Prostate CancerNCT05522907
Investigation of Tumor Microenvironment After CRPC Along With Before and After Neoadjuvant Therapy for Prostate Cancer
An observational study of Prostate Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
In recent years, the clinical research of immunotherapy including PD-1 antibody and CD3 bispecific antibody in prostate cancer has been increasing day by day. The comparison with the analysis results of cancer tissues of advanced patients has important guiding significance for the application of these new treatment… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 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 Any age
- Men only
- Child, Adult, Older adult
Study population: Prostate cancer patients who underwent prostate cancer biopsy before neoadjuvant therapy, underwent radical prostatectomy 3-6 months after neoadjuvant therapy. Patients were diagnosed with CRPC.
Who may be able to join
- The patient was diagnosed with prostate cancer.
- The patient underwent neoadjuvant therapy or was diagnosed with CRPC.
Who cannot join
- When it is detected that the patient has a viral infection that interferes with the human genome, such as HIV infection, etc.
- Biopsy and/or surgically removed prostate cancer tissue was not eligible for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Lei Li, PhD, 0086-15991752560, lilydr@163.com
Tianjie Liu, PhD, 0086-15809228721, liutj2016@163.com
About this study
Official title: Comparative Study of Tumor Microenvironment Between Early and Advanced Prostate Cancer Through Multi-omics
In recent years, the clinical research of immunotherapy including PD-1 antibody and CD3 bispecific antibody in prostate cancer has been increasing day by day. The comparison with the analysis results of cancer tissues of advanced patients has important guiding significance for the application of these new treatment methods.
In a retrospective study, investigators plan to perform multi-omics analysis (including whole exome, RNAseq), immune cell characterization, and biopsy samples from prostate cancer primary biopsy, ADT neoadjuvant, and CRPC biopsy samples in the biobank. Protein and prostate cancer-specific antigen expression were analyzed by immunohistochemistry. The following questions are answered by comparing samples from different treatment stages in early and advanced stages: 1. Whether the immune environment becomes "cold" in the advanced stage; 2. Which immune cell populations have changed significantly; 3. Is the inhibitory immune microenvironment related to genes Mutations or suppressive immune cell populations.
Read the detailed description
Prostate cancer is a high incidence of cancer in Europe and the United States. In recent years, due to factors such as increasing awareness of testing and an aging population, the incidence of prostate cancer in China has been increasing year by year, and it has become the sixth most common cancer in men. Most of the patients with middle-advanced prostate cancer respond to ADT treatment, but the vast majority of patients eventually develop castration-resistant prostate cancer (CRPC) after the disease recurs or continues to progress after castration treatment. The related drug resistance mechanism is mainly caused by abnormal AR signaling pathway, including AR gene amplification, AR splicing variant and AR coregulator activation and other factors. In recent years, studies have shown that inhibitory immune cell infiltration and immune microenvironment also promote the emergence of CRPC. The cytokine IL-23 secreted by infiltrating myeloid-derived suppressor cells (MDSCs) can activate the STAT3-RORγ pathway, which in turn activates the AR pathway, resulting in resistance to ADT and other AR-targeted therapies. In addition, advanced prostate cancer tissue has always been considered to be a relatively "cold" immune microenvironment with relatively little immune cell infiltration. Metastatic castration-resistant prostate cancer (mCRPC) lacks efficacy against immune checkpoint inhibitors such as PD-1, and only those with mismatch repair gene deficiency (dMMR) or microsatellite instability-high (MSI-H) have must benefit. Most studies have only focused on patients with advanced CRPC without systematically comparing the immune microenvironment of patients with early and advanced prostate cancer. Advances in next-generation sequencing (NGS) technologies have led to a greater understanding of genomic alterations in prostate cancer. The most common genomic abnormalities in this malignancy are the TMPRSS2-ETS transcription factor fusion, and mutations in TP53, AR, RB1, and PTEN/PIK3CA. Some of these abnormalities are already targeted with clinically available drugs. At present, there have been large-scale foreign research on prostate cancer, such as "The Cancer Genome Atlas" (TCGA), "International Cancer Genome Consortium" (ICGC), etc., and a western cancer omics research system has been established. In the Chinese Prostate Cancer Genome and Epigenome Atlas (CPGEA) study, the incidence of the hallmark ETS fusion (53% TCGA) was much lower in the Chinese prostate cancer population (9% CPGEA) in contrast to Western prostate cancer . Among Chinese prostate cancers, the highest gene fusion rates were SCHLAP1-UBE2E3 (29%) and PAOX-MTG1 (10%), and the researchers found that FOXA1 was the gene with the highest mutation rate (41%) in our Chinese prostate cancer patients. In terms of methylation, the Chinese cohort study is similar to the Western cohort, the prostate cancer genome is hypomethylated relative to normal prostate tissue, and the 5' untranslated region (UTR) and CpG island (CGI) are relatively hypermethylated, while the penetrance Introns, introns and repeat elements are hypomethylated. Megabase-scale partially methylated domains (PMDs) are widespread and affect up to half of the cancer genome, suggesting that tumor progression correlates with the extent of genome-wide hypomethylation.
Given the many differences in the genomes of Chinese and western prostate cancer patients, the response of Chinese prostate cancer patients to various treatments and the changes in gene, transcription, and translation levels after treatment may also be different from foreign prostate cancer patients. However, NGS data for Chinese prostate cancer patients before and after chemotherapy, endocrine therapy, radiotherapy, or immunotherapy are still missing. The NGS data of these patients before and after treatment will provide new drug design targets and new drug development ideas for prostate cancer treatment in China, and will also provide a solid theoretical basis for the optimization of existing treatment methods.
- Conditions
- Prostate Cancer
- Keywords
- Neoadjuvant, CRPC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant | From the beginning of the project for the past five years to the next three years, underwent prostate cancer biopsies at the First Affiliated Hospital of Xi'an Jiaotong University before neoadjuvant therapy, and underwent radical prostatectomy after 3-6 months of neoadjuvant therapy. | |
| CRPC | Patients with CRPC-diagnosed prostate cancer after initial continuous ADT therapy, with serum testosterone reaching castration levels (<50ng/dl or <1.7nmol/L) but with progressive disease, and who were diagnosed with CRPC at Xi'an Jiaotong University The First Affiliated Hospital did a prostate cancer biopsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
FFPE samples requirements
- H\&E stained slide (tumor area marked, tumor content >= 20%).
- Standard sample request:5-10 unstained slides, thickness 4-5um,0.6mm3 (matched to H\&E slide).
Measured: From the date of participants recruitment to the date of collection of at least 80 eligible FFPE samples, assessed up to 36 months.
Quality requirements for RNA extracted from FFPE samples
Standard sample request: more than 300ng total RNA, concentration: more than 20ng/ul, volume: more than 10 ul, DV200: more than 30%. Minimum sample request: more than 150ng total RNA, concentration: more than 20ng/ul, volume: more than 10 ul,DV200: more than 30%.
Measured: From the date of participants recruitment to the date of collection of at least 80 eligible FFPE samples, assessed up to 36 months.
Quality requirements for DNA extracted from FFPE samples
Standard sample request: more than 2.2ug total RNA,concentration: more than 50ng/ul,volume: more than 10 ul,RIN: more than 8.Minimum sample request: more than 1.1ug total RNA,concentration: more than 50ng/ul,volume: more than 10 ul,RIN: more than 8.
Measured: From the date of participants recruitment to the date of collection of at least 80 eligible FFPE samples, assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion31 Dec 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.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Li, PhD, Study chair, First Affiliated Hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05522907
- Sponsor's protocol ID
- XJTU1AF2021CRF-002
- Status last verified
- Aug 2022
- First submitted
- 16 Aug 2022
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Tumor Microenvironment Between Early and Advanced Prostate Cancer Through Multi-omics
- ClinicalTrials.gov ID
- NCT05522907
- Acronym / sponsor ID
- XJTU1AF2021CRF-002
- Conditions
- Prostate Cancer
- Keywords
- Neoadjuvant, CRPC
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Aug 2022 (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.
In recent years, the clinical research of immunotherapy including PD-1 antibody and CD3 bispecific antibody in prostate cancer has been increasing day by day. The comparison with the analysis results of cancer tissues of advanced patients has important guiding significance for the application of these new treatment methods.
In a retrospective study, investigators plan to perform multi-omics analysis (including whole exome, RNAseq), immune cell characterization, and biopsy samples from prostate cancer primary biopsy, ADT neoadjuvant, and CRPC biopsy samples in the biobank. Protein and prostate cancer-specific antigen expression were analyzed by immunohistochemistry. The following questions are answered by comparing samples from different treatment stages in early and advanced stages: 1. Whether the immune environment becomes "cold" in the advanced stage; 2. Which immune cell populations have changed significantly; 3. Is the inhibitory immune microenvironment related to genes Mutations or suppressive immune cell populations.
