About this trial
The study aims to identify potential urine marker metabolites as predictive or prognostic markers for treatment outcomes in patients with prostate cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.)
Disqualifiers
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.
Trial 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
Trial design
Cohort
Prospective
Treatments tested in this trial
No intervention required
Other interventionNo intervention required
Treatment groups
Trial outcomes
Primary outcomes
Biochemical recurrence or progression
toxicity profile, survival
Sponsors and contacts
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