Clinical trial NCT04601441: Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Metastatic Castration-sensitive Prostate Cancer
Lead sponsor: Kindai University
Sponsor class: OTHER
Collaborators: name: Janssen Pharmaceutical K.K.
First posted: 2020-10-23
Enrollment: 100
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Changes in genomic alterations of 73 PC driver genes between pre- and posttreatment of apalutamide.
timeFrame: Three years or more, 4.5 years or less
Secondary outcomes:
measure: The proportion of participants who achieve nadir PSA ≤0.2 ng/mL stratified by baseline genomic alterations for 73 PC driver genes
timeFrame: Three years or more, 4.5 years or less
measure: PSA-PFS stratified by baseline genomic alterations for 73 PC driver genes
timeFrame: Three years or more, 4.5 years or less
measure: PFS stratified by baseline genomic alterations for 73 PC driver genes
timeFrame: Three years or more, 4.5 years or less
measure: OS stratified by baseline genomic alterations for 73 PC driver genes
timeFrame: Three years or more, 4.5 years or less
measure: Time to CRPC stratified by baseline genomic alterations for 73 PC driver genes
timeFrame: Three years or more, 4.5 years or less
measure: PFS2 stratified by baseline genomic alterations for 73 PC driver genes
timeFrame: Three years or more, 4.5 years or less
measure: Safety in the usual clinical practice based on adverse events
timeFrame: From apalutamide initiation to 30 days after the last dose
measure: Safety in the usual clinical practice based on potential skin rash events
timeFrame: From apalutamide initiation to 30 days after the last dose
Other outcomes:
Locations:
city: Ōsaka-sayama
country: Japan
facility: Kindai University Hospital
state: Osaka
Study officials:
affiliation: Department of Urology, Kindai University Faculty of Medicine
name: Hirotsugu Uemura, MD, PhD
role: STUDY_CHAIR
References: