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

NCT03061643 | Unknown Phase 2 FDA Drug

• 1 other identifier: 2017-01-005
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostatic Neoplasm

Outcome Measures

Primary Outcomes (1)

• Time-to-CRPC (biochemical or clinical)

  24 months

Secondary Outcomes (1)

• Progression-free survival

  36 months

Study Arms (1)

Docetaxel PLUS ADT

EXPERIMENTAL

receive docetaxel 40 mg/m2 IV every 2 weeks plus ADT

Drug: Docetaxel; Other: Androgen-Deprivation Therapy (ADT)

Interventions

Docetaxel DRUG

docetaxel 40 mg/m2 IV every 2 weeks plus ADT

Docetaxel PLUS ADT

Androgen-Deprivation Therapy (ADT) OTHER

docetaxel 40 mg/m2 IV every 2 weeks plus ADT

Docetaxel PLUS ADT

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a male at least 20 years of age.
• Subject has a histologically or cytologically confirmed diagnosis of adenocarcinoma of prostate.
• 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.
• Subject has an ECOG performance status of 0 to 1.
• Subject has a life expectancy of 3 months or more.
• 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.
• Acceptable hematologic status (without growth factor support or transfusion dependency):
• Acceptable renal function with serum creatinine
• Acceptable liver function:
• 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.
• Written and voluntary informed consent understood, signed and dated.

You may not qualify if:

• Ongoing treatment with an anticancer agent not contemplated in this protocol
• Pathologic finding consistent with neuroendocrine or small cell carcinoma
• 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.
• Non-tolerable \>Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1
• 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.
• Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery.
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
• Subjects who have exhibited allergic reactions to taxanes.
• 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.
• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135710, South Korea

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Docetaxel; Androgen Antagonists

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• SEHOON SEHOON, MD,PhD

  SamsungMedicalCenter

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Samsung Medical Center

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 23, 2017
• Study Start: February 8, 2017
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-03

Locations

KR (1)