Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention required.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: 30 years — 100 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Decipher the Biology of Lethal Prostate Cancer-Using Urine Metabolomics and Proteomics Profiling to Search for Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients
Overview
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.
Interventions
- Other No intervention required
No intervention required
Primary outcome measures
- Biochemical recurrence or progression [Time frame: 5 years]
- toxicity profile, survival [Time frame: 5 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Taiwan · 1 center
- National Taiwan University — Taipei
Identifiers
NCT: NCT03237026 · 201705032RINA