Clinical trial · Observational
Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients
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
NCT03237026CI-TRIAL-00101104recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
The study aims to identify potential urine marker metabolites as predictive or prognostic markers for treatment outcomes in patients with prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention required | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cohort A
- description
- 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.
- interventionNames
- Other: No intervention required
- label
- Cohort B
- description
- Validation cohort will be recruited in the next 24 months of the study period .
- interventionNames
- Other: No intervention required
Primary outcomes (2)
- measure
- Biochemical recurrence or progression
- timeFrame
- 5 years
- measure
- toxicity profile, survival
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 30 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.