Clinical Trials /

Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan

NCT04601441

Description:

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

Related Conditions:
  • Prostate Adenocarcinoma
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan
  • Official Title: Phase 4 Study of Exploring Circulating Tumor DNA (ctDNA) of Metastatic Castration-sensitive Prostate Cancer (mCSPC) Patients Receiving Apalutamide in Japan

Clinical Trial IDs

  • ORG STUDY ID: 56021927PCR4013
  • SECONDARY ID: jRCTs071200040
  • SECONDARY ID: 56021927PCR4013
  • NCT ID: NCT04601441

Conditions

  • Metastatic Castration-sensitive Prostate Cancer

Interventions

DrugSynonymsArms
ApalutamideApalutamide

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
ApalutamideOtherApalutamide 240 mg administered orally once a day as four 60 mg tablets
  • Apalutamide

Eligibility Criteria

        Inclusion Criteria:

          -  Men aged ≥20 years.

          -  Participant has documented diagnosis of metastatic PC with histologically or
             cytologically confirmed adenocarcinoma of the prostate without neuroendocrine
             differentiation or small cell histology.

          -  Participant has metastatic PC that is castration naïve or castration sensitive and is
             permitted to receive less than 6-months ADT or CAB before registration and less than
             36-months neoadjuvant or adjuvant hormonal therapy.

          -  If a participant is treated with ADT or CAB, he has maintained a response to hormonal
             therapy of stable disease or better, by investigator assessment of imaging and PSA.

          -  Participant is willing to receive apalutamide for mCSPC in the participating site of
             this study.

          -  Participant is of Japanese nationality.

          -  Participant must sign an ICF indicating that he or she understands the purpose of, and
             procedures required for, the study and is willing to participate in the study.

        Exclusion Criteria:

          -  Participant does not agree to assess ctDNA including 73 PC driver genes, SNPs, and HLA
             typing.

          -  Participant has received any prior therapy of abiraterone, docetaxel, enzalutamide,
             apalutamide or darolutamide.

          -  Participant has known allergies, hypersensitivity, or intolerance to apalutamide or
             its excipients (refer to the package insert).

          -  Participant has contraindications to the use of ADT based on routine treatment.

          -  Participant has any condition for which, in the opinion of the investigator,
             participation would not be in the best interest of the participant (e.g., compromise
             the well-being) or that could prevent, limit, or confound the evaluation of active
             double cancer, etc.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

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
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:The proportion of participants who achieve nadir PSA ≤0.2 ng/mL stratified by baseline genomic alterations for 73 PC driver genes
Time Frame:Three years or more, 4.5 years or less
Safety Issue:
Description: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.
Measure:PSA-PFS stratified by baseline genomic alterations for 73 PC driver genes
Time Frame:Three years or more, 4.5 years or less
Safety Issue:
Description: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.
Measure:PFS stratified by baseline genomic alterations for 73 PC driver genes
Time Frame:Three years or more, 4.5 years or less
Safety Issue:
Description: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.
Measure:OS stratified by baseline genomic alterations for 73 PC driver genes
Time Frame:Three years or more, 4.5 years or less
Safety Issue:
Description:The OS is defined as the duration from apalutamide initiation to any death.
Measure:Time to CRPC stratified by baseline genomic alterations for 73 PC driver genes
Time Frame:Three years or more, 4.5 years or less
Safety Issue:
Description: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.
Measure:PFS2 stratified by baseline genomic alterations for 73 PC driver genes
Time Frame:Three years or more, 4.5 years or less
Safety Issue:
Description: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.
Measure:Safety in the usual clinical practice based on adverse events
Time Frame:From apalutamide initiation to 30 days after the last dose
Safety Issue:
Description: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.
Measure:Safety in the usual clinical practice based on potential skin rash events
Time Frame:From apalutamide initiation to 30 days after the last dose
Safety Issue:
Description: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.

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Kindai University

Last Updated

October 23, 2020