CClinicalTrials.gg
RecruitingNCT03237026Updated Sep 21, 2026

Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients

An observational study in Prostate Cancer, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to male participants aged 30 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by National Taiwan University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
360
Ages
30 Years to 100 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Prostate Cancer

Browse trials for

Keywords

  • prostate cancer
  • prostatectomy
  • prostate radiotherapy
  • chemotherapy
  • immunotherapy
  • biomarkers
  • metabolomics
  • proteomics
  • urine
03

Who can participate

Ages eligible
30 Years to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Probability sample

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

Inclusion criteria

  1. Subjects who have histopathologically confirmed prostate adenocarcinoma.
  2. Subjects who age 30 years to 100 years
  3. 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.
  4. 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.)

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. 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.
  3. Subjects who have significant infection or inflammation within 8 weeks of the biopsy.
  4. Subjects who are taking medicine(s) that may, deemed by the investigators, substantially affect cell metabolism and proteomics profiles.
  5. Subjects who have a life expectancy less than 12 months.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
360 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Other: No intervention required

  • Cohort B

    Validation cohort will be recruited in the next 24 months of the study period .

    Other: No intervention required

Interventions

  • OtherNo intervention required

    No intervention required

05

What researchers measure

Primary outcomes

  1. Biochemical recurrence or progression

    Time frame: 5 years

  2. toxicity profile, survival

    Time frame: 5 years

06

Study locations

1 of 1 sites recruiting
  • National Taiwan University
    Taipei, 100, Taiwan
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03237026
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Aug 2, 2017
Start date
Oct 11, 2017
Primary completion
Jan 15, 2027 (estimated)
Completion
Jul 31, 2031 (estimated)
Last update
Sep 21, 2026

Study contacts

Chung-Hsin Chen, MD PhD
Contact
mufasachen@gmail.com
886-2-23123456 ext. 65242
Yeong-Shiau Pu, MD PhD
Contact
pu5249@ntuh.gov.tw
886-2-23123456 ext. 65254
Yeong-Shiau Pu, MD PhD
principal investigator · Department of Urology, National Taiwan University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion