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
CRIS Registration Number |
KCT0003546 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | Sanofi-Aventis Korea |
Organization Type | Pharmaceutical Company |
Project ID | SMC 2017-01-005 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Samsung Medical Center |
Organization Type | Medical Institute |
7. Study Summary
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 |
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8. Study Design
Study Type | Interventional Study |
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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 |
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Arm Type Experimental |
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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
Condition(s)/Problem(s) |
* (C00-D48)Neoplasms (C61)Malignant neoplasm of prostate CRPC: Castration-resistant prostate cancer |
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Rare Disease | No |
Inclusion Criteria |
Gender Male |
Age 20Year~No Limit |
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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. |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Radiological and/or physical assessments of the tumor lesions |
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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 |
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Secondary Outcome(s) 1 | ||
Outcome | Safety evaluation |
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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 |
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Secondary Outcome(s) 2 | ||
Outcome | Prostate - specific antigen |
|
Timepoint | per 4 weeks |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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