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Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer (Doce/Enza)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02685267
Recruitment Status : Unknown
Verified July 2018 by Prostate Cancer Clinical Trials Consortium.
Recruitment status was:  Active, not recruiting
First Posted : February 18, 2016
Last Update Posted : July 16, 2018
Sponsor:
Collaborators:
University of Chicago
Astellas Pharma Inc
Information provided by (Responsible Party):
Prostate Cancer Clinical Trials Consortium

Brief Summary:

This is a prospective randomized phase II clinical trial where patients who are receiving enzalutamide in the pre-chemotherapy space are randomized upon objective progression (radiographic and/or clinical per PCWG2 criteria) to docetaxel/prednisone alone or the same combination plus enzalutamide.

The primary aim is to evaluate whether continuing enzalutamide in combination with docetaxel in patients who failed or progressed while on enzalutamide would increase progression-free survival (PFS) by 4 months. The secondary end points are PSA responses, percent of patients alive at 1 and 2 years, decline in circulating tumor cells (CTCs), and quality of life (QOL) using validated scales.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Docetaxel Drug: Enzalutamide Drug: Prednisone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Randomized Prospective Trial of Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer (CRPC) Patients Progressing on Enzalutamide
Study Start Date : February 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Docetaxel/Prednisone
Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout
Drug: Docetaxel
Drug: Prednisone
Active Comparator: Docetaxel/Prednisone + Enzalutamide
Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout plus Enzalutamide 160 mg daily throughout. Subjects will continue enzalutamide until PD after 10 cycles of docetaxel.
Drug: Docetaxel
Drug: Enzalutamide
Drug: Prednisone



Primary Outcome Measures :
  1. Progression-free survival (radiographic or per PCWG2 criteria) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. PSA response in the standard treatment arm and experimental treatment arm [ Time Frame: Baseline, Day 84 (C4D1), Day 147 (C7D1), Day 210 (C10D1), Day 231, and every 21 days through study completion (an average of 1 year) ]
  2. Overall survival [ Time Frame: At both 1 year and 2 years from treatment start ]

Other Outcome Measures:
  1. Quality of life (QOL) [ Time Frame: Baseline, Day 84 (C4D1), Day 147 (C7D1), Day 210 (C10D1), Day 231 and every 21 days through study completion (an average of 1 year) ]
  2. Circulating Tumor Cells (CTCs) [ Time Frame: Baseline, Day 84 (C4D1), Day 147 (C7D1), Day 210 (C10D1), and every 63 days through study completion (an average of 1 year) ]
  3. Analysis of androgen receptor splice variant [ Time Frame: Baseline, Day 84 (C4D1), Day 147 (C7D1), Day 210 (C10D1), and every 63 days through study completion (an average of 1 year) ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information.

NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.

  • Males 18 years of age and above
  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
  • Having documented disease progression on enzalutamide defined by 1 or more of the following criteria:
  • PSA progression according to PCWG2 criteria with 3 consecutive rising PSA measurements, all collected at least 1 week apart
  • Radiographic progression in soft tissue or bone by modified RECIST 1.1 for subjects with measurable disease; or
  • Bone disease progression defined by 2 or more new lesions on 2 consecutive bone scans in the absence of falling PSA
  • Patients who have not had a bilateral orchiectomy must have a plan to maintain effective GnRG-analogue therapy for the duration of the trial
  • Serum testosterone level < 50 ng/dL at Screening visit
  • ECOG PS: 0-1
  • Throughout the study, male patients and their female partners of childbearing potential must use 2 acceptable methods of birth control (1 of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration. Two acceptable methods of birth control thus include the following:
  • Condom (barrier method of contraception even if having sex with a pregnant woman)
  • One of the following is required:

    • Established use of oral, injected, or implanted hormonal method of contraception by the female partner
    • Placement of an intrauterine device (IUD) or intrauterine system (IUS) by the female partner
    • Additional barrier method: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository by the female partner
    • Tubal litigation in the female partner
    • Vasectomy or other procedure resulting in infertility (eg, bilateral orchiectomy) for >6 months
  • Patients must have adequate organ and marrow function as defined below
  • Leukocytes >3,000/mm3
  • absolute neutrophil count >1,500/mm3
  • platelets >100,000/mm3
  • total bilirubin within normal institutional limits (or <2X the upper limit of normal in those with Gilbert's disease)
  • AST(SGOT)/ALT(SGPT) <1.5 X institutional upper limit of normal
  • creatinine within normal institutional limits OR
  • creatinine clearance* >45 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
  • Estimated life expectancy of > 6 months
  • Able to swallow the study drug as prescribed and comply with study requirements

Exclusion Criteria:

  • Prior treatment with docetaxel-based chemotherapy
  • Prior treatment with abiraterone acetate
  • Prior treatment with cabazitaxel
  • Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
  • Ongoing investigational treatment
  • Medical conditions such as uncontrolled hypertension, uncontrolled diabetes mellitus, cardiac disease that would, in the opinion of the investigator, make this protocol unreasonably hazardous
  • Major surgery within 4 weeks of enrollment
  • Use of an investigational therapeutic agent with 4 weeks of enrollment
  • History of seizure or any condition that may predispose to seizure.
  • History of loss of consciousness or transient ischemic attack within 12 months of enrollment
  • Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease) within last 3 months
  • Grade > 2 treatment-related toxicity from prior therapy
  • History of hypersensitivity to polysorbate 80
  • Any known allergy to the compounds under investigation
  • Any other condition which, in the opinion of the Investigator, would preclude participation in this trial

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 ClinicalTrials.gov identifier (NCT number): NCT02685267


Locations
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United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
NorthShore University HealthSytem - Kellogg Cancer Center
Evanston, Illinois, United States, 60201
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
United States, Wisconsin
Univesity of Wisconsin
Madison, Wisconsin, United States, 53705
Sponsors and Collaborators
Prostate Cancer Clinical Trials Consortium
University of Chicago
Astellas Pharma Inc
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Responsible Party: Prostate Cancer Clinical Trials Consortium
ClinicalTrials.gov Identifier: NCT02685267    
Other Study ID Numbers: c13-126
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Prednisone
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal