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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
100
Apalutamide 240 mg administered orally once a day as four 60 mg tablets
Kindai University Hospital
Ōsaka-sayama, Osaka, Japan
RECRUITINGChanges 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.
Time frame: Three years or more, 4.5 years or less
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.
Time frame: Three years or more, 4.5 years or less
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.
Time frame: 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.
Time frame: Three years or more, 4.5 years or less
OS stratified by baseline genomic alterations for 73 PC driver genes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The OS is defined as the duration from apalutamide initiation to any death.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From apalutamide initiation to 30 days after the last dose