Efficacy and Safety of Organoid-Based Drug Sensitivity Screening to Guide the Treatment of mCRPC Patients Progressed After First-line Treatment
NCT ID: NCT06529549
Last Updated: 2024-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2024-07-24
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Organoid-Based Drug Sensitivity Screening
Organoid culture and 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
MALE
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Yonghong Li
Professor
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-FXY-231
Identifier Type: -
Identifier Source: org_study_id
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