Status:
UNKNOWN
Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
30-100 years
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 ap...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 11 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2023
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT03237026
Start Date
October 11 2017
End Date
July 31 2023
Last Update
December 1 2020
Active Locations (1)
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1
National Taiwan University
Taipei, Taiwan, 100