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Addition of Enzalutamide to First Line Docetaxel for Castration Resistant Prostate Cancer (CHEIRON)

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ClinicalTrials.gov Identifier: NCT02453009
Recruitment Status : Unknown
Verified May 2015 by Orazio Caffo, Santa Chiara Hospital.
Recruitment status was:  Recruiting
First Posted : May 25, 2015
Last Update Posted : May 25, 2015
Sponsor:
Information provided by (Responsible Party):
Orazio Caffo, Santa Chiara Hospital

Tracking Information
First Submitted Date  ICMJE May 19, 2015
First Posted Date  ICMJE May 25, 2015
Last Update Posted Date May 25, 2015
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2015)
Rate of patients without progression (according to guideline of Prostate Cancer Clinical Trials Working Group 2 - PCWG2) [ Time Frame: 6 months after docetaxel first administration ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2015)
  • Rate of objective response according to RECIST criteria [ Time Frame: 6 months after docetaxel first administration ]
  • Rate of biochemical response according to PCWG2 [ Time Frame: 6 months after docetaxel first administration ]
  • Kaplan-Meier estimates of progression-free survival [ Time Frame: 6 months after docetaxel first administration ]
  • Kaplan-Meier estimates of overall survival [ Time Frame: 6 months after docetaxel first administration ]
  • Kaplan-Meier estimates of biochemical progression-free survival [ Time Frame: 6 months after docetaxel first administration ]
  • Rate of treatment-related mortality [ Time Frame: 6 months after docetaxel first administration ]
  • Rate of toxicity-related protocol withdrawal [ Time Frame: 6 months after docetaxel first administration ]
  • Scales of brief pain inventory (BPI) [ Time Frame: 6 months after docetaxel first administration ]
  • Analgesic score [ Time Frame: 6 months after docetaxel first administration ]
  • Functional scales and items of FACT - P questionnaire [ Time Frame: 6 months after docetaxel first administration ]
  • Type and grade of any adverse reaction to treatment, according to CTC-AE v. 4.03 [ Time Frame: 6 months after docetaxel first administration ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Addition of Enzalutamide to First Line Docetaxel for Castration Resistant Prostate Cancer
Official Title  ICMJE CHemotherapy Plus Enzalutamide In First Line Therapy for Castration Resistant prOstate caNcer
Brief Summary The aim of this study is to verify if the addition of enzalutamide to docetaxel is able to improve the disease control in first line CRPC patients.
Detailed Description CHEIRON trial is a phase II randomized study comparing docetaxel plus enzalutamide to docetaxel alone as first line for castration resistant prostate cancer.
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 Prostatic Neoplasms
Intervention  ICMJE
  • Drug: Docetaxel
    Pharmaceutical form:solution Route of administration: intravenous
  • Drug: Prednisone
    Pharmaceutical form:tablet Route of administration: oral
  • Drug: Enzalutamide
    Pharmaceutical form : soft gelatin capsules Route of administration: oral
    Other Name: Xtandi
Study Arms  ICMJE
  • Experimental: Arm A
    Docetaxel 75 mg/m² intravenously on day 1 every 3 weeks for 8 cycles, plus oral prednisone 10 mg daily for 24 weeks plus oral enzalutamide 160 mg daily for 24 weeks
    Interventions:
    • Drug: Docetaxel
    • Drug: Prednisone
    • Drug: Enzalutamide
  • Active Comparator: Arm B
    Docetaxel 75 mg/m² intravenously on day 1 every 3 weeks for 8 cycles, plus oral prednisone 10 mg daily for 24 weeks
    Interventions:
    • Drug: Docetaxel
    • 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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 22, 2015)
232
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically- or cytologically-confirmed prostate adenocarcinoma.
  2. Metastatic disease.
  3. Progressive disease while receiving hormonal therapy or after surgical castration documented by at least one of the following:

    • Increase in measurable disease (RECIST 1.1) [15], and/or
    • Appearance of new lesions, including those on bone scan consistent with progressive prostate cancer, and/or
    • Rising PSA defined as 2 sequential increases above a previous lowest reference value. Each value must be obtained at least 1 week apart. A PSA value of at least 2 ng/ml is required at study entry.
    • Effective castration (serum testosterone levels ≤0.50 ng/dL) by orchiectomy and/or LHRH agonists or antagonist with or without anti-androgens.

      i. If the patient has been treated with LHRH agonists or antagonist (i.e., without orchiectomy), then this therapy should be continued.

    ii. If patients were either started on complete androgen blockade, or had a PSA response (defined by any reduction in PSA sustained for at least 3 months) after adding an antiandrogen, prior anti-androgen therapy should be stopped before randomization: at least 6 weeks for bicalutamide and nilutamide, and at least 4 weeks for flutamide, megestrol acetate and any other hormonal therapy.

  4. More than 18 years.
  5. Eastern Cooperative Oncology Group (ECOG) performance status <2 (see Appendix 2).
  6. Ability to fill the quality of life questionnaire
  7. Patient compliance and geographic proximity that allow adequate follow-up.
  8. Presence of signed and dated IRB-approved patient informed consent form prior to enrollment into the study.

Exclusion Criteria:

  1. Prior chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed >3 years ago.
  2. Prior treatment with abiraterone acetate and/or enzalutamide
  3. Less than 28 days elapsed from prior treatment with estramustine, radiotherapy or surgery to the time of randomization. Patients may be on biphosphonates prior to study entry.
  4. Prior isotope therapy, whole pelvic radiotherapy, or radiotherapy to >30% of bone marrow.
  5. History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis or new evidence of brain or leptomeningeal disease.
  6. History of seizure or any condition that may predispose to seizure (eg, prior cortical stroke or significant brain trauma). History of loss of consciousness or transient ischemic attack within 12 months of randomization;
  7. Inadequate organ and bone marrow function
  8. Contraindications to the use of corticosteroid treatment.
  9. Clinically significant cardiovascular disease
  10. Any of the following within 3 months prior to randomization: treatment resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
  11. Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
  12. Prior malignancy. Adequately treated basal cell or squamous cell skin or superficial (pTis, pTa, and pT1) bladder cancer are allowed, as well as any other cancer for which chemotherapy has been completed >5 years ago and from which the patient has been disease-free for >5 years.
  13. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.
  14. Any other condition which in the judgment of the investigator would place the subject at undue risk or interfere with the study.
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 Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02453009
Other Study ID Numbers  ICMJE TN-CHEIRON
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Orazio Caffo, Santa Chiara Hospital
Study Sponsor  ICMJE Santa Chiara Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Orazio Caffo, MD Santa Chiara Hospital
PRS Account Santa Chiara Hospital
Verification Date May 2015

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