Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients

• Conditions: Prostate Cancer
• Interventions: Other: No intervention required

• Registration Number: NCT03237026
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study First Submitted: 2017-07-30
• Study First Submitted QC: 2017-07-30
• Study First Posted: 2017-08-02
• Study Start: 2017-10-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-11-29
• Last Update Posted: 2020-12-01
• Primary Completion: 2021-07-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 360

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

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort A	No intervention required	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.
Cohort B	No intervention required	Validation cohort will be recruited in the next 24 months of the study period .

Primary Outcome Measures

Name	Time	Method
toxicity profile, survival	5 years
Biochemical recurrence or progression	5 years

Trial Locations

Locations (1)

National Taiwan University; 🇨🇳 Taipei, Taiwan