NCT06529549Recruiting
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
Source: ClinicalTrials.gov · Last updated 31 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 26 Jul 2024
- Start date
- 24 Jul 2024
- Primary completion date
- 23 Jul 2027
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Prostate cancer
- NCT number
- NCT06529549
What you commit to
- Study type: Observational
- Planned participants: 30
- From 24 Jul 2024 to the primary completion date, 23 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Under any other anti-tumor therapy like chemotherapy and/or immunotherapy.
- Receiving organ transplantation in the last 3 months.
- Severe concurrent illness or co-morbid disease that would make the subject unsuitable for enrolment
Other illness
- Participants with autoimmune diseases or history of HBV, HCV or HIV infection (acute).
Other
- Do not meet the inclusion criteria.
- Participants with pneumonia.
- Unwilling and unable to provide informed consent.
- Patients who are judged unsuitable for clinical trial participation by the investigators.
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.