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An Open Label Phase II Study of Biweekly Docetaxel plus Androgen-Deprivation Therapy (ADT) in Patients with Previously-Untreated, Metastatic, Prostatic Adenocarcinoma

Status Approved

  • First Submitted Date

    2018/09/04

  • Registered Date

    2019/02/22

  • Last Updated Date

    2022/03/07

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003546
    Unique Protocol ID 2017-01-005
    Public/Brief Title An Open Label Phase II Study of Biweekly Docetaxel plus Androgen-Deprivation Therapy (ADT)
    Scientific Title An Open Label Phase II Study of Biweekly Docetaxel plus Androgen-Deprivation Therapy (ADT) in Patients with Previously-Untreated, Metastatic, Prostatic Adenocarcinoma
    Acronym Docetaxel+ADT
    MFDS Regulated Study Yes
    IND/IDE Protocol No
    Registered at Other Registry Yes
    Name of Registry / Registration Number ClinicalTrials.gov-NCT03061643
    Healthcare Benefit Approval Status Submitted approval
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number SMC2017-01-005-006
    Approval Date 2018-02-13
    Institutional Review Board Name Institutional Review Board
    Institutional Review Board Address 81, Irwon-ro, Gangnam-gu, Seoul
    Institutional Review Board Telephone 02-3410-2973
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Park Se Hoon
    Title PI
    Telephone +82-2-3410-3459
    Affiliation Samsung Medical Center
    Address 81 Irwon-Ro, Gangnam-Gu, Seoul
    Contact Person for Public Queries
    Name Park Se Hoon
    Title PI
    Telephone +82-2-3410-3459
    Affiliation Samsung Medical Center
    Address 81 Irwon-Ro, Gangnam-Gu, Seoul
    Contact Person for Updating Information
    Name Park Se Hoon
    Title PI
    Telephone +82-2-3410-3459
    Affiliation Samsung Medical Center
    Address 81 Irwon-Ro, Gangnam-Gu, Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2018-08-10 Actual
    Target Number of Participant 51
    Primary Completion Date 2020-12-23 , Actual
    Study Completion Date 2020-12-23 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Samsung Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2018-08-10 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Sanofi-Aventis Korea
    Organization Type Pharmaceutical Company
    Project ID SMC 2017-01-005
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Samsung Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Study Rationale
    Although surgical or medical castration is considered standard treatment in hormone-naïve PC patients, some patients with extensive metastatic disease, including visceral or bone involvement beyond axial skeleton, have shorter survival. Based on the recent randomized trials (CHAARTED, GETUG-AFU15 and STAMPEDE), hormone-naïve men with metastatic, high-volume PC should be offered docetaxel plus ADT. However, side effects from standard 3-weekly 75 mg/m2 docetaxel can be substantial. In addition, a prospective trial is needed to determine whether early docetaxel chemotherapy in combination with ADT is beneficial in Korean men. Considering our own experiences with docetaxel, a dose intensity of 20 mg/m2/week (equivalent to 60 mg/m2 3-weekly or 40 mg/m2 biweekly) should be tested in the prospective trial.
    
    Objectives
    This is a single-center, prospective, open-label, non-randomized phase II trial to evaluate the efficacy and safety of docetaxel administered biweekly concurrently with ADT in patients with previously-untreated, metastatic PC. The main objectives of this study are,
    -	Primary objective: to determine the antitumor activity of study treatment in terms of time-to-CRPC 
    -	Secondary objectives:
    1.	to determine the antitumor activity of study treatment in terms of PSA response, progression-free survival (PFS) and overall survival (OS)
    2.	to determine safety and tolerability of study treatment in patients with previously-untreated, metastatic PC
    3.	to identify markers potentially related to docetaxel activity in patients with previously-untreated, metastatic PC
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Phase2
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation Not Applicable
    Intervention Type Drug  
    Intervention Description
    Patients will receive docetaxel 40 mg/m2 IV every 2 weeks plus ADT. Docetaxel was repeated on an outpatient basis and continued until disease progression, unacceptable toxicity, deterioration of clinical condition, patient refusal, or up to 12 months. ADT includes commercially available GNRH agonists such as goserelin, leuprolide and triptorelin, according to their market authorized approved label.
    Number of Arms 1
    Arm 1

