Efficacy and Safety of Organoid-Based Drug Sensitivity Screening to Guide the Treatment of mCRPC Patients Progressed After First-line Treatment
Recruiting · NCT06529549 · Observational (researchers observe without assigning treatment) · Lead sponsor: Sun Yat-sen University
View the official record on ClinicalTrials.gov →Interventions studied
Organoid-Based Drug Sensitivity Screening
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
1 location listed.
- Sun Yat-sen University Cancer Center - Guangzhou, Guangdong, China