Efficacy and Safety of Organoid-Based Drug Sensitivity Screening to Guide the Treatment of mCRPC Patients Progressed After First-line Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Organoid-Based Drug Sensitivity Screening.
- Who it may be relevant to
- Registry conditions: Metastatic Castration-resistant Prostate Cancer. Basic parameters: 18 years — 75 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, Open-label, Single-arm Study on the Efficacy and Safety of Organoid-Based Drug Sensitivity Screening to Guide the Treatment of mCRPC Patients With Bone Metastasis Progressed After First-line Treatment
Overview
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.
Interventions
- Other 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
Primary outcome measures
- Prostate Specific Antigen (PSA) Response Rate [Time frame: From enrollment to primary completion of study (up to approximately 3 years)]
Secondary outcome measures (4)
- Radiologic Progression-free Survival (rPFS) [Time frame: 3 years]
- Objective Response Rate (ORR) [Time frame: From enrollment to primary completion of study (up to approximately 3 years)]
- Duration of Response (DOR) [Time frame: From enrollment to primary completion of study (up to approximately 3 years)]
- Overall Survival (OS) [Time frame: From enrollment to primary completion of study (up to approximately 3 years)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT06529549 · 2024-FXY-231