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

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ClinicalTrials.gov Identifier: NCT04601441
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : December 8, 2020
Sponsor:
Collaborator:
Janssen Pharmaceutical K.K.
Information provided by (Responsible Party):
Hirotsugu Uemura, Kindai University

Study Description
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Brief Summary:
To evaluate changes in genomic alterations for 73 PC driver genes during apalutamide treatment

Condition or disease Intervention/treatment Phase
Metastatic Castration-sensitive Prostate Cancer Drug: Apalutamide Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Phase 4 Study of Exploring Circulating Tumor DNA (ctDNA) of Metastatic Castration-sensitive Prostate Cancer (mCSPC) Patients Receiving Apalutamide in Japan
Actual Study Start Date : November 6, 2020
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Apalutamide

Arms and Interventions
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Arm Intervention/treatment
Apalutamide
Apalutamide 240 mg administered orally once a day as four 60 mg tablets
 Drug: Apalutamide
Apalutamide 240 mg administered orally once a day as four 60 mg tablets


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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 ]
    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.

  2. PSA-PFS stratified by baseline genomic alterations for 73 PC driver genes [ Time Frame: Three years or more, 4.5 years or less ]
    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.

  3. PFS stratified by baseline genomic alterations for 73 PC driver genes [ Time Frame: Three years or more, 4.5 years or less ]
    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.

  4. OS stratified by baseline genomic alterations for 73 PC driver genes [ Time Frame: Three years or more, 4.5 years or less ]
    The OS is defined as the duration from apalutamide initiation to any death.

  5. Time to CRPC stratified by baseline genomic alterations for 73 PC driver genes [ Time Frame: Three years or more, 4.5 years or less ]
    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.

  6. PFS2 stratified by baseline genomic alterations for 73 PC driver genes [ Time Frame: Three years or more, 4.5 years or less ]
    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.

  7. Safety in the usual clinical practice based on adverse events [ Time Frame: From apalutamide initiation to 30 days after the last dose ]
    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.

  8. 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 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601441


Contacts
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Contact: Hiroshi Yoshida +81-3-3830-1074 ctDNA@a2healthcare.com

Locations
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Japan
Kindai University Hospital Recruiting
Ōsaka-sayama, Osaka, Japan, 589-851
Contact: Hirotsugu Uemura, MD, PhD         
Principal Investigator: Hirotsugu Uemura, MD, PhD         
Sponsors and Collaborators
Kindai University
Janssen Pharmaceutical K.K.
Investigators
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Study Chair: Hirotsugu Uemura, MD, PhD Department of Urology, Kindai University Faculty of Medicine
More Information
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Responsible Party: Hirotsugu Uemura, Professor, Kindai University
ClinicalTrials.gov Identifier: NCT04601441    
Other Study ID Numbers: 56021927PCR4013
jRCTs071200040 ( Registry Identifier: Japan Registry of Clinical Trial (jRCT) )
56021927PCR4013 ( Other Grant/Funding Number: Janssen Pharmaceutical K.K. )
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: December 8, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Hypersensitivity
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Immune System Diseases