Using organoid testing to guide treatment for advanced prostate cancer
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
This study is testing if using lab-grown mini tumors from prostate cancer patients can help doctors choose better treatments for men with advanced prostate cancer that hasn't responded to initial therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Male |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06529549 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the efficacy and safety of organoid-based drug sensitivity screening in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after first-line treatment. The study aims to determine if treatment decisions based on organoid screening results lead to improved patient responses. Participants will provide residual tissue from previously collected bone metastasis biopsies for organoid culture, which will be used to assess drug sensitivity. The study focuses on adult males aged 18 to 75 with documented mCRPC.
Who should consider this trial
Good fit: Ideal candidates are adult males aged 18 to 75 with confirmed mCRPC who have progressed after first-line treatment.
Not a fit: Patients currently undergoing other anti-tumor therapies or those with severe concurrent illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment options for patients with advanced prostate cancer.
How similar studies have performed: While organoid-based drug sensitivity screening is a novel approach, similar methodologies have shown promise in other cancer types, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Yonghong Li, MD
- Email: liyongh@sysucc.org.cn
- Phone: 02087343656
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.