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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

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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Docetaxel Drug: Prednisone Drug: Enzalutamide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CHemotherapy Plus Enzalutamide In First Line Therapy for Castration Resistant prOstate caNcer
Study Start Date : October 2014
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
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
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

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
Drug: Docetaxel
Pharmaceutical form:solution Route of administration: intravenous

Drug: Prednisone
Pharmaceutical form:tablet Route of administration: oral




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Rate of objective response according to RECIST criteria [ Time Frame: 6 months after docetaxel first administration ]
  2. Rate of biochemical response according to PCWG2 [ Time Frame: 6 months after docetaxel first administration ]
  3. Kaplan-Meier estimates of progression-free survival [ Time Frame: 6 months after docetaxel first administration ]
  4. Kaplan-Meier estimates of overall survival [ Time Frame: 6 months after docetaxel first administration ]
  5. Kaplan-Meier estimates of biochemical progression-free survival [ Time Frame: 6 months after docetaxel first administration ]
  6. Rate of treatment-related mortality [ Time Frame: 6 months after docetaxel first administration ]
  7. Rate of toxicity-related protocol withdrawal [ Time Frame: 6 months after docetaxel first administration ]
  8. Scales of brief pain inventory (BPI) [ Time Frame: 6 months after docetaxel first administration ]
  9. Analgesic score [ Time Frame: 6 months after docetaxel first administration ]
  10. Functional scales and items of FACT - P questionnaire [ Time Frame: 6 months after docetaxel first administration ]
  11. Type and grade of any adverse reaction to treatment, according to CTC-AE v. 4.03 [ Time Frame: 6 months after docetaxel first administration ]


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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:

  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.

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): NCT02453009


Contacts
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Contact: Orazio Caffo, MD +390461902478 orazio.caffo@apss.tn.it

Locations
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Italy
Santa Chiara Hospital Recruiting
Trento, Italy, 38122
Contact: Orazio Caffo, MD    +390461902478    orazio.caffo@apss.tn.it   
Sponsors and Collaborators
Santa Chiara Hospital
Investigators
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Study Chair: Orazio Caffo, MD Santa Chiara Hospital

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Responsible Party: Orazio Caffo, MD, Santa Chiara Hospital
ClinicalTrials.gov Identifier: NCT02453009     History of Changes
Other Study ID Numbers: TN-CHEIRON
First Posted: May 25, 2015    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Prednisone
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