Decipher Lethal Prostate Cancer Biology - Urine Metabolomics

NCT03237702 | Recruiting

• 1 other identifier: 201705040MIPB
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

Through a better understanding of the biology of significant (lethal) prostate cancer, we hope to develop new markers/targets from urine metabolomics for more effective screening and prevention of significant prostate cancer. In the meantime, with these new markers we may substantially reduce overtreatment of insignificant PC.

Conditions

Significant Prostate Cancer

Keywords

prostate cancer; prostate biopsy; biomarkers; metabolomics; overtreatment; cancer screening; urine; lycopene; proteomics; urine omics

Outcome Measures

Primary Outcomes (1)

• Change of urine metabolomics

  Observe the change of metabolomics in urine samples collected before and upon the completeness of MCS supplementation

  8 weeks

Study Arms (1)

MCS arm

EXPERIMENTAL

The participants who will have Multi-Carotenoids for 8 weeks The intervention is Multi-Carotenoids 30 mg for 8 weeks.

Dietary Supplement: Multi-Carotenoids

Interventions

Multi-Carotenoids DIETARY_SUPPLEMENT

All participants in the second stage will receive multi-carotenoids 30 mg qd for 8 weeks.

MCS arm

Eligibility Criteria

• Age: 30 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have planned to undergo prostate biopsy or have completed biopsy before 6 weeks.
• Subjects who are aged between 30 and 100 years men.
• For subjects who are prostate cancer patients for rebiopsy, the testosterone level should be within normal limit (testosterone \>1.5 ng/ml).
• Subjects who understand the entire study procedures and consent to donate his spot urine (once for 50 ml) and agree with subsequent analyses of his clinical information including biopsy results, treatments and outcomes. (Note: Subjects will be told that the urine metabolomics results will not be revealed to them.)

You may not qualify if:

• Subjects who have other active cancers. However, subjects who have cancers that have been curatively treated and who 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 determined by the investigators, such as or Cre \> 3.0, HbA1c \> 9.0%, symptomatic heart failure, or other symptomatic metabolic diseases.
• Subjects who are receiving or have received systemic therapy, such as chemotherapy, androgen deprivation therapy (ADT), immunotherapy, or targeted therapy within 3 months of the screening.
• Subjects who have been treated with pelvic radiotherapy within 3 months of the screening.
• Subjects who have significant infection or inflammation within 8 weeks of the biopsy.
• Subjects who have pyuria (defined as \> 5 WBC/HPF) of urinalysis results within 4 weeks of the biopsy
• Topical or oral prednisolone equivalent dosage larger 10 mg per day for 14 days or more.
• The last dose of prednisolone is within 4 weeks of the biopsy.
• Subjects who have a life expectancy less than 12 months.
• Subjects who use MCS or found supplementation containing large amount of lycopene in recent 60 days or less. The definition of large amount of lycopene is more than 2 mg per day.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Taipei Medical University Hospital: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator
• Cardinal Tien Hospital: collaborator
• Taipei Medical University Shuang Ho Hospital: collaborator
• Far Eastern Memorial Hospital: collaborator
• Taichung Tzu Chi Hospital: collaborator
• Shin Kong Wu Ho-Su Memorial Hospital: collaborator
• Chang Gung Memorial Hospital: collaborator

Study Sites (1)

Department of Urology, National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Yeong-Shiau Pu, MD PhD

  Department of Urology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chung-Hsin Chen, MD PhD

CONTACT

+886-23123456; mufasachen@gmail.com

Yeong-Shiau Pu, MD PhD

CONTACT

+886-23123456; pu5249@ntuh.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 1,980 male patients who are planning to have prostate biopsy will be enrolled in the first stage of this study for measuring urine metabolomics. Only the patients who have non-metastatic significant prostate cancer, insignificant prostate cancer, ASAP/PIN, or benign prostate proved by prostate biopsy are enrolled into the second stage in which MCS supplementation will be used for 8 weeks. In addition, 20 men and 20 women will be enrolled as a healthy control without any further medication.

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 2, 2017
• Study Start: August 1, 2017
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)