RECRUITINGOBSERVATIONAL

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

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

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: 1. Willing and able to provide willing to sign a consent form. 2. Adult males from 18 to 75 years age. 3. History of diagnosed by tissue sample (biopsy-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. You should be able to carry out daily activities with 0 level of ability (ECOG 0)-1 7. Estimated survival≥12 weeks Who Should NOT Join This Trial: 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 conditions (where your immune system attacks your own body)s 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 willing to sign a consent form. 8. Patients who are judged unsuitable for clinical trial participation by the investigators. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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

Locations (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China