Prostate Cancer Stage INCT03789253
Identify Genes/Pathways Responsible for Progression From Low Risk to Higher Risk Prostate Cancer
An observational study of Prostate Cancer Stage I, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In Taiwan, about 70% of new incident prostate cancer patients have localized disease. Most patients were detected by PSA screening. Among them, many had low-risk PC, which is very likely latent in nature, progresses slowly, and rarely leads to death. Read more about this study
- Who is it for?
- Ages 40 to 100 years, men only
- Conditions the study is for
- Prostate Cancer Stage I
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Jan 2019to 31 Jul 2030
- 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 40 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Low or intermediate risk prostate cancer patients receiving active surveillance
Who may be able to join
- Historically or cytologically confirmed adenocarcinoma of prostate.
- Have or ever received active Surveillance as the main conservative management at NTUH (National Taiwan University Hospital).
- Have or will receive prostate biopsy to confirm tumor progression after the diagnosis of prostate cancer.
Who cannot join
- Have received systemic chemotherapy, pelvic radiotherapy or androgen deprivation therapy (ADT) before the obtainment of pathological specimen from prostate operation or biopsy.
- Subjects who disagree with signing the informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University
Taipei, 10002
Yeong-Shiau Pu, PhD, 886-2-23123456 ext. 65950, yspu@ntu.edu.tw
Chung-Hsin Chen, PhD, 886-2-23123456 ext. 65242, mufasachen@gmail.com
About this study
Official title: Identify Genes/Pathways Responsible for Progression From Low Risk to Higher Risk Prostate Cancer-A New Strategy for Prostate Cancer Prevention
In Taiwan, about 70% of new incident prostate cancer patients have localized disease. Most patients were detected by PSA screening. Among them, many had low-risk PC, which is very likely latent in nature, progresses slowly, and rarely leads to death. Most patients died of other causes, such as other cancers, cardiovascular diseases, and diabetes mellitus. Many guidelines recommend that active surveillance (AS) or watchful waiting (WW) is a good option for low risk patients to avoid overtreatment-related complications. However, 30% of patients on AS will finally need definitive treatments due to disease progression within 10 years. We hypothesize that there are differential gene expressions between progressive and non-progressive tumors. If we can identify key genes or pathways that are responsible for progression of low risk PC to higher risk diseases, PC progression could be reduced substantially by regulating these genes or pathways and maintain long-term cancer latency to control non-metastatic PC. In light of the high prevalence rate of latent PC in adult men, the strategy is in fact the best strategy for preventing clinical PC.
Read the detailed description
At the Department of Urology, NTUH, we have established a largest Chinese AS/WW cohort, which were prospectively collected since 2013. There were already 280 AS and 100 WW patients. Most AS patients have undergone serial prostate re-biopsies every 1 to 2 years, which is actually our cutting edge in the field. 87 men had at least twice biopsies at our hospital (mean interval 15 months). 26 of them showed pathological progression (Group As) who have been treated aggressively. The other 61 men had no progression even after multiple biopsies (Group Bs). So, we may compare the genetic changes in each subject in Group A to reveal genetic changes responsible for progression. We can also compare baseline expressions between Group A and B to predict progression. We also can correlate genetic alterations in Group A with cancer phenotypes and short-term post-treatment outcomes.
Here are the four Specific Aims:
Aim-1. To investigate the role of known genes or pathways in mediating progression from low risk to higher risk by using serial biopsy paraffin embedded tissue blocks from our AS patients. These known genes/pathways are selected from published reports, which are found to be related to progression from low to higher grade PC, such as Ki-67, PTEN loss, and chromosome 8 alterations.
Aim-2. There was only one cDNA microarray gene bank (GSE37199) published in the literature (Lancet Oncol. 2012; 13:1114) that was associated with differential expression between AS and mCRPC cohorts. We will proceed with the Gene Set Enrichment Analysis (GSEA) to identify more potential genes or pathways that have NOT been specifically demonstrated relating to AS progression. These new genes or pathways will then be studied in Aim-1.
Aim-3. We will perform global cDNA microarray sing non-cancer part of the serial biopsy paraffin tissue blocks from our AS cohort, followed by GSEA to reveal differential gene expression between Group A and B patients. Hopefully we can identify genes/pathways that are related to progression of low risk or latent PC in Taiwanese.
Aim-4. To conduct multivariate analyses considering not only key genetic alterations but also multiple clinicopathological parameters to build up a model predicting progression from low to higher risk PC.
In fact, the only one published study (Lancet Oncol. 2012;13:1114) was to reveal differential cDNA expression in blood cells between AS and mCRPC cohorts, but not between progressive and non-progressive patients. Therefore, the study design was defective because the obtained differential expression may not reflect what really happened in low risk cancer progression. To our knowledge, there has been no differential genetic expression study or the GSEA study for AS cohort. In addition, we have the largest Taiwanese/Chinese cohort on AS/WW and abundant serial biopsy specimens. In summary, our study which focuses on genomic research on AS cohort is a new strategy to prevent clinical PC and is of high novelty and clinical implications.
- Conditions
- Prostate Cancer Stage I
- Keywords
- active surveillance, microarray, latent, GSEA, latent
- 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 |
|---|---|---|
| AS cohort with progression | AS cohort with tumor progression | |
| AS cohort without progression | AS cohort without tumor progression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene expression
Using GESA analysis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start2 Jan 2019
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Stage IStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yeong-Shiau Pu, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789253
- Sponsor's protocol ID
- 201712093RINB
- Status last verified
- Aug 2022
- First submitted
- 26 Dec 2018
- Last updated
- 12 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identify Genes/Pathways Responsible for Progression From Low Risk to Higher Risk Prostate Cancer-A New Strategy for Prostate Cancer Prevention
- ClinicalTrials.gov ID
- NCT03789253
- Acronym / sponsor ID
- 201712093RINB
- Conditions
- Prostate Cancer Stage I
- Keywords
- active surveillance, microarray, latent, GSEA, latent
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 28 Dec 2018 (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 Taiwan, about 70% of new incident prostate cancer patients have localized disease. Most patients were detected by PSA screening. Among them, many had low-risk PC, which is very likely latent in nature, progresses slowly, and rarely leads to death. Most patients died of other causes, such as other cancers, cardiovascular diseases, and diabetes mellitus. Many guidelines recommend that active surveillance (AS) or watchful waiting (WW) is a good option for low risk patients to avoid overtreatment-related complications. However, 30% of patients on AS will finally need definitive treatments due to disease progression within 10 years. We hypothesize that there are differential gene expressions between progressive and non-progressive tumors. If we can identify key genes or pathways that are responsible for progression of low risk PC to higher risk diseases, PC progression could be reduced substantially by regulating these genes or pathways and maintain long-term cancer latency to control non-metastatic PC. In light of the high prevalence rate of latent PC in adult men, the strategy is in fact the best strategy for preventing clinical PC.
Detailed description
At the Department of Urology, NTUH, we have established a largest Chinese AS/WW cohort, which were prospectively collected since 2013. There were already 280 AS and 100 WW patients. Most AS patients have undergone serial prostate re-biopsies every 1 to 2 years, which is actually our cutting edge in the field. 87 men had at least twice biopsies at our hospital (mean interval 15 months). 26 of them showed pathological progression (Group As) who have been treated aggressively. The other 61 men had no progression even after multiple biopsies (Group Bs). So, we may compare the genetic changes in each subject in Group A to reveal genetic changes responsible for progression. We can also compare baseline expressions between Group A and B to predict progression. We also can correlate genetic alterations in Group A with cancer phenotypes and short-term post-treatment outcomes.
Here are the four Specific Aims:
Aim-1. To investigate the role of known genes or pathways in mediating progression from low risk to higher risk by using serial biopsy paraffin embedded tissue blocks from our AS patients. These known genes/pathways are selected from published reports, which are found to be related to progression from low to higher grade PC, such as Ki-67, PTEN loss, and chromosome 8 alterations.
Aim-2. There was only one cDNA microarray gene bank (GSE37199) published in the literature (Lancet Oncol. 2012; 13:1114) that was associated with differential expression between AS and mCRPC cohorts. We will proceed with the Gene Set Enrichment Analysis (GSEA) to identify more potential genes or pathways that have NOT been specifically demonstrated relating to AS progression. These new genes or pathways will then be studied in Aim-1.
Aim-3. We will perform global cDNA microarray sing non-cancer part of the serial biopsy paraffin tissue blocks from our AS cohort, followed by GSEA to reveal differential gene expression between Group A and B patients. Hopefully we can identify genes/pathways that are related to progression of low risk or latent PC in Taiwanese.
Aim-4. To conduct multivariate analyses considering not only key genetic alterations but also multiple clinicopathological parameters to build up a model predicting progression from low to higher risk PC.
In fact, the only one published study (Lancet Oncol. 2012;13:1114) was to reveal differential cDNA expression in blood cells between AS and mCRPC cohorts, but not between progressive and non-progressive patients. Therefore, the study design was defective because the obtained differential expression may not reflect what really happened in low risk cancer progression. To our knowledge, there has been no differential genetic expression study or the GSEA study for AS cohort. In addition, we have the largest Taiwanese/Chinese cohort on AS/WW and abundant serial biopsy specimens. In summary, our study which focuses on genomic research on AS cohort is a new strategy to prevent clinical PC and is of high novelty and clinical implications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AS cohort with progression | – | –AS cohort with tumor progression |
| AS cohort without progression | – | –AS cohort without tumor progression |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Low or intermediate risk prostate cancer patients receiving active surveillance
Key inclusion criteria (3 listed)
- Historically or cytologically confirmed adenocarcinoma of prostate.
- Have or ever received active Surveillance as the main conservative management at NTUH (National Taiwan University Hospital).
- Have or will receive prostate biopsy to confirm tumor progression after the diagnosis of prostate cancer.
Key exclusion criteria (2 listed)
- Have received systemic chemotherapy, pelvic radiotherapy or androgen deprivation therapy (ADT) before the obtainment of pathological specimen from prostate operation or biopsy.
- Subjects who disagree with signing the informed consent.
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
Gene expression
Time frame: 3 years
Using GESA analysis
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 12 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Yeong-Shiau Pu, PhD principal investigator
National Taiwan 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 Stage I, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 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: looking for participants now, as of the sponsor's last update on 12 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 Taiwan. 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 Yeong-Shiau Pu, PhD (886-2-23123456 ext. 65950, yspu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gene expression (time frame: 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 12 Aug 2022.