Efficacy and Safety of Organoid-Based Drug Sensitivity Screening to Guide the Treatment of mCRPC Patients Progressed After First-line Treatment
Recruiting now
Conditions studied: Metastatic Castration-resistant Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT06529549
- Run by
- Sun Yat-sen University
- People needed
- 30
- Starts
- 2024-07-24
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2024-07-31
Who can join
Age: 18 and older, up to 75. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Willing and able to provide informed consent.
- Adult males from 18 to 75 years age.
- History of histologically or cytologically confirmed adenocarcinoma
- Documented evidence of metastatic castration resistant prostate cancer (mCRPC) and progressed after first-line treatment at mCRPC.
- Evidence of target lesion in imaging studies.
- ECOG performance status 0-1
- Estimated survival≥12 weeks
You may not qualify if…
- 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).
- Participants with pneumonia.
- 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.
Where it is running
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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