Spermine Measuring Device Evaluation Protocol

NCT04339920 | Withdrawn

• 1 other identifier: CRE 2020.050
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate gland is a clinically important male sexual organ and its main function is for the production of semen. Globally, it is the second most common cancer in men globally and is also the fifth cancer cause for death in male. Despite the improvement in the understanding of prostate cancer, the current usage of serum prostate specific antigen (PSA) as a diagnostic marker is still not ideal. Many patients with elevated PSA and then subjected to prostate biopsy were found to have no prostate cancer. Therefore, there is a need to discover new biological markers to improve the current situation in diagnosis and also management of prostate cancer. In our recent studies, urinary spermine levels have been shown to correlate well with prostate cancer diagnosis and cancer aggressiveness. Due to its nature, it could provide a more convenient and non-invasive method for detecting prostate cancer. In order to further improve the accessibility of the test, a simple urine measuring device has been designed to allow more simple and practical usage of the test in clinical setting.The purpose of this study was to evaluate the accuracy of this newly designed urine measuring device for urinary spermine in predicting your prostatic biopsy result.

Conditions

Prostate Cancer

Keywords

Urinary spermine; Prostate cancer

Outcome Measures

Primary Outcomes (1)

• Correlation of the Spermine measuring device and final prostate biopsy results.

  By comparing the urine spermine level results of the spermine measuring device with the prostate biopsy pathology

  At baseline

Secondary Outcomes (1)

• Accuracy of the Spermine measuring device in measuring the urine spermine level

  At baseline

Study Arms (1)

Chinese patients with clinical suspicious of prostate cancer

Chinese patients with clinical suspicious of prostate cancer, due to elevated serum PSA or abnormal digital rectal examination, will be recruited for the study from the Prince of Wales Hospital and North District Hospital.

Diagnostic Test: Spermine Measuring Device

Interventions

Spermine Measuring Device DIAGNOSTIC_TEST

The Spermine Measuring Device (SMD) is a simple device, with automatic urine aspiration and also spermine level assessment. First about 30 cc urine will be freshly collected by a prepared collection device. Then the cap of the SMD will be removed and the aspiration tip of the device will be immersed into the urine specimen. After firmly pressed on the device, a small sample of urine will be aspirated into the SMD. The device will then automatically assess the urine spermine level. The result will then be read at a indicator window after about 5 minutes. If the level was below a pre-set cutoff, i.e. suggestive of having increase risk of prostate cancer, the indicator window will turn into red colour. However, if the spermine level is higher than the cutoff value, i.e. low risk of having cancer, the indicator window will turn blue.

Chinese patients with clinical suspicious of prostate cancer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Prostate can only be found in male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese patients with clinical suspicious of prostate cancer, due to elevated serum PSA or abnormal digital rectal examination, will be recruited for the study from the Prince of Wales Hospital and North District Hospital.

You may qualify if:

• Adult Chinese male patients with age \> 18 years old
• Clinical indicated for prostate cancer detection and has serum PSA level done within 8 weeks of urine test.

You may not qualify if:

• Patient with recent urinary tract infection within 6 weeks prior to urine collection.
• Patient with recent urethral instrumentation, such as Foley catheter insertion, cystoscopy etc., within 6 weeks prior to urine collection.
• Patient with consumption of 5 alpha reductase inhibitors in past 6 months.
• Patient refused or unable to provide consent for the study

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

Related Publications (8)

• Hong Kong Cancer registry 2017.

  BACKGROUND

• Wong HF, Yee CH, Teoh JY, Chan SY, Chiu PK, Cheung HY, Hou SS, Ng CF. Time trend and characteristics of prostate cancer diagnosed in Hong Kong (China) in the past two decades. Asian J Androl. 2019 Jan 1;21(1):104-106. doi: 10.4103/aja.aja_75_18. No abstract available.

  PMID: 30178778 BACKGROUND

• Russell DH. Increased polyamine concentrations in the urine of human cancer patients. Nat New Biol. 1971 Sep 29;233(39):144-5. doi: 10.1038/newbio233144a0. No abstract available.

  PMID: 5286749 BACKGROUND

• Lee SH, Yang YJ, Kim KM, Chung BC. Altered urinary profiles of polyamines and endogenous steroids in patients with benign cervical disease and cervical cancer. Cancer Lett. 2003 Nov 25;201(2):121-31. doi: 10.1016/s0304-3835(03)00014-4.

  PMID: 14607325 BACKGROUND

• Loser C, Folsch UR, Paprotny C, Creutzfeldt W. Polyamines in colorectal cancer. Evaluation of polyamine concentrations in the colon tissue, serum, and urine of 50 patients with colorectal cancer. Cancer. 1990 Feb 15;65(4):958-66. doi: 10.1002/1097-0142(19900215)65:43.0.co;2-z.

  PMID: 2297664 BACKGROUND

• Leveque J, Foucher F, Bansard JY, Havouis R, Grall JY, Moulinoux JP. Polyamine profiles in tumor, normal tissue of the homologous breast, blood, and urine of breast cancer sufferers. Breast Cancer Res Treat. 2000 Mar;60(2):99-105. doi: 10.1023/a:1006319818530.

  PMID: 10845272 BACKGROUND

• Tsoi TH, Chan CF, Chan WL, Chiu KF, Wong WT, Ng CF, Wong KL. Urinary Polyamines: A Pilot Study on Their Roles as Prostate Cancer Detection Biomarkers. PLoS One. 2016 Sep 6;11(9):e0162217. doi: 10.1371/journal.pone.0162217. eCollection 2016.

  PMID: 27598335 BACKGROUND

• Chiu PKF, Tsoi TH, Wong YP, Teoh JYC, Lo KL, Ng CF, Wong KL. The novel urine Spermine test predicts prostate cancer: the first prospective evaluation. (Accepted poster presentation in EAU 2020)

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum PSA level will be collected. Up to 100cc of urine will be freshly collected from patient before they undergo prostate biopsy.

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: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 9, 2020
• Study Start: September 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 4, 2022

Record last verified: 2021-12

Locations

HK (1)