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Trial record 92 of 1544 for:    Androgens

An Open Label Phase II Study of Biweekly Docetaxel Plus Androgen-Deprivation Therapy in Patients With Previously-Untreated, Metastatic, Prostatic Adenocarcinoma

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03061643
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : May 20, 2019
Information provided by (Responsible Party):
Park, Se-Hoon, Samsung Medical Center

Brief Summary:
Study of Biweekly Docetaxel plus Androgen-Deprivation Therapy (ADT) in Patients with Previously-Untreated, Metastatic, Prostatic Adenocarcinoma

Condition or disease Intervention/treatment Phase
Prostatic Neoplasm Drug: Docetaxel Other: Androgen-Deprivation Therapy (ADT) Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : February 8, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Docetaxel PLUS ADT
receive docetaxel 40 mg/m2 IV every 2 weeks plus ADT
Drug: Docetaxel
docetaxel 40 mg/m2 IV every 2 weeks plus ADT

Other: Androgen-Deprivation Therapy (ADT)
docetaxel 40 mg/m2 IV every 2 weeks plus ADT

Primary Outcome Measures :
  1. Time-to-CRPC (biochemical or clinical) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  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):
  8. Acceptable renal function with serum creatinine
  9. Acceptable liver function:
  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:

  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.

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 identifier (NCT number): NCT03061643

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Contact: SEHOON SEHOON, MD,PhD 82-2-3410-3767

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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135710
Contact: Se Hoon Park, MD    +82 2 3410 3459   
Sponsors and Collaborators
Samsung Medical Center
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Principal Investigator: SEHOON SEHOON, MD,PhD SamsungMedicalCenter

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Responsible Party: Park, Se-Hoon, Samsung Medical Center Identifier: NCT03061643     History of Changes
Other Study ID Numbers: 2017-01-005
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs