Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan

Sponsor
Kindai University
Study ID
NCT04601441
Phase
PHASE4
Status
Unknown

Conditions

  • Metastatic Castration-sensitive Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apalutamide — DRUG
    Apalutamide 240 mg administered orally once a day as four 60 mg tablets

Study Details

To evaluate changes in genomic alterations for 73 PC driver genes during apalutamide treatment

Key Dates

Start date
Nov 6, 2020
Status verified
Dec 2020
Primary completion
Mar 31, 2025
Completion
Mar 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Other: Apalutamide
    Apalutamide 240 mg administered orally once a day as four 60 mg tablets

Primary Outcome Measure

Changes in genomic alterations of 73 PC driver genes between pre- and posttreatment of apalutamide. [ Time Frame: Three years or more, 4.5 years or less ]

Central Contacts

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