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Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan (CUARTET)

Primary Purpose

Metastatic Castration-sensitive Prostate Cancer

Status
Recruiting
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Apalutamide
Sponsored by
Kindai University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Metastatic Castration-sensitive Prostate Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Kindai University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Apalutamide

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
OS stratified by baseline genomic alterations for 73 PC driver genes
The OS is defined as the duration from apalutamide initiation to any death.
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.
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.
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.
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.

Full Information

First Posted
October 12, 2020
Last Updated
December 6, 2020
Sponsor
Kindai University
Collaborators
Janssen Pharmaceutical K.K.
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1. Study Identification

Unique Protocol Identification Number
NCT04601441
Brief Title
Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan
Acronym
CUARTET
Official Title
Phase 4 Study of Exploring Circulating Tumor DNA (ctDNA) of Metastatic Castration-sensitive Prostate Cancer (mCSPC) Patients Receiving Apalutamide in Japan
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Recruiting
Study Start Date
November 6, 2020 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kindai University
Collaborators
Janssen Pharmaceutical K.K.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-sensitive Prostate Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Apalutamide
Arm Type
Other
Arm Description
Apalutamide 240 mg administered orally once a day as four 60 mg tablets
Intervention Type
Drug
Intervention Name(s)
Apalutamide
Intervention Description
Apalutamide 240 mg administered orally once a day as four 60 mg tablets
Primary Outcome Measure Information:
Title
Changes in genomic alterations of 73 PC driver genes between pre- and posttreatment of apalutamide.
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.
Time Frame
Three years or more, 4.5 years or less
Secondary Outcome Measure Information:
Title
The proportion of participants who achieve nadir PSA ≤0.2 ng/mL stratified by baseline genomic alterations for 73 PC driver genes
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.
Time Frame
Three years or more, 4.5 years or less
Title
PSA-PFS stratified by baseline genomic alterations for 73 PC driver genes
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.
Time Frame
Three years or more, 4.5 years or less
Title
PFS stratified by baseline genomic alterations for 73 PC driver genes
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.
Time Frame
Three years or more, 4.5 years or less
Title
OS stratified by baseline genomic alterations for 73 PC driver genes
Description
The OS is defined as the duration from apalutamide initiation to any death.
Time Frame
Three years or more, 4.5 years or less
Title
Time to CRPC stratified by baseline genomic alterations for 73 PC driver genes
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.
Time Frame
Three years or more, 4.5 years or less
Title
PFS2 stratified by baseline genomic alterations for 73 PC driver genes
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.
Time Frame
Three years or more, 4.5 years or less
Title
Safety in the usual clinical practice based on adverse events
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.
Time Frame
From apalutamide initiation to 30 days after the last dose
Title
Safety in the usual clinical practice based on potential skin rash events
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.
Time Frame
From apalutamide initiation to 30 days after the last dose

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hiroshi Yoshida
Phone
+81-3-3830-1074
Email
ctDNA@a2healthcare.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hirotsugu Uemura, MD, PhD
Organizational Affiliation
Department of Urology, Kindai University Faculty of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Kindai University Hospital
City
Ōsaka-sayama
State/Province
Osaka
ZIP/Postal Code
589-851
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hirotsugu Uemura, MD, PhD
First Name & Middle Initial & Last Name & Degree
Hirotsugu Uemura, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan

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