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| ID | Type | Description | Link |
|---|---|---|---|
| jRCTs071200040 | Registry Identifier | Japan Registry of Clinical Trial (jRCT) | |
| 56021927PCR4013 | Other Grant/Funding Number | Janssen Pharmaceutical K.K. |
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| Name | Class |
|---|---|
| Janssen Pharmaceutical K.K. | INDUSTRY |
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To evaluate changes in genomic alterations for 73 PC driver genes during apalutamide treatment
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apalutamide | Other | Apalutamide 240 mg administered orally once a day as four 60 mg tablets |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apalutamide | Drug | Apalutamide 240 mg administered orally once a day as four 60 mg tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in genomic alterations of 73 PC driver genes between pre- and posttreatment of apalutamide. | Seventy-three PC driver genes from ctDNA including ARID1A, HSD3B1, MDM4, AKT3, MSH2, MSH6, ERCC3, NFE2L2, IDH1, FANCD2, MLH1, CTNNB1, FOXP1, RYBP, PIK3CB, ATR, PIK3CA, FBXW7, PIK3R1, CHD1, APC, FANCE, CDK6, MET, BRAF, CUL1, KMT2C, NKX3-1, CLU, NCOA2, MYC, CDKN2A, FANCG, FANCC, PTEN, FANCF, CCND1, ATM, ZBTB16, CDKN1B, KRAS, KMT2D, CDK4, MDM2, BRCA2, RB1, ERCC5, FOXA1, RAD51B, AKT1, IDH2, ERCC4, ZFHX3, FANCA, TP53, CDK12, BRCA1, SPOP, RNF43, RAD51C, AKT2, ERCC2, ERCC1, ASXL1, GNAS, RUNX1, ERG, TMPRSS2, KDM6A, AR, MED12, SMARCA1, and PALB2. | Three years or more, 4.5 years or less |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants who achieve nadir PSA ≤0.2 ng/mL stratified by baseline genomic alterations for 73 PC driver genes | The proportion of participants who achieve nadir PSA ≤0.2 ng/mL is defined as the proportion of participants who achieve nadir PSA less than 0.2 ng/mL from apalutamide initiation. | Three years or more, 4.5 years or less |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hiroshi Yoshida | Contact | +81-3-3830-1074 | ctDNA@a2healthcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Hirotsugu Uemura, MD, PhD | Department of Urology, Kindai University Faculty of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kindai University Hospital | Recruiting | ÅŒsaka-sayama | Osaka | 589-851 | Japan |
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| ID | Term |
|---|---|
| C572045 | apalutamide |
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| PSA-PFS stratified by baseline genomic alterations for 73 PC driver genes | The PSA-PFS is defined as the duration from apalutamide initiation to either PSA progression or death, whichever occurs first. The PSA progression will be determined according to the PCWG3 criteria. | Three years or more, 4.5 years or less |
| PFS stratified by baseline genomic alterations for 73 PC driver genes | The PFS is defined as the duration from apalutamide initiation to either radiographic progression, clinical progression or death, whichever occurs first. The radiographic and clinical progression will be determined by an investigator's discretion. | Three years or more, 4.5 years or less |
| OS stratified by baseline genomic alterations for 73 PC driver genes | The OS is defined as the duration from apalutamide initiation to any death. | Three years or more, 4.5 years or less |
| Time to CRPC stratified by baseline genomic alterations for 73 PC driver genes | The time to CRPC is defined as the duration from apalutamide initiation to developing CRPC. The CRPC will be determined according to European Association of Urology (EAU) guidelines 2019. | Three years or more, 4.5 years or less |
| PFS2 stratified by baseline genomic alterations for 73 PC driver genes | The PFS2 is defined as the duration from apalutamide initiation to disease progression (PSA progression, radiographic progression, or clinical progression) on the first subsequent therapy for prostate cancer, whichever occurred first. The PSA progression will be determined according to the PCWG3 criteria. The radiographic and clinical progression will be determined by an investigator's discretion. | Three years or more, 4.5 years or less |
| Safety in the usual clinical practice based on adverse events | Safety observational period is defined as the treatment phase in this study. Adverse events that occur within 30 days after the last dose of apalutamide will be collected, except for lost to follow-up, death, or withdrawal of consent for study participation. For each adverse event, the percentage of participants who experience at least 1 occurrence of the given event will be summarized. | From apalutamide initiation to 30 days after the last dose |
| Safety in the usual clinical practice based on potential skin rash events | Safety observational period is defined as the treatment phase in this study. Potential skin rash events that occur within 30 days after the last dose of apalutamide will be collected, except for lost to follow-up, death, or withdrawal of consent for study participation. The percentage of participants who experience at least 1 occurrence of the given event will be summarized. | From apalutamide initiation to 30 days after the last dose |