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A Trial of Androgen Deprivation, Docetaxel, and Enzalutamide for Metastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03246347
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : May 17, 2021
Astellas Pharma Inc
Medivation, Inc.
Information provided by (Responsible Party):
Earle Burgess, MD, Atrium Health

Brief Summary:
This is a study with the combination of androgen deprivation therapy (ADT) and docetaxel with the addition of enzalutamide in the treatment of subjects with metastatic prostate cancer. The purpose of this study is to assess if ADT + docetaxel + enzalutamide is well tolerated and demonstrates improved efficacy compared to ADT + docetaxel.

Condition or disease Intervention/treatment Phase
Prostate Cancer Prostate Adenocarcinoma Drug: ADT+Docetaxel+Enzalutamide Phase 2

Detailed Description:
This is a single center, single arm, phase II trial designed to evaluate the 12 month PSA complete response rate in patients with metastatic hormone sensitive prostate cancer treated with ADT, docetaxel and enzalutamide. The primary endpoint of this study will be 12-month PSA complete response rate, which will be assessed against a contemporary historical control rate for the combination of ADT and docetaxel alone in the metastatic hormone naive setting. The study will be conducted at all participating sites across North and South Carolina within the Levine Cancer Institute network. Enrollment is anticipated to be completed within 24 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Androgen Deprivation, Docetaxel and Enzalutamide in Patients With Metastatic Hormone Sensitive Prostate Cancer
Actual Study Start Date : August 21, 2017
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : March 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Single Arm
Docetaxel + Enzalutamide + Androgen Deprivation Therapy
Drug: ADT+Docetaxel+Enzalutamide
combination therapy as listed above
Other Names:
  • Taxotere
  • Xtandi

Primary Outcome Measures :
  1. PSA complete response rate [ Time Frame: 12 month ]

Secondary Outcome Measures :
  1. Serologic response rate [ Time Frame: Duration of study participation, an average of 2 years ]
  2. Radiographic response rate [ Time Frame: Duration of study participation, an average of 2-3 years ]
  3. Time to castrate resistance [ Time Frame: Duration of study participation, an average of 2 years ]
  4. serologic progression free survival [ Time Frame: Duration of study participation, an average of 2 years ]
  5. radiographic progression free survival [ Time Frame: Duration of study participation, an average of 2-3 years ]
  6. overall survival [ Time Frame: Duration of study participation, an average of 5 years ]
  7. time to treatment failure [ Time Frame: Duration of study participation, an average of 2-3 years ]
  8. Treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Duration of study participation, an average of 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without evidence of small cell carcinoma or greater than 50% neuroendocrine differentiation. Metastatic disease must be present including soft tissue, and/or bone metastases OR nonregional lymph node involvement prior to study enrollment. If the subject has regional lymph node involvement, there must be at least one additional site of disease including visceral, non-regional nodal or skeletal metastases.
  • ADT with surgical castration with bilateral orchiectomy or medical castration with LHRH agonist or LHRH antagonist therapy may have been initiated no greater than 112 days (16 weeks) prior to enrollment date. Subjects who initiated ADT prior to consent, are not eligible if PSA has risen ≥ 25% and ≥ 2 ng/ml above nadir value since initiation of ADT prior to consent.
  • At least one PSA level of ≥ 5 ng/ml within 90 days prior to consent.
  • Prior ADT for non-metastatic disease with LHRH agonist or LHRH antagonist therapy in the neoadjuvant/adjuvant setting is permitted if:

    1. Total duration of therapy did not exceed 36 months
    2. 6 months have elapsed since completion of therapy prior to consent,
    3. Serum testosterone > 50 ng/dl within 28 days prior to reinitiation of ADT for metastatic disease
    4. Prior ADT for non-metastatic disease must have accompanied definitive local therapy for curative intent.
  • Age ≥ 18 years.
  • ECOG performance status 0-2.
  • Adequate liver function: AST and ALT <1.5x upper limit of normal, total bilirubin < 1x upper limit of normal.
  • Adequate bone marrow function: Platelets >100,000 cells/mm3, Hemoglobin > 8.0g/dL and ANC > 1,500 cells/mm3.
  • Adequate renal function with a creatinine clearance (based on Cockcroft-Gault formula) ≥ 30 mL/min.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Able to swallow and retain oral medication

Exclusion Criteria:

  • Personal history of seizure.
  • Personal history of conditions that may predispose to seizure activity including cortical cerebrovascular accident or brain trauma.
  • Known central nervous system metastases, including involvement of brain parenchyma and leptomeninges.
  • Personal history of any condition that may impair absorption of enzalutamide.
  • Prior or current therapy with ketoconazole, abiraterone, enzalutamide, apalutamide (ARN-509, JNJ-56021927), darolutamide (ODM-201, BAY1841788) or cytotoxic chemotherapy such as docetaxel, cabazitaxel, cyclophosphamide.
  • Prior therapy with bicalutamide, nilutamide or flutamide within 14 days of enrollment.
  • Within 28 days of major surgery and/or lack of recovery from prior surgical procedure or 14 days of palliative radiation prior to enrollment.
  • Prior or current therapy with an investigational agent for metastatic prostate cancer.
  • Known hypersensitivity to drugs formulated with polysorbate 80.
  • Personal history of posterior reversible encephalopathy syndrome.
  • CTCAE version 4.0 grade 2-4 peripheral sensory neuropathy.
  • Human immunodeficiency virus infection or active hepatitis B or C infection.
  • Uncontrolled and current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator.
  • Presence of any of the following within the previous 3 months prior to enrollment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, or cerebrovascular accident including transient ischemic attack.
  • History of an additional active malignancy within 12 months prior to the date of consent (except non-melanoma skin cancer).
  • Current use of strong CYP2C8 inhibitors, CYP3A4 inducers or CYP3A4, CYP2C9 or CYP2C19 substrates with a narrow therapeutic range as listed in Section 7.2.1.
  • Any condition that requires the use of prednisone > 10mg daily, or equivalent daily glucocorticoid dose, for greater than 14 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03246347

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Contact: Sandra Samu-Arce, RN 980-993-5484

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United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Sandra Samu-Arce, RN    980-993-5484   
Sponsors and Collaborators
Earle Burgess, MD
Astellas Pharma Inc
Medivation, Inc.
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Principal Investigator: Earle Burgess, MD Atrium Health (formerly Carolinas HealthCare System)
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Responsible Party: Earle Burgess, MD, Earle Burgess MD, Atrium Health Identifier: NCT03246347    
Other Study ID Numbers: LCI-GU-PRO-ADDE-001
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action