Detailed description
Prostate cancer is a high incidence of cancer in Europe and the United States. In recent years, due to factors such as increasing awareness of testing and an aging population, the incidence of prostate cancer in China has been increasing year by year, and it has become the sixth most common cancer in men. Most of the patients with middle-advanced prostate cancer respond to ADT treatment, but the vast majority of patients eventually develop castration-resistant prostate cancer (CRPC) after the disease recurs or continues to progress after castration treatment. The related drug resistance mechanism is mainly caused by abnormal AR signaling pathway, including AR gene amplification, AR splicing variant and AR coregulator activation and other factors. In recent years, studies have shown that inhibitory immune cell infiltration and immune microenvironment also promote the emergence of CRPC. The cytokine IL-23 secreted by infiltrating myeloid-derived suppressor cells (MDSCs) can activate the STAT3-RORγ pathway, which in turn activates the AR pathway, resulting in resistance to ADT and other AR-targeted therapies. In addition, advanced prostate cancer tissue has always been considered to be a relatively "cold" immune microenvironment with relatively little immune cell infiltration. Metastatic castration-resistant prostate cancer (mCRPC) lacks efficacy against immune checkpoint inhibitors such as PD-1, and only those with mismatch repair gene deficiency (dMMR) or microsatellite instability-high (MSI-H) have must benefit. Most studies have only focused on patients with advanced CRPC without systematically comparing the immune microenvironment of patients with early and advanced prostate cancer. Advances in next-generation sequencing (NGS) technologies have led to a greater understanding of genomic alterations in prostate cancer. The most common genomic abnormalities in this malignancy are the TMPRSS2-ETS transcription factor fusion, and mutations in TP53, AR, RB1, and PTEN/PIK3CA. Some of these abnormalities are already targeted with clinically available drugs. At present, there have been large-scale foreign research on prostate cancer, such as "The Cancer Genome Atlas" (TCGA), "International Cancer Genome Consortium" (ICGC), etc., and a western cancer omics research system has been established. In the Chinese Prostate Cancer Genome and Epigenome Atlas (CPGEA) study, the incidence of the hallmark ETS fusion (53% TCGA) was much lower in the Chinese prostate cancer population (9% CPGEA) in contrast to Western prostate cancer . Among Chinese prostate cancers, the highest gene fusion rates were SCHLAP1-UBE2E3 (29%) and PAOX-MTG1 (10%), and the researchers found that FOXA1 was the gene with the highest mutation rate (41%) in our Chinese prostate cancer patients. In terms of methylation, the Chinese cohort study is similar to the Western cohort, the prostate cancer genome is hypomethylated relative to normal prostate tissue, and the 5' untranslated region (UTR) and CpG island (CGI) are relatively hypermethylated, while the penetrance Introns, introns and repeat elements are hypomethylated. Megabase-scale partially methylated domains (PMDs) are widespread and affect up to half of the cancer genome, suggesting that tumor progression correlates with the extent of genome-wide hypomethylation.
Given the many differences in the genomes of Chinese and western prostate cancer patients, the response of Chinese prostate cancer patients to various treatments and the changes in gene, transcription, and translation levels after treatment may also be different from foreign prostate cancer patients. However, NGS data for Chinese prostate cancer patients before and after chemotherapy, endocrine therapy, radiotherapy, or immunotherapy are still missing. The NGS data of these patients before and after treatment will provide new drug design targets and new drug development ideas for prostate cancer treatment in China, and will also provide a solid theoretical basis for the optimization of existing treatment methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant | – | –From the beginning of the project for the past five years to the next three years, underwent prostate cancer biopsies at the First Affiliated Hospital of Xi'an Jiaotong University before neoadjuvant therapy, and underwent radical prostatectomy after 3-6 months of neoadjuvant therapy. |
| CRPC | – | –Patients with CRPC-diagnosed prostate cancer after initial continuous ADT therapy, with serum testosterone reaching castration levels (<50ng/dl or <1.7nmol/L) but with progressive disease, and who were diagnosed with CRPC at Xi'an Jiaotong University The First Affiliated Hospital did a prostate cancer biopsy. |
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- Prostate cancer patients who underwent prostate cancer biopsy before neoadjuvant therapy, underwent radical prostatectomy 3-6 months after neoadjuvant therapy. Patients were diagnosed with CRPC.
Key inclusion criteria (2 listed)
- The patient was diagnosed with prostate cancer.
- The patient underwent neoadjuvant therapy or was diagnosed with CRPC.
Key exclusion criteria (2 listed)
- When it is detected that the patient has a viral infection that interferes with the human genome, such as HIV infection, etc.
- Biopsy and/or surgically removed prostate cancer tissue was not eligible for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FFPE samples requirements
Time frame: From the date of participants recruitment to the date of collection of at least 80 eligible FFPE samples, assessed up to 36 months.
1. H\&E stained slide (tumor area marked, tumor content >= 20%). 2. Standard sample request:5-10 unstained slides, thickness 4-5um,0.6mm3 (matched to H\&E slide).
Quality requirements for RNA extracted from FFPE samples
Time frame: From the date of participants recruitment to the date of collection of at least 80 eligible FFPE samples, assessed up to 36 months.
Standard sample request: more than 300ng total RNA, concentration: more than 20ng/ul, volume: more than 10 ul, DV200: more than 30%. Minimum sample request: more than 150ng total RNA, concentration: more than 20ng/ul, volume: more than 10 ul,DV200: more than 30%.
Quality requirements for DNA extracted from FFPE samples
Time frame: From the date of participants recruitment to the date of collection of at least 80 eligible FFPE samples, assessed up to 36 months.
Standard sample request: more than 2.2ug total RNA,concentration: more than 50ng/ul,volume: more than 10 ul,RIN: more than 8.Minimum sample request: more than 1.1ug total RNA,concentration: more than 50ng/ul,volume: more than 10 ul,RIN: more than 8.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
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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.
Lei Li, PhD study chair
First Affiliated Hospital of Xian Jiaotong University
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 Prostate Cancer, run by First Affiliated Hospital Xi'an Jiaotong 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 2 inclusion and 2 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 31 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Li, PhD (0086-15991752560, lilydr@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FFPE samples requirements (time frame: From the date of participants recruitment to the date of collection of at least 80 eligible FFPE samples, assessed up to 36 months.). The study lists 3 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 31 Aug 2022.