Predictive and Prognostic Markers for Treatment Outcomes in Prostate Cancer Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age30-100
SponsorNational Taiwan University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.)

Disqualifiers

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.

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • No intervention required

    Other intervention

    No intervention required

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: Cohort A1 intervention
Group B: Cohort B1 intervention

Trial outcomes

Primary outcomes

1

Biochemical recurrence or progression

Time frame
5 years
2

toxicity profile, survival

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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