Metastatic Castration-resistant Prostate CancerNCT06529549
Efficacy and Safety of Organoid-Based Drug Sensitivity Screening to Guide the Treatment of mCRPC Patients Progressed After First-line Treatment
An observational study of Metastatic Castration-resistant Prostate Cancer, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Organoid-Based Drug Sensitivity Screening
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2024to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: mCRPC patients with bone metastases and progressed after first-line treatment of mCRPC stage
Who may be able to join
- 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
Who cannot join
- Do not meet the inclusion criteria.
- Under any other anti-tumor therapy like chemotherapy and/or immunotherapy.
- Receiving organ transplantation in the last 3 months.
- Participants with autoimmune diseases or history of HBV, HCV or HIV infection (acute).
- Participants with pneumonia.
- Severe concurrent illness or co-morbid disease that would make the subject unsuitable for enrolment
- Unwilling and unable to provide informed consent.
- Patients who are judged unsuitable for clinical trial participation by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Yonghong Li, liyongh@sysucc.org.cn
Diwei Zhao, 15989568094, zhaodw@sysucc.org.cn
About this study
Official title: 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.
- Being tested
- Organoid-Based Drug Sensitivity Screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Organoid-Based Drug Sensitivity Screening | Organoid culture and drug sensitivity screening Receives: Other: Organoid-Based Drug Sensitivity Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate Specific Antigen (PSA) Response Rate
Proportion of patients with a 50% decrease in PSA from baseline
Measured: From enrollment to primary completion of study (up to approximately 3 years)
Secondary outcomes (4)
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.
Measured: 3 years
Objective Response Rate (ORR)
Proportion of patients in complete remission (CR) plus partial remission (PR)
Measured: 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.
Measured: 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
Measured: From enrollment to primary completion of study (up to approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start24 Jul 2024 (estimated)
- Primary completion23 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yonghong Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06529549
- Sponsor's protocol ID
- 2024-FXY-231
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06529549
- Acronym / sponsor ID
- 2024-FXY-231
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 24 Jul 2024 (estimated)
- Primary completion
- 23 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Organoid-Based Drug Sensitivity Screening | – | Other: Organoid-Based Drug Sensitivity ScreeningOrganoid culture and drug sensitivity screening |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mCRPC patients with bone metastases and progressed after first-line treatment of mCRPC stage
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- Do not meet the inclusion criteria.
- Under any other anti-tumor therapy like chemotherapy and/or immunotherapy.
- Receiving organ transplantation in the last 3 months.
- Participants with autoimmune diseases or history of HBV, HCV or HIV infection (acute).
- Participants with pneumonia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organoid-Based Drug Sensitivity ScreeningResidual tissue of bone metastatic sites from biopsies for genetic testing will be collected to culture organoid and perform drug sensitivity screening | Other | Organoid-Based Drug Sensitivity Screening |
Primary outcome
Prostate Specific Antigen (PSA) Response Rate
Time frame: From enrollment to primary completion of study (up to approximately 3 years)
Proportion of patients with a 50% decrease in PSA from baseline
4 secondary outcomes
Radiologic Progression-free Survival (rPFS)
Time frame: 3 years
Objective Response Rate (ORR)
Time frame: From enrollment to primary completion of study (up to approximately 3 years)
Duration of Response (DOR)
Time frame: From enrollment to primary completion of study (up to approximately 3 years)
Overall Survival (OS)
Time frame: From enrollment to primary completion of study (up to approximately 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Castration-resistant Prostate Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yonghong Li, MD (02087343656, liyongh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate Specific Antigen (PSA) Response Rate (time frame: From enrollment to primary completion of study (up to approximately 3 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.