CUARTET Study

JRCT ID: jRCTs071200040

Registered date:09/10/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Metastatic Castration-sensitive Prostate Cancer
• Date of first enrollment: 06/11/2020
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Blood collection for ctDNA, SNPs, and HLA typing

Outcome(s)

• Primary Outcome: Changes in genomic alterations of 73 PC driver genes between pre- and posttreatment of apalutamide

Secondary Outcome

The proportion of participants who achieve nadir PSA 0.2 ng/mL or less stratified by baseline genomic alterations for 73 PC driver genes
PSA PFS stratified by baseline genomic alterations for 73 PC driver genes
PFS stratified by baseline genomic alterations for 73 PC driver genes
OS stratified by baseline genomic alterations for 73 PC driver genes
Time to CRPC stratified by baseline genomic alterations for 73 PC driver genes
PFS2 stratified by baseline genomic alterations for 73 PC driver genes
Safety in the usual clinical practice based on adverse events and potential skin rash events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Male

Include criteria

1. Men aged 20 years or older.
2. Participant has documented diagnosis of metastatic PC with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell histology.
3. Participant has metastatic PC that is castration naive 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.
4. 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.
5. Participant is willing to receive apalutamide for mCSPC in the participating site of this study.
6. Participant is of Japanese nationality.
7. 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.

Exclude criteria

1.Participant does not agree to assess ctDNA including 73 PC driver genes, SNPs, and HLA typing.
2.Participant has received any prior therapy of abiraterone, docetaxel, enzalutamide, apalutamide or darolutamide.
3.Participant has known allergies, hypersensitivity, or intolerance to apalutamide or its excipients (refer to the package insert).
4.Participant has contraindications to the use of ADT based on routine treatment.
5.Participant has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the evaluation of active double cancer, etc.

Related Information

• Primary Sponsor: Uemura Hirotsugu
• Secondary Sponsor: Okazaki Sachie,Kamiya Tsunekuni,Janssen Pharmaceutical K.K.
• Secondary ID(s): NCT04601441