Image

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

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

Recruiting
18-75 years
Male
Phase N/A

Powered by AI

Overview

To evaluate the application value of customized ctDNA monitoring in efficacy assessment and prediction during PARPi treatment

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

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.

Study details
    Metastatic Castration-resistant Prostate Cancer

NCT05116579

Sun Yat-sen University

21 October 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.