dl (may be transfused)
• Platelet count \> 100,000 mm3
• Have adequate end-organ function as defined by the following parameters. All lab values must be obtained within 14 days of enrollment to trial:
• Creatinine clearance of \> 30 ml/min. Creatinine clearance should be determined by the Cockcroft-Gault formula (Appendix A)

You may not qualify if:

• Patients eligible for study participation CANNOT meet any of the following criteria:
• CNS metastases (brain or leptomeningeal).
• Osseous metastases felt in the opinion of the clinician to be high-risk for impending pathologic fracture or spinal cord compression.
• 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.
• 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.
• 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.
• 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.
• 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.
• Palliative radiation therapy may have been received but not within the 30 days prior to study treatment.
• Presence of peripheral neuropathy \> Grade 1.
• Known HIV-positive
• 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.
• Prior hypersensitivity to any of the components of the study drugs.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Interventions

Docetaxel; acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Principal Investigator
• Organization: Medical University of South Carolina

gourdith@musc.edu

843-792-4271

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 3, 2017
• Study Start: March 1, 2017
• Primary Completion: March 3, 2021
• Study Completion: December 11, 2024
• Last Updated: October 15, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)