An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Place… (NCT04076059) | Clinical Trial Compass
Active — Not RecruitingPhase 3
An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)
China180 participantsStarted 2019-09-11
Plain-language summary
The purpose of this study was to evaluate the efficacy and safety of enzalutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT in Chinese subjects with metastatic hormone sensitive prostate cancer (mHSPC). The study was conducted in two phases: Double-Blind treatment phase and open-label phase.
Who can participate
Age range18 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Double Blind treatment Phase:
* Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology.
* Subject has metastatic prostate cancer documented by positive bone scan (for bone disease) or measurable metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan (for soft tissue). Subjects whose disease spread is limited to regional pelvic lymph nodes are not eligible.
* Once randomized at day 1, subject must maintain androgen deprivation therapy (ADT) with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist during study treatment or have a history of bilateral orchiectomy (i.e., medical or surgical castration).
* Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
* Subject has an estimated life expectancy of ≥ 12 months.
* Subject is able to swallow the study drug and comply with study requirements.
* A sexually active male subject with female partner(s) who is of childbearing potential is eligible if:
* Agrees to use a male condom starting at screening and continue throughout the study treatment and for at least 3 months after the last dose of study drug. If the male subject has not had a vasectomy or is not sterile at least 6 months prior to screening his female partner(s) is utilizing 1 form of highly effective birth control per locally accepted…
What they're measuring
1
Time to Prostrate Specific Antigen (PSA) Progression
Timeframe: From the date of randomization to the first observation of PSA progression (up to 38 months)