Prostate CancerNCT03237026
Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients
An observational study of Prostate Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The study aims to identify potential urine marker metabolites as predictive or prognostic markers for treatment outcomes in patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 30 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 360 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Oct 2017to 31 Jul 2031
- 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 30 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: A. Expected subject number to be enrolled: 360 men at NTUH. 1. Radical prostatectomy (OP, N=100): 50 subjects each for Cohort A and Cohort B, respectively. 2. Radiotherapy (RT, N=140): 70 subjects each for Cohort A and Cohort B, respectively. 3. Androgen-deprivation therapy (ADT, N=60): 30 subjects each for Cohort A and Cohort B, respectively 4. Systemic chemotherapy (Chemo, N=60): 30 subjects for Cohort A and Cohort B, respectively
Who may be able to join
- Subjects who have histopathologically confirmed prostate adenocarcinoma.
- Subjects who age 30 years to 100 years
- Subjects who agree to undergo the any of the following four treatments, including radical prostatectomy, definitive prostate radiotherapy, systemic chemotherapy, and androgen deprivation therapy for prostate cancer.
- Subjects who understand and will comply with the entire study procedures, consent to donate his spot urine (once for 50 ml) for urine metabolomics and proteomic profiling, and agree with subsequent collection and analysis of his clinical information including results of biopsy and the details of treatments and outcomes. (Note: Subjects will be told that the urine metabolomics and proteomics results will not be revealed to them.)
Who cannot join
- Subjects who have other cancers that have not been curatively treated or are disease-free for only 3 years or less. Subjects who have other genitourinary cancers (urothelial, renal cell, etc) are NOT allowed no matter what the disease-free duration is. However, subjects who have been curatively treated and are disease-free for 3 years or longer are allowed to be enrolled.
- Subjects who have severe organ function impairment which may significantly alter general cell metabolism or proteomics profiles determined by the investigators, such as Cre > 3.0, HbA1c > 9.0%, symptomatic heart failure, or other symptomatic metabolic diseases.
- Subjects who have significant infection or inflammation within 8 weeks of the biopsy.
- Subjects who are taking medicine(s) that may, deemed by the investigators, substantially affect cell metabolism and proteomics profiles.
- Subjects who have a life expectancy less than 12 months.
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, 100
Yeong-Shiau Pu Pu, MD PhD, 886-2-23123456 ext. 65254, pu5249@ntuh.gov.tw
Chung-Hsin Chen, MD PhD, 886-2-23123456 ext. 65242, mufasachen@gmail.com
About this study
Official title: Decipher the Biology of Lethal Prostate Cancer-Using Urine Metabolomics and Proteomics Profiling to Search for Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients
The study aims to identify potential urine marker metabolites as predictive or prognostic markers for treatment outcomes in patients with prostate cancer.
Read the detailed description
This is a single-center single-arm translational study where patients with prostate cancer who are about to receive definitive treatments will be invited to participate the study. After signing the approved informed consent, eligible and consenting subjects will donate their fresh urine samples for subsequent untargeted metabolomics and proteomics study to identify potential metabolite and protein markers that are able to predict responses (including efficacy and side effects) to definitive treatments. All subjects who have received varied treatment before the study can NOT be recruited.
- Conditions
- Prostate Cancer
- Being tested
- No intervention required
- Keywords
- prostate cancer, prostatectomy, prostate radiotherapy, chemotherapy, immunotherapy, biomarkers, metabolomics, proteomics, urine
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention requiredOther
No intervention required
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Ttaining chort will be recruited in the first 36 months of the study period to generate the first batch of urine metabolomic and proteomic profiles as predictive and prognostic markers. Receives: Other: No intervention required | |
| Cohort B | Validation cohort will be recruited in the next 24 months of the study period . Receives: Other: No intervention required |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical recurrence or progression
Measured: 5 years
toxicity profile, survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start11 Oct 2017
- Primary completion15 Jan 2027 (estimated)
- Study completion31 Jul 2031 (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 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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yeong-Shiau Pu, MD PhD, Principal investigator, Department of Urology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237026
- Sponsor's protocol ID
- 201705032RINA
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2017
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decipher the Biology of Lethal Prostate Cancer-Using Urine Metabolomics and Proteomics Profiling to Search for Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT03237026
- Acronym / sponsor ID
- 201705032RINA
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, prostatectomy, prostate radiotherapy, chemotherapy, immunotherapy, biomarkers, metabolomics, proteomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 31 Jul 2031 (estimated)
- First posted
- 2 Aug 2017 (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.
The study aims to identify potential urine marker metabolites as predictive or prognostic markers for treatment outcomes in patients with prostate cancer.
Detailed description
This is a single-center single-arm translational study where patients with prostate cancer who are about to receive definitive treatments will be invited to participate the study. After signing the approved informed consent, eligible and consenting subjects will donate their fresh urine samples for subsequent untargeted metabolomics and proteomics study to identify potential metabolite and protein markers that are able to predict responses (including efficacy and side effects) to definitive treatments. All subjects who have received varied treatment before the study can NOT be recruited.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Other: No intervention requiredTtaining chort will be recruited in the first 36 months of the study period to generate the first batch of urine metabolomic and proteomic profiles as predictive and prognostic markers. |
| Cohort B | – | Other: No intervention requiredValidation cohort will be recruited in the next 24 months of the study period . |
Who may qualify
- Ages
- 30 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A. Expected subject number to be enrolled: 360 men at NTUH. 1. Radical prostatectomy (OP, N=100): 50 subjects each for Cohort A and Cohort B, respectively. 2. Radiotherapy (RT, N=140): 70 subjects each for Cohort A and Cohort B, respectively. 3. Androgen-deprivation therapy (ADT, N=60): 30 subjects each for Cohort A and Cohort B, respectively 4. Systemic chemotherapy (Chemo, N=60): 30 subjects for Cohort A and Cohort B, respectively
Key inclusion criteria (4 listed)
- Subjects who have histopathologically confirmed prostate adenocarcinoma.
- Subjects who age 30 years to 100 years
- Subjects who agree to undergo the any of the following four treatments, including radical prostatectomy, definitive prostate radiotherapy, systemic chemotherapy, and androgen deprivation therapy for prostate cancer.
- Subjects who understand and will comply with the entire study procedures, consent to donate his spot urine (once for 50 ml) for urine metabolomics and proteomic profiling, and agree with subsequent collection and analysis of his clinical information including results of biopsy and the details of treatments and outcomes. (Note: Subjects will be told that the urine metabolomics and proteomics results will not be revealed to them.)
Key exclusion criteria (5 listed)
- Subjects who have other cancers that have not been curatively treated or are disease-free for only 3 years or less. Subjects who have other genitourinary cancers (urothelial, renal cell, etc) are NOT allowed no matter what the disease-free duration is. However, subjects who have been curatively treated and are disease-free for 3 years or longer are allowed to be enrolled.
- Subjects who have severe organ function impairment which may significantly alter general cell metabolism or proteomics profiles determined by the investigators, such as Cre > 3.0, HbA1c > 9.0%, symptomatic heart failure, or other symptomatic metabolic diseases.
- Subjects who have significant infection or inflammation within 8 weeks of the biopsy.
- Subjects who are taking medicine(s) that may, deemed by the investigators, substantially affect cell metabolism and proteomics profiles.
- Subjects who have a life expectancy less than 12 months.
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 |
|---|---|---|
| No intervention requiredNo intervention required | Other | Cohort A, Cohort B |
Primary outcome
Biochemical recurrence or progression
Time frame: 5 years
toxicity profile, survival
Time frame: 5 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 21 Sep 2026.
- 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, MD PhD principal investigator
Department of Urology, National Taiwan University Hospital
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 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 4 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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 Chung-Hsin Chen, MD PhD (886-2-23123456 ext. 65242, mufasachen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical recurrence or progression (time frame: 5 years). 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 21 Sep 2026.