    Arm Label

    docetaxel+ADT

    Target Number of Participant

    51

    Arm Type

    Experimental

    Arm Description

    Patients will receive docetaxel 40 mg/m2 IV every 2 weeks plus ADT. Docetaxel was repeated on an outpatient basis and continued until disease progression, unacceptable toxicity, deterioration of clinical condition, patient refusal, or up to 12 months. ADT includes commercially available GNRH agonists such as goserelin, leuprolide and triptorelin, according to their market authorized approved label.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (C00-D48)Neoplasms 
       (C61)Malignant neoplasm of prostate 

    CRPC: Castration-resistant prostate cancer
    Rare Disease No
    Inclusion Criteria

    Gender

    Male

    Age

    20Year~No Limit

    Description

    For inclusion of a subject in the study, all of the following inclusion criteria must be fulfilled:
    1.	Subject is a male at least 20 years of age.
    2.	Subject has a histologically or cytologically confirmed diagnosis of adenocarcinoma of prostate.
    3.	Subject has radiologic and clinical evidence of metastatic disease initially or after treatment for localized disease. They must have metastatic or progressive disease for which there is no further curative treatment available.
    4.	Subject has an ECOG performance status of 0 to 1. 
    5.	Subject has a life expectancy of 3 months or more.
    6.	At least 4 weeks since the last surgical procedures or radiotherapy prior to enrolment. Subjects must have recovered to <Grade 2 from all acute toxicities or toxicity must be deemed irreversible by the investigator.
    7.	Acceptable hematologic status (without growth factor support or transfusion dependency):
    a.	ANC  1500 cells/μL.
    b.	Platelet count  100,000/μL.
    c.	Hemoglobin  9.0 g/dL.
    8.	Acceptable renal function with serum creatinine  1.5 x ULN or a calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault or MDRD formulas.
    9.	Acceptable liver function: 
    a.	Bilirubin  1.5 times upper limit of normal (x ULN); does not apply to subjects with Gilbert’s syndrome diagnosed as per institutional guidelines.
    b.	AST (SGOT) and ALT (SGPT)  3 x ULN; if liver metastases are present, then  5 x ULN is allowed.
    10.	Subject must agree to use an adequate method of contraception (condom) if he is having sex with a woman of childbearing potential or with a woman who is pregnant.
    11.	Written and voluntary informed consent understood, signed and dated.
    Exclusion Criteria
    For inclusion of a subject in the study, any of the following inclusion criteria must not be fulfilled:
    1.	Ongoing treatment with an anticancer agent not contemplated in this protocol
    2.	Pathologic finding consistent with neuroendocrine or small cell carcinoma
    3.	Any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years, New York Heart Association (NYHA) grade III or greater congestive heart failure, cerebrovascular attack within the prior year, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
    4.	Non-tolerable >Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1
    5.	Known uncontrolled brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 4 weeks prior to Cycle 1 Day 1). Subjects that develop brain metastasis during the study may have their treatment interrupted to receive a course of cranial radiation and restart trial medication after a recovery period of at least 1 week. High dose corticosteroids may be employed for the management of cranial radiation but must be tapered off before resuming treatment.
    6.	Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery. 
    7.	Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
    8.	Subjects who have exhibited allergic reactions to taxanes.
    9.	Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study. 
    10.	The subject has legal incapacity or limited legal capacity. Dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol. Unwillingness or inability to comply with the study protocol for any reason.
    11) All corticosteroids are forbidden
    12) Those who showed hypersensitivity to acetic acid goserelin and LHRH-like drugs
    13) Those diagnosed with hormone-independent prostate cancer
    14) Those diagnosed with pituitary adenoma
    15) After receiving both testicular resections, those who can no longer expect reduction of testosterone by this drug
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Radiological and/or physical assessments of the tumor lesions
    Timepoint
    at screening (4 weeks before the first study drug administration), at the end of cycle 4 and at approximately 8 week intervals thereafter until disease progression
    Secondary Outcome(s) 1
    Outcome
    Safety evaluation
    Timepoint
    all adverse events (AEs) observed or reported by the patient during the study regardless of the relationship to study medication and/or clinical significance
    Secondary Outcome(s) 2
    Outcome
    Prostate - specific antigen
    Timepoint
    per 4 weeks
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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