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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 : Terminated
First Posted : February 18, 2016
Results First Posted : March 12, 2021
Last Update Posted : April 9, 2021
Sponsor:
Collaborators:
University of Chicago
Astellas Pharma Inc
Information provided by (Responsible Party):
Prostate Cancer Clinical Trials Consortium

Tracking Information
First Submitted Date  ICMJE February 9, 2016
First Posted Date  ICMJE February 18, 2016
Results First Submitted Date  ICMJE July 29, 2019
Results First Posted Date  ICMJE March 12, 2021
Last Update Posted Date April 9, 2021
Study Start Date  ICMJE February 2016
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2021)
Progression-free Survival (Radiographic or Per PCWG2 Criteria) [ Time Frame: 1 year ]
The primary endpoint of the study is progression-free survival (PFS), defined as the time from randomization to disease progression. Progression will be evaluated using a combination of RECIST and Prostate Cancer Working Group 2 guidelines.
Original Primary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
Progression-free survival (radiographic or per PCWG2 criteria) [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2021)
  • 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) ]
    PSA response measured according to Prostate Cancer Working Group 2 (PCWG2). The study was terminated after only 9 patients enrolled, 5 to the standard of care docetaxel/prednisone arm and 4 to experimental docetaxel/prednisone/enzalutamide arm.
  • Overall Survival [ Time Frame: At both 1 year and 2 years from treatment start ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2016)
  • 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) ]
  • Overall survival [ Time Frame: At both 1 year and 2 years from treatment start ]
Current Other Pre-specified Outcome Measures
 (submitted: March 9, 2021)
  • 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) ]
  • 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) ]
  • 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) ]
Original Other Pre-specified Outcome Measures
 (submitted: February 12, 2016)
  • 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) ]
  • 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) ]
  • 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) ]
 
Descriptive Information
Brief Title  ICMJE Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer
Official Title  ICMJE A Phase II Randomized Prospective Trial of Docetaxel/Prednisone Versus Docetaxel/Prednisone and Enzalutamide in Castration-Resistant Prostate Cancer (CRPC) Patients Progressing on Enzalutamide
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Docetaxel
  • Drug: Enzalutamide
  • Drug: Prednisone
Study Arms  ICMJE
  • Active Comparator: Docetaxel/Prednisone
    Docetaxel 75 mg/m2 day 1 (every 21-days) plus prednisone 5 mg po bid throughout
    Interventions:
    • 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.
    Interventions:
    • Drug: Docetaxel
    • Drug: Enzalutamide
    • Drug: Prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 12, 2017)
9
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2016)
100
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02685267
Other Study ID Numbers  ICMJE c13-126
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Prostate Cancer Clinical Trials Consortium
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Prostate Cancer Clinical Trials Consortium
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Chicago
  • Astellas Pharma Inc
Investigators  ICMJE Not Provided
PRS Account Prostate Cancer Clinical Trials Consortium
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP