RecruitingNot Applicable

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

China30 participantsStarted 2024-07-24

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Prostate Specific Antigen (PSA) Response Rate

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

Trial details

NCT IDNCT06529549

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-07-23

Contact for this trial

Yonghong Li, MD

02087343656 liyongh@sysucc.org.cn

View on ClinicalTrials.gov More Metastatic Castration-resistant Prostate Cancer trials