Metastatic Castration-sensitive Prostate Cancer Metastatic Castration-sensitive Prostate Cancer
Conditions
Interventions
Blood collection for ctDNA, SNPs, and HLA typing
Sponsors
Uemura Hirotsugu
Okazaki Sachie
Watanabe Aki
Janssen Pharmaceutical K.K.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in genomic alterations of 73 PC driver genes between pre- and posttreatment of apalutamide | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactHirotsugu Uemura
Kindai University Hospital
Outcome results
None listed