Clinical trial NCT03237026: Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: prostate cancer
prostatectomy
prostate radiotherapy
chemotherapy
immunotherapy
biomarkers
metabolomics
proteomics
urine
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 360
Sex: MALE
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biochemical recurrence or progression
timeFrame: 5 years
measure: toxicity profile, survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
affiliation: Department of Urology, National Taiwan University Hospital
name: Yeong-Shiau Pu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: