Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients

NCT03237026 | Recruiting

• 1 other identifier: 201705032RINA
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to identify potential urine marker metabolites as predictive or prognostic markers for treatment outcomes in patients with prostate cancer.

Conditions

Prostate Cancer

Keywords

prostate cancer; prostatectomy; prostate radiotherapy; chemotherapy; immunotherapy; biomarkers; metabolomics; proteomics; urine

Outcome Measures

Primary Outcomes (2)

• Biochemical recurrence or progression

  5 years

• toxicity profile, survival

  5 years

Study Arms (2)

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

No intervention required OTHER

No intervention required

Cohort A; Cohort B

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University

Taipei, 100, Taiwan

RECRUITING

Biospecimen

fresh urine samples

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Yeong-Shiau Pu, MD PhD

  Department of Urology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chung-Hsin Chen, MD PhD

CONTACT

886-2-23123456; mufasachen@gmail.com

Yeong-Shiau Pu, MD PhD

CONTACT

886-2-23123456; pu5249@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2017
• First Posted: August 2, 2017
• Study Start: October 11, 2017
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): July 31, 2031
• Last Updated: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)