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Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients

NCT ID: NCT03237026

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-11

Study Completion Date

2023-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Prostate Cancer

Keywords

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prostate cancer prostatectomy prostate radiotherapy chemotherapy immunotherapy biomarkers metabolomics proteomics urine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort A

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.

No intervention required

Intervention Type OTHER

No intervention required

Cohort B

Validation cohort will be recruited in the next 24 months of the study period .

No intervention required

Intervention Type OTHER

No intervention required

Interventions

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No intervention required

No intervention required

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yeong-Shiau Pu, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, National Taiwan University Hospital

Locations

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National Taiwan University

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chung-Hsin Chen, MD PhD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Yeong-Shiau Pu, MD PhD

Role: CONTACT

Phone: 886-2-23123456

Email: [email protected]

Facility Contacts

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Yeong-Shiau Pu Pu, MD PhD

Role: primary

Chung-Hsin Chen, MD PhD

Role: backup

Other Identifiers

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201705032RINA

Identifier Type: -

Identifier Source: org_study_id