Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03237026
• Other study ID #: 201705032RINA
• Status: Recruiting
• Start date: October 11, 2017
• Est. completion date: July 31, 2023

Study information

• Verified date: March 2020
• Source: National Taiwan University Hospital
• Contact: Chung-Hsin Chen, MD PhD
• Phone: 886-2-23123456
• Email: mufasachen[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims to identify potential urine marker metabolites as predictive or prognostic markers for treatment outcomes in patients with prostate cancer.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• No intervention required
No intervention required

Locations

Country	Name	City	State
Taiwan	National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical recurrence or progression		5 years
Primary	toxicity profile, survival		5 years