Clinical trial NCT05116579: Circulating Tumor DNA (ctDNA) Monitoring in the Assessment and Prediction of the Efficacy of PARP Inhibitors (PARPi)
Official title: Circulating Tumor DNA (ctDNA) Monitoring in the Assessment and Prediction of the Efficacy of PARP Inhibitors (PARPi)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metastatic Castration-resistant Prostate Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-11-11
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: clinic-based sample

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

Patients must meet ALL of the following criteria:

1. Willing and able to provide informed consent.
2. Adult males from 18 to 75 years age.
3. 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
4. Documented evidence of metastatic castration resistant prostate cancer (mCRPC) and proposed treatment of PARP inhibitors.
5. Evidence of measurable target lesion in imaging studies.
6. Participants can provide adequate formalin fixed paraffin-embedded (FFPE) tumor tissue collected before any treatment: tumor cell content\>30% and necrotic cells\<10%.
7. ECOG performance status 0-1
8. Estimated survival≥12 weeks

Exclusion Criteria:

Patients must NOT meet any of the following criteria:

1. Do not meet the inclusion criteria.
2. Under any other anti-tumor therapy like chemotherapy and/or immunotherapy.
3. Receiving organ transplantation in the last 3 months.
4. Participants with autoimmune diseases or history of HBV, HCV or HIV infection (acute or chronic).
5. Participants with pneumonia.
6. Severe concurrent illness or co-morbid disease that would make the subject unsuitable for enrolment
7. Unwilling and unable to provide informed consent.
8. 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.

Primary outcomes:
measure: Radiological progression free survival (rPFS)
timeFrame: From date of randomisation to until radiographic progression (up to 1 year)
measure: Objective Response Rate (ORR)
timeFrame: From randomisation until radiographic progression (up to 1 year)
measure: PSA response rate
timeFrame: From randomisation until radiographic progression (up to 1 year)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Yonghong Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: