Prostate CancerNCT06536725
Observation of Clinical Consistency of Organoid-chips Drug Sensitivity in Chemotherapy for PCa With Visceral Metastasis
An observational study of Prostate Cancer and Organoid, run by Tianjin Medical University Second Hospital at 2 sites in China.
Trial summary
This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Organoid
- What is being tested?
- Building Organoid-on-chips models
- How many people
- 35 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Prostate Cancer Patients With Visceral Metastasis
Who may be able to join
- Patients with visceral metastasis of prostate cancer diagnosed clinically or pathologically;
- Age ≥ 18 years old;
- ECOG score ≤ 2 points or ECOG score 3-4 points due to tumor progression;
- Normal liver and kidney function, serum transaminase ALT<66 U/L, AST<36 U/L, total bilirubin<22 umol/L, creatinine<106 umol/L, urea nitrogen<6.1 mmol/L; Normal bone marrow function: neutrophil count ≥ 1800/mm3 and platelet count ≥ 100000/mm3;
- Can obtain surgical or biopsy samples;
- Patients voluntarily join this study and sign an informed consent form.
Who cannot join
- Patients with severe heart, liver, kidney, and peripheral nervous system diseases, as well as autoimmune diseases such as hyperthyroidism and hypothyroidism; Systemic lupus erythematosus, etc;
- Patients who are unable to obtain tissue samples;
- Subjects with active pulmonary tuberculosis (TB);
- Subjects who are preparing for or have previously undergone tissue/organ transplantation;
- Exclusion criteria are not listed, but the researchers believe that patients who are not suitable to participate in this clinical study.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality, 300211
Haitao Wang, +86-02288326610, peterrock2000@126.com
Lili Wang, +86-13516108466, wangliliaigang@163.com
- Recruiting
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality
Haitao Wang, Ph.D, +86-022-88326385, peterrock2000@126.com
Lili Wang, MM, +86-022-88326610, wangliliaigang@163.com
About this study
Official title: Observation of Clinical Consistency of Organoid-on-chips Drug Sensitivity Detection in Chemotherapy for Prostate Cancer Patients With Visceral Metastasis
This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans.
Read the detailed description
This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans;The final medication regimen for patients is determined by doctors based on their experience and in vitro drug sensitivity results. The actual clinical efficacy of medication is tracked for patients, and the organoid chip drug sensitivity detection model is analyzed as a predictor of the sensitivity, specificity, and accuracy of anti-tumor chemotherapy drugs, providing data reference for clinical applications.At the same time, analyze the accuracy of drug sensitivity testing results and clinical empirical medication.If patients are treated with a chemotherapy combined with immunotherapy regimen, the in vitro sensitivity of immune drugs will be determined using organoid-immune co-culture technology, and exploratory research on the predictive performance of immune models will be conducted in conjunction with clinical medication.
- Conditions
- Prostate Cancer, Organoid
- Being tested
- Building Organoid-on-chips models
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Building Organoid-on-chips modelsOther
This project obtains surgical or biopsy samples from prostate cancer patients with visceral metastasis for the construction of organoids.
| Study group | Role | What they receive |
|---|---|---|
| PCa Patients With Visceral Metastasis | Prostate cancer patients with visceral metastasis. Receives: Other: Building Organoid-on-chips models |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR(Objective Response Rate)
Selecting ORR as the primary endpoint from clinical efficacy evaluation indicators.Evaluation of the best objective response rate (ORR) for each treatment according to RECIST 1.1. The best ORR is the best response reached during treatment according to RECIST 1.1 criteria.
Measured: 18 months
Clinical Consistency
Sensitivity, specificity, and accuracy of drug sensitivity testing results based on successfully constructed organoids for predicting the main clinical efficacy evaluation indicators.
Measured: 18 months
Secondary outcomes (2)
Changes in tumor markers levels
The main tumor marker monitored is TPSA.The levels of PSA will be monitored every 3 (or 4) weeks for comparison to baseline levels until the time of PSA progression, as defined by PCWG3 criteria.The levels of other tumor markers will be monitored every 3 (or 4) weeks for comparison to baseline levels until the time of tumor markers progression.
Measured: 18 months
PFS(Progression-free survival)
Progression-free survival (PFS) is defined as the time from the date of the first administration of patients medication plan based on organoids drug sensitivity test to the date of the first documentation of disease progression or death due to any cause, whichever comes first, censored at the last date at which the participant was determined to be progression-free.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Jun 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536725
- Sponsor's protocol ID
- Organoid-on-chips-PCa
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Clinical Consistency of Organoid-on-chips Drug Sensitivity Detection in Chemotherapy for Prostate Cancer Patients With Visceral Metastasis
- ClinicalTrials.gov ID
- NCT06536725
- Acronym / sponsor ID
- Organoid-on-chips-PCa
- Conditions
- Prostate Cancer, Organoid
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Tianjin Medical University Second HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Aug 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 project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans.
Detailed description
This project plans to establish an organoid chip model of prostate cancer patients with internal organ metastasis from surgical or biopsy tissue sources, and test the sensitivity of commonly used chemotherapy drugs based on organoid chip drug sensitivity testing technology to screen out sensitive individualized treatment plans;The final medication regimen for patients is determined by doctors based on their experience and in vitro drug sensitivity results. The actual clinical efficacy of medication is tracked for patients, and the organoid chip drug sensitivity detection model is analyzed as a predictor of the sensitivity, specificity, and accuracy of anti-tumor chemotherapy drugs, providing data reference for clinical applications.At the same time, analyze the accuracy of drug sensitivity testing results and clinical empirical medication.If patients are treated with a chemotherapy combined with immunotherapy regimen, the in vitro sensitivity of immune drugs will be determined using organoid-immune co-culture technology, and exploratory research on the predictive performance of immune models will be conducted in conjunction with clinical medication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCa Patients With Visceral Metastasis | – | Other: Building Organoid-on-chips modelsProstate cancer patients with visceral metastasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prostate Cancer Patients With Visceral Metastasis
Key inclusion criteria (6 listed)
- Patients with visceral metastasis of prostate cancer diagnosed clinically or pathologically;
- Age ≥ 18 years old;
- ECOG score ≤ 2 points or ECOG score 3-4 points due to tumor progression;
- Normal liver and kidney function, serum transaminase ALT<66 U/L, AST<36 U/L, total bilirubin<22 umol/L, creatinine<106 umol/L, urea nitrogen<6.1 mmol/L; Normal bone marrow function: neutrophil count ≥ 1800/mm3 and platelet count ≥ 100000/mm3;
- Can obtain surgical or biopsy samples;
Key exclusion criteria (5 listed)
- Patients with severe heart, liver, kidney, and peripheral nervous system diseases, as well as autoimmune diseases such as hyperthyroidism and hypothyroidism; Systemic lupus erythematosus, etc;
- Patients who are unable to obtain tissue samples;
- Subjects with active pulmonary tuberculosis (TB);
- Subjects who are preparing for or have previously undergone tissue/organ transplantation;
- Exclusion criteria are not listed, but the researchers believe that patients who are not suitable to participate in this clinical study.
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 |
|---|---|---|
| Building Organoid-on-chips modelsThis project obtains surgical or biopsy samples from prostate cancer patients with visceral metastasis for the construction of organoids. | Other | PCa Patients With Visceral Metastasis |
Primary outcome
ORR(Objective Response Rate)
Time frame: 18 months
Selecting ORR as the primary endpoint from clinical efficacy evaluation indicators.Evaluation of the best objective response rate (ORR) for each treatment according to RECIST 1.1. The best ORR is the best response reached during treatment according to RECIST 1.1 criteria.
Clinical Consistency
Time frame: 18 months
Sensitivity, specificity, and accuracy of drug sensitivity testing results based on successfully constructed organoids for predicting the main clinical efficacy evaluation indicators.
2 secondary outcomes
Changes in tumor markers levels
Time frame: 18 months
PFS(Progression-free survival)
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Organoid, run by Tianjin Medical University Second Hospital at 2 sites 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haitao Wang, Ph.D (+86-022-88326385, peterrock2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR(Objective Response Rate) (time frame: 18 months). The study lists 2 primary outcomes in all. 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 5 Aug 2024.