Trials / Unknown
UnknownNCT04601441
Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan
Phase 4 Study of Exploring Circulating Tumor DNA (ctDNA) of Metastatic Castration-sensitive Prostate Cancer (mCSPC) Patients Receiving Apalutamide in Japan
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Kindai University · Academic / Other
- Sex
- Male
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate changes in genomic alterations for 73 PC driver genes during apalutamide treatment
Detailed description
This clinical study is an open-label, multicenter, interventional, Phase 4 study to evaluate changes in genomic alterations for 73 PC driver genes during apalutamide treatment in patients with mCSPC. A total of 100 participants to be treated by apalutamide will be registered in this study. All participants will undergo blood collection for ctDNA, single-nucleotide polymorphisms (SNPs), and human-leukocyte antigen (HLA) typing at pre- and posttreatment of apalutamide.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Apalutamide | Apalutamide 240 mg administered orally once a day as four 60 mg tablets |
Timeline
- Start date
- 2020-11-06
- Primary completion
- 2025-03-31
- Completion
- 2025-03-31
- First posted
- 2020-10-23
- Last updated
- 2020-12-08
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT04601441. Inclusion in this directory is not an endorsement.