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Tests organoid-guided drug choice in men with advanced prostate cancer

Studies whether lab-grown tumor models guide treatment for prostate cancer that has spread to bone.

Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Organoid-Based Drug Sensitivity Screening to Guide the Treatment of mCRPC Patients Progressed After First-line Treatment

Key facts

Where
Guangzhou, ChinaSee the site

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT06529549, who can take part

Where in China

  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Sun Yat-sen University
Trial code
NCT06529549
Record updated
31 July 2024
Original description
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:Read full original descriptionShow less

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 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.

Inclusion: 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.

Exclusion: 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; Participants with autoimmune diseases or history of HBV, HCV or HIV infection (acute); 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.

ClinicalTrials.gov NCT06529549