Metastatic Castration-resistant Prostate CancerNCT05116579
Circulating Tumor DNA (ctDNA) Monitoring in the Assessment and Prediction of the Efficacy of PARP Inhibitors (PARPi)
An observational study of Metastatic Castration-resistant Prostate Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
To evaluate the application value of customized ctDNA monitoring in efficacy assessment and prediction during PARPi treatment Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2021to 31 Aug 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 18 to 75 years
- Men only
- Adult, Older adult
Study population: clinic-based sample
Who may be able to join
- Patients must meet ALL of the following criteria:
- Willing and able to provide informed consent.
- Adult males from 18 to 75 years age.
- History of histologically or cytologically confirmed adenocarcinoma of the prostate with Homologous Recombination Deficiency or DDR genes mutation (BRCA1/2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L) detected by high throughput sequencing
- Documented evidence of metastatic castration resistant prostate cancer (mCRPC) and proposed treatment of PARP inhibitors.
- Evidence of measurable target lesion in imaging studies.
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- Participants can provide adequate formalin fixed paraffin-embedded (FFPE) tumor tissue collected before any treatment: tumor cell content>30% and necrotic cells<10%.
- ECOG performance status 0-1
- Estimated survival≥12 weeks
Who cannot join
- Patients must NOT meet any of the following criteria:
- Do not meet the inclusion criteria.
- Under any other anti-tumor therapy like chemotherapy and/or immunotherapy.
- Receiving organ transplantation in the last 3 months.
- Participants with autoimmune diseases or history of HBV, HCV or HIV infection (acute or chronic).
- Participants with pneumonia.
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- Severe concurrent illness or co-morbid disease that would make the subject unsuitable for enrolment
- Unwilling and unable to provide informed consent.
- Patients who are judged unsuitable for clinical trial participation by the investigators.
- Elimination Criteria:
- Violation of the prescribed rule of medication that may influence the judgment of curative effect and safety.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Yonghong Li, M.D., +020-87343656, liyongh@sysucc.org.cn
Fangjian Zhou, M.D., +020-87343656, zhoufj@sysucc.org.cn
About this study
To evaluate the application value of customized ctDNA monitoring in efficacy assessment and prediction during PARPi treatment
Read the detailed description
This clinical study is an open-label, single-center, observational study to evaluate the application value of customized ctDNA monitoring in efficacy assessment and prediction during PARPi treatment in mCRPC patients. A total of 30 participants with second-line treatment failure will be registered in this study. Whole blood collection will be conducted during the treatment for ctDNA detection, homologous recombination repair (HRR) genes testing, personalized panel customization and whole exome sequencing.
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological progression free survival (rPFS)
Radiological progression free survival (rPFS) - defined as the time from randomisation to radiological progression, assessed by investigator per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 (soft tissue) and Prostate Cancer Working Group-3 (PCWG-3) criteria (bone), or death from any cause, or the last follow-up, whichever occurs first
Measured: From date of randomisation to until radiographic progression (up to 1 year)
Objective Response Rate (ORR)
ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)). Per RECIST v1.1, CR=Disappearance of all target lesions; PR = >=30% decrease in the sum of diameters of target lesions; For each treatment group, ORR is the number of patients with a CR and PR.
Measured: From randomisation until radiographic progression (up to 1 year)
PSA response rate
PSA response rate is defined as the proportion of patients with a PSA decline (defined as a ≥30%, ≥50% and other declines in PSA from baseline).
Measured: From randomisation until radiographic progression (up to 1 year)
Secondary outcomes (1)
Overall Survival (OS)
OS is defined as time from treatment commencement to death of any cause
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start31 Oct 2021
- Primary completion31 Mar 2023
- Study completion31 Aug 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-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonghong Li, Sun Yat-sen University
- Investigators
- Yonghong Li, M.D., Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116579
- Sponsor's protocol ID
- 2021-FXY-171
- Status last verified
- Aug 2024
- First submitted
- 1 Nov 2021
- Last updated
- 5 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA (ctDNA) Monitoring in the Assessment and Prediction of the Efficacy of PARP Inhibitors (PARPi)
- ClinicalTrials.gov ID
- NCT05116579
- Acronym / sponsor ID
- 2021-FXY-171
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 31 Oct 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 11 Nov 2021 (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 the application value of customized ctDNA monitoring in efficacy assessment and prediction during PARPi treatment
Detailed description
This clinical study is an open-label, single-center, observational study to evaluate the application value of customized ctDNA monitoring in efficacy assessment and prediction during PARPi treatment in mCRPC patients. A total of 30 participants with second-line treatment failure will be registered in this study. Whole blood collection will be conducted during the treatment for ctDNA detection, homologous recombination repair (HRR) genes testing, personalized panel customization and whole exome sequencing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- clinic-based sample
Key inclusion criteria (9 listed)
- Willing and able to provide informed consent.
- Adult males from 18 to 75 years age.
- History of histologically or cytologically confirmed adenocarcinoma of the prostate with Homologous Recombination Deficiency or DDR genes mutation (BRCA1/2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, RAD54L) detected by high throughput sequencing
- Documented evidence of metastatic castration resistant prostate cancer (mCRPC) and proposed treatment of PARP inhibitors.
- Evidence of measurable target lesion in imaging studies.
Key exclusion criteria (11 listed)
- Do not meet the inclusion criteria.
- Under any other anti-tumor therapy like chemotherapy and/or immunotherapy.
- Receiving organ transplantation in the last 3 months.
- Participants with autoimmune diseases or history of HBV, HCV or HIV infection (acute or chronic).
- Participants with pneumonia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Radiological progression free survival (rPFS)
Time frame: From date of randomisation to until radiographic progression (up to 1 year)
Radiological progression free survival (rPFS) - defined as the time from randomisation to radiological progression, assessed by investigator per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 (soft tissue) and Prostate Cancer Working Group-3 (PCWG-3) criteria (bone), or death from any cause, or the last follow-up, whichever occurs first
Objective Response Rate (ORR)
Time frame: From randomisation until radiographic progression (up to 1 year)
ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)). Per RECIST v1.1, CR=Disappearance of all target lesions; PR = >=30% decrease in the sum of diameters of target lesions; For each treatment group, ORR is the number of patients with a CR and PR.
PSA response rate
Time frame: From randomisation until radiographic progression (up to 1 year)
PSA response rate is defined as the proportion of patients with a PSA decline (defined as a ≥30%, ≥50% and other declines in PSA from baseline).
1 secondary outcome
Overall Survival (OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
Related trials for Metastatic Castration-resistant Prostate Cancer
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A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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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.
Yonghong Li, M.D. principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castration-resistant Prostate Cancer, run by Sun Yat-sen University at 1 site in China.
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 9 inclusion and 11 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 5 Sep 2024. 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 China. 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.
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 Yonghong Li, M.D. (+020-87343656, liyongh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological progression free survival (rPFS) (time frame: From date of randomisation to until radiographic progression (up to 1 year)). The study lists 3 primary outcomes in all. 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 5 Sep 2024.