Identify Genes/Pathways Responsible for Progression From Low Risk to Higher Risk Prostate Cancer

NCT03789253 | Recruiting

• 1 other identifier: 201712093RINB
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

In Taiwan, about 70% of new incident prostate cancer patients have localized disease. Most patients were detected by PSA screening. Among them, many had low-risk PC, which is very likely latent in nature, progresses slowly, and rarely leads to death. Most patients died of other causes, such as other cancers, cardiovascular diseases, and diabetes mellitus. Many guidelines recommend that active surveillance (AS) or watchful waiting (WW) is a good option for low risk patients to avoid overtreatment-related complications. However, 30% of patients on AS will finally need definitive treatments due to disease progression within 10 years. We hypothesize that there are differential gene expressions between progressive and non-progressive tumors. If we can identify key genes or pathways that are responsible for progression of low risk PC to higher risk diseases, PC progression could be reduced substantially by regulating these genes or pathways and maintain long-term cancer latency to control non-metastatic PC. In light of the high prevalence rate of latent PC in adult men, the strategy is in fact the best strategy for preventing clinical PC.

Conditions

Prostate Cancer Stage I

Keywords

active surveillance, microarray, latent, GSEA, latent

Outcome Measures

Primary Outcomes (1)

• Gene expression

  Using GESA analysis

  3 years

Study Arms (2)

AS cohort with progression

AS cohort with tumor progression

AS cohort without progression

AS cohort without tumor progression

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Low or intermediate risk prostate cancer patients receiving active surveillance

You may qualify if:

• Historically or cytologically confirmed adenocarcinoma of prostate.
• Have or ever received active Surveillance as the main conservative management at NTUH (National Taiwan University Hospital).
• Have or will receive prostate biopsy to confirm tumor progression after the diagnosis of prostate cancer.

You may not qualify if:

• Have received systemic chemotherapy, pelvic radiotherapy or androgen deprivation therapy (ADT) before the obtainment of pathological specimen from prostate operation or biopsy.
• Subjects who disagree with signing the informed consent.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University

Taipei, 10002, 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, PhD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeong-Shiau Pu, PhD

CONTACT

886-2-23123456; yspu@ntu.edu.tw

Chung-Hsin Chen, PhD

CONTACT

886-2-23123456; mufasachen@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: December 28, 2018
• Study Start: January 2, 2019
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: August 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)