Metastatic Castration-sensitive Prostate CancerPhase 4CUARTETNCT04601441
Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan
A Phase 4 study testing Apalutamide in people with Metastatic Castration-sensitive Prostate Cancer, run by Kindai University at 1 site in Japan.
Trial summary
To evaluate changes in genomic alterations for 73 PC driver genes during apalutamide treatment Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Metastatic Castration-sensitive Prostate Cancer
- What is being tested?
- Apalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- 6 Nov 2020to 31 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kindai University Hospital
Ōsaka-sayama, Osaka, 589-851
Hirotsugu Uemura, MD, PhD
Hirotsugu Uemura, MD, PhD
About this study
Official title: Phase 4 Study of Exploring Circulating Tumor DNA (ctDNA) of Metastatic Castration-sensitive Prostate Cancer (mCSPC) Patients Receiving Apalutamide in Japan
To evaluate changes in genomic alterations for 73 PC driver genes during apalutamide treatment
Read the 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.
- Being tested
- Apalutamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApalutamideDrug
Apalutamide 240 mg administered orally once a day as four 60 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Apalutamide | Other | Apalutamide 240 mg administered orally once a day as four 60 mg tablets Receives: Drug: Apalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Three years or more, 4.5 years or less
PSA-PFS stratified by baseline genomic alterations for 73 PC driver genes
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.
Measured: Three years or more, 4.5 years or less
PFS stratified by baseline genomic alterations for 73 PC driver genes
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.
Measured: Three years or more, 4.5 years or less
OS stratified by baseline genomic alterations for 73 PC driver genes
The OS is defined as the duration from apalutamide initiation to any death.
Measured: Three years or more, 4.5 years or less
Time to CRPC stratified by baseline genomic alterations for 73 PC driver genes
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.
Measured: Three years or more, 4.5 years or less
PFS2 stratified by baseline genomic alterations for 73 PC driver genes
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.
Measured: Three years or more, 4.5 years or less
Safety in the usual clinical practice based on adverse events
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.
Measured: From apalutamide initiation to 30 days after the last dose
Safety in the usual clinical practice based on potential skin rash events
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.
Measured: From apalutamide initiation to 30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start6 Nov 2020
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-sensitive Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kindai University
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Pharmaceutical K.K.
- Responsible party
- Principal investigator, Hirotsugu Uemura, Kindai University
- Investigators
- Hirotsugu Uemura, MD, PhD, Study chair, Department of Urology, Kindai University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601441
- Sponsor's protocol ID
- 56021927PCR4013
- Other IDs
- jRCTs071200040, 56021927PCR4013
- Acronym
- CUARTET
- Status last verified
- Dec 2020
- First submitted
- 12 Oct 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Exploring Circulating Tumor DNA (ctDNA) of Metastatic Castration-sensitive Prostate Cancer (mCSPC) Patients Receiving Apalutamide in Japan
- ClinicalTrials.gov ID
- NCT04601441
- Acronym / sponsor ID
- CUARTET / 56021927PCR4013
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kindai UniversityUniversity, hospital or other
- Collaborators
- Janssen Pharmaceutical K.K.
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apalutamide | Other | Drug: ApalutamideApalutamide 240 mg administered orally once a day as four 60 mg tablets |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApalutamideApalutamide 240 mg administered orally once a day as four 60 mg tablets | Drug | Apalutamide |
Primary outcome
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.
8 secondary outcomes
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
PSA-PFS stratified by baseline genomic alterations for 73 PC driver genes
Time frame: Three years or more, 4.5 years or less
PFS stratified by baseline genomic alterations for 73 PC driver genes
Time frame: Three years or more, 4.5 years or less
OS stratified by baseline genomic alterations for 73 PC driver genes
Time frame: Three years or more, 4.5 years or less
Time to CRPC stratified by baseline genomic alterations for 73 PC driver genes
Time frame: Three years or more, 4.5 years or less
PFS2 stratified by baseline genomic alterations for 73 PC driver genes
Time frame: Three years or more, 4.5 years or less
Safety in the usual clinical practice based on adverse events
Time frame: From apalutamide initiation to 30 days after the last dose
Safety in the usual clinical practice based on potential skin rash events
Time frame: From apalutamide initiation to 30 days after the last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hirotsugu Uemura, MD, PhD study chair
Department of Urology, Kindai University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Apalutamide in people with Metastatic Castration-sensitive Prostate Cancer, run by Kindai University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hiroshi Yoshida (+81-3-3830-1074, ctDNA@a2healthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.