Predictive and Prognostic Markers for Treatment Outcomes... | NCT03237026

Studies
Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients

NCT03237026

Sponsor

National Taiwan University Hospital

Status

Recruiting

Last Update Posted

Jan 20, 2026Actual

Enrollment

360Estimated

Phase

Not provided

Conditions

Prostate Cancer

Interventions

No intervention required

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 11, 2017Actual

Primary Completion Date

Jan 15, 2027Estimated

Completion Date

Jul 31, 2031Estimated

First Submitted Date

Jul 30, 2017

First Submission Date that Met QC Criteria

Jul 30, 2017

First Posted Date

Aug 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2026

Last Update Posted Date

Jan 20, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Not provided

Description

Enrollment

360Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
No intervention required	Other	No intervention required	Cohort A Cohort B

Measure	Description	Time Frame
Biochemical recurrence or progression		5 years
toxicity profile, survival		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.)

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

A. Expected subject number to be enrolled: 360 men at NTUH.

Radical prostatectomy (OP, N=100): 50 subjects each for Cohort A and Cohort B, respectively.
Radiotherapy (RT, N=140): 70 subjects each for Cohort A and Cohort B, respectively.
Androgen-deprivation therapy (ADT, N=60): 30 subjects each for Cohort A and Cohort B, respectively
Systemic chemotherapy (Chemo, N=60): 30 subjects for Cohort A and Cohort B, respectively

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Chung-Hsin Chen, MD PhD	Contact	886-2-23123456	65242	mufasachen@gmail.com
Yeong-Shiau Pu, MD PhD	Contact	886-2-23123456	65254	pu5249@ntuh.gov.tw

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms