Monitoring ctDNA to assess PARP inhibitor effectiveness in prostate cancer

Circulating Tumor DNA (ctDNA) Monitoring in the Assessment and Prediction of the Efficacy of PARP Inhibitors (PARPi)

This study is testing if tracking a specific type of DNA in the blood can help doctors see how well a new prostate cancer treatment works for men whose previous therapies have failed.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Male
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05116579 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of customized circulating tumor DNA (ctDNA) monitoring in assessing and predicting the efficacy of PARP inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC). The study will enroll 30 adult male participants who have experienced treatment failure with second-line therapies. Blood samples will be collected during treatment to detect ctDNA, test for homologous recombination repair (HRR) gene mutations, and perform whole exome sequencing. The goal is to personalize treatment approaches based on ctDNA analysis.

Who should consider this trial

Good fit: Ideal candidates are adult males aged 18 to 75 with mCRPC and specific HRR gene mutations.

Not a fit: Patients without documented HRR gene mutations or those not eligible for PARP inhibitor treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized treatment strategies for patients with mCRPC.

How similar studies have performed: Other studies have shown promise in using ctDNA monitoring for treatment assessment, indicating potential success for this approach.

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Yonghong Li, M.D. — Sun Yat-sen University
• Study coordinator: Yonghong Li, M.D.

Conditions: Metastatic Castration-resistant Prostate Cancer