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Clinical Trials in China / NCT06529549
Recruiting Observational

Efficacy and Safety of Organoid-Based Drug Sensitivity Screening to Guide the Treatment of mCRPC Patients Progressed After First-line Treatment

NCT06529549 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Observational
Started
2024-07-24
Last updated
2024-07-31

Condition(s) studied

Metastatic Castration-resistant Prostate Cancer

Investigational drug(s) / intervention(s)

Organoid-Based Drug Sensitivity Screening

Organoid-Based Drug Sensitivity Screening: Residual tissue of bone metastatic sites from biopsies for genetic testing will be collected to culture organoid and perform drug sensitivity screening

Study summary

This observational study aims to learn about the effects and safety of organoid-based drug sensitivity screening in mCRPC patients with bone metastases that progressed after first-line treatment. The main question it seeks to answer is:

Do doctors choose treatment agents based on organoid-based drug sensitivity screening results for mCRPC patients, resulting in a better response?

Participants already took bone metastasis biopsies for genetic testing based on current clinical guidelines. This study only takes residual tissue from biopsies for organoid culture.

Eligibility

Sex
MALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion 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 4. Documented evidence of metastatic castration resistant prostate cancer (mCRPC) and progressed after first-line treatment at mCRPC. 5. Evidence of target lesion in imaging studies. 6. ECOG performance status 0-1 7. Estimated survival≥12 weeks Exclusion 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). 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06529549 on ClinicalTrials.gov ↗ ← All trials in China