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

Sun Yat-sen University30 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Metastatic Castration-resistant Prostate Cancer

Interventions

Organoid-Based Drug Sensitivity ScreeningOTHER

Residual tissue of bone metastatic sites from biopsies for genetic testing will be collected to culture organoid and perform drug sensitivity screening

Eligibility

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Prostate Specific Antigen (PSA) Response Rate

Proportion of patients with a 50% decrease in PSA from baseline

Time frame: From enrollment to primary completion of study (up to approximately 3 years)

Secondary Outcomes

Radiologic Progression-free Survival (rPFS)

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.

Time frame: 3 years

Objective Response Rate (ORR)

Proportion of patients in complete remission (CR) plus partial remission (PR)

Time frame: From enrollment to primary completion of study (up to approximately 3 years)

Duration of Response (DOR)

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.

Time frame: From enrollment to primary completion of study (up to approximately 3 years)

Overall Survival (OS)

Time between the start of treatment and death from any cause

Time frame: From enrollment to primary completion of study (up to approximately 3 years)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts