Metastatic Castration-resistant Prostate Cancer
Conditions
Brief summary
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
OTHEROrganoid-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
Sponsors
Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Specific Antigen (PSA) Response Rate | From enrollment to primary completion of study (up to approximately 3 years) | Proportion of patients with a 50% decrease in PSA from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiologic Progression-free Survival (rPFS) | 3 years | Radiologic progression-free survival will be assessed from the time of the first dose to radiologic disease progression or death from any cause, whichever comes first. |
| Objective Response Rate (ORR) | From enrollment to primary completion of study (up to approximately 3 years) | Proportion of patients in complete remission (CR) plus partial remission (PR) |
| Duration of Response (DOR) | From enrollment to primary completion of study (up to approximately 3 years) | Time from the start of the first assessment of the tumor as CR or PR to the first assessment of PD (Progressive Disease) or death from any cause. |
| Overall Survival (OS) | From enrollment to primary completion of study (up to approximately 3 years) | Time between the start of treatment and death from any cause |
Countries
China
Contacts
Primary ContactYonghong Li, MD
Backup ContactDiwei Zhao
Outcome results
None listed