Exosomal microRNA in Predicting the Aggressiveness of Prostate Cancer in Chinese Patients

NCT03911999 | Completed

• 1 other identifier: CRE-2018.063
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The prostate gland is a clinically important male accessory sex gland and vital for its production of semen. Prostate cancer (PCa) is now ranked 3th in annual incidence of male cancer and ranked 5th for cancer-related death in men in Hong Kong which accounts for about 10.9 deaths per 100,000 persons. Its incidence is rising rapidly, almost tripled in the past 10 years. Fortunately, with the improvement in awareness of the disease and also increasing use of serum prostate specific antigen for early case identification, many patients are diagnosed at an earlier stage. However, unlike other malignancy, PCa is characterized by its slow progression nature. Therefore, some patients with low grade low volume disease might never suffered from PCa related complications or mortality. As a result, recent year, there is an increase use a more conservative approach, active surveillance (AS), for management of early prostate cancer. The principle of AS is selecting patients with low risk of disease and offered them regular monitoring, instead of radical local therapy, unless patient's cancer was noticed to progressing. By using this approach, patients might avoid possible complications related to treatment. Currently, people could use some clinical parameters, imaging and repeated prostate biopsy to assess and monitor the aggressiveness/ progression of PCa. However, these parameters suffered from defects, such as low correlation to the final PCa pathology or not readily repeatable for patients. Therefore, there is a need to identify more easy, safe and repeatable monitoring of the aggressiveness of prostate cancer. Exosome is genetic materials secreted by cells and could be measured in various body fluid. There are some studies suggested it is a potential marker for PCa diagnosis and monitoring. The aim of this study is to investigate the relationship of urinary exosome and the aggressiveness of prostate cancer.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• To compare the differences in microRNA expression between non-prostate cancer subjects, pathologically insignificant and significant prostate cancer patients.

  Urine will be collected prior to surgery. The urine sample will then be handled immediately for exosomal RNA extraction (refer to specific methodology). The extracted exosomal RNA would then be stored for next generation sequencing (NGS). Results of the 3 groups will then be compared, with reference to literatures findings. Candidate microRNAs that can differentiate between pathologically significant and insignificant cancer will be selected for Part II study.

  Baseline, one-time point

• To assess the accuracy of selected microRNAs for the differentiation of patients with pathologically insignificant and significant prostate cancer after radical prostatectomy

  Urine will be collected prior to surgery. The urine sample will then be handled immediately for exosomal RNA extraction (refer to specific methodology). The extracted exosomal RNA would then be stored for next generation sequencing (NGS). Results of the 3 groups will then be compared, with reference to literatures findings. Candidate microRNAs that can differentiate betten pathologically significant and insignificant cancer will be selected for Part II study.The preoperative patients and disease parameters, including age, clinical staging, serum PSA level, prostatic biopsy results, MRI findings, together with the prostatectomy pathology will be collected for subsequent data analysis.

  Baseline, one-time point

Study Arms (3)

Non-prostate cancer subjects

No clinical evidence of prostate cancer

Subjects with pathologically insignificant prostate cancer

Insignificant prostate cancers were organ confined with tumor volumes less than 0.5 cc and Gleason score \< 7.

Subjects with pathologically significant prostate cancer

Significant cancers are those with either Gleason score \> 7, evidences of extra-prostatic extension with positive margins, or seminal vesicles / lymph nodes involvement.

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

For non prostate cancer group, there is no specific time limit for urine collection. For prostate cancer group, urine will be collected prior to prostatectomy.

You may qualify if:

• For non prostate cancer group
• Male subject with age 45 or above
• No clinical evidence of PCa, serum PSA \<4 ng/dl and normal digital rectal examination.
• For prostate cancer group
• Male subject with age 45 or above
• Clinically diagnosed to have localized PCa and planned for radical prostatectomy
• No prior systemic therapy for PCa used, including hormonal or chemotherapy.

You may not qualify if:

• History of medications usage that can affect serum PSA levels within 6 months of study enrolment.
• History of active urinary tract infection within 1 month of study enrolment.
• History of invasive prostate / bladder treatments within 6 months of study enrolment.
• History of concurrent renal/bladder cancer within 6 months of study enrolment.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (18)

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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

• Chi Fai Ng, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 11, 2019
• Study Start: May 3, 2018
• Primary Completion: November 15, 2020
• Study Completion: December 31, 2020
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

HK (1)