Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan

NCT04601441 | Unknown Phase 4

• 2 other identifiers: 56021927PCR4013jRCTs071200040
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Metastatic Castration-sensitive Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• The proportion of participants who achieve nadir PSA ≤0.2 ng/mL stratified by baseline genomic alterations for 73 PC driver genes

  Three years or more, 4.5 years or less

• PSA-PFS stratified by baseline genomic alterations for 73 PC driver genes

  Three years or more, 4.5 years or less

• PFS stratified by baseline genomic alterations for 73 PC driver genes

  Three years or more, 4.5 years or less

• OS stratified by baseline genomic alterations for 73 PC driver genes

  Three years or more, 4.5 years or less

• Time to CRPC stratified by baseline genomic alterations for 73 PC driver genes

  Three years or more, 4.5 years or less

Study Arms (1)

Apalutamide

OTHER

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

Drug: Apalutamide

Interventions

Apalutamide DRUG

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

Apalutamide

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kindai University: lead
• Janssen Pharmaceutical K.K.: collaborator

Study Sites (1)

Kindai University Hospital

Ōsaka-sayama, Osaka, 589-851, Japan

RECRUITING

MeSH Terms

Interventions

apalutamide

Study Officials

• Hirotsugu Uemura, MD, PhD

  Department of Urology, Kindai University Faculty of Medicine

  STUDY CHAIR

Central Study Contacts

Hiroshi Yoshida

CONTACT

+81-3-3830-1074; ctDNA@a2healthcare.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 12, 2020
• First Posted: October 23, 2020
• Study Start: November 6, 2020
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)