Prostate CancerNCT04339920
Spermine Measuring Device Evaluation Protocol
An observational study of Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Spermine Measuring Device
- How many people
- 0 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2021to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Performance of a Urine Spermine Measuring Device in Predicting Prostate Biopsy Result
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.
Read the detailed description
Prostate cancer (PC) is highly prevalent worldwide and is currently the 3rd most commonly diagnosed prostate cancer in Hong Kong male population with more than 2000 new cases diagnosed per year. Depending on the clinical staging and also the patients' condition, different treatments, including curative surgery or radiotherapy, palliative androgen deprivation therapy, could be offered to patients and will good response. However, current there are only one biological marker, PSA, for the monitoring of the disease progress and treatment response. While PSA testing provided a reasonable assessment of the disease status and progress, it is an invasive blood test and maybe less convenience for some patients. Therefore, there is a need for exploring newer markers for the monitoring of the treatment response and disease progress is needed.
One example of such cancer biomarkers are natural polyamines. Interests on these analytes have been starting in 1971 when Russell reported a considerable increase of urinary polyamines such as putrescine (Put), spermidine (Spd) and spermine (Spm) in patients with various types of solid tumors and leukaemias. Afterwards, polyamine studies focusing on specific cancers continued, like cervical cancer, colorectal cancer and breast cancer, etc.
In our recent study, we have explored the potential roles of urinary polyamines as prostate cancer biomarkers were evaluated. Patients with prostate cancer (PCa), benign prostatic hyperplasia (BPH) patients and healthy controls (HC) showing PSA>4.0ng/ml were enrolled in the study. Their urine samples were obtained, and the urinary levels of Put, Spd, Spm were determined by ultra-high-performance liquid chromatography coupled with triple quadrupole mass spectrometer (UPLC-MS/MS). Receiver operating characteristics (ROC) curve and Student's t- test were used to evaluate their diagnostic accuracies. Among the three biogenic polyamines, Spm had demonstrated a good diagnostic performance when comparing their levels in PCa patients with BPH patients (1.47 in PCa vs 5.87 in BPH; p<0.0001). The results were in accordance with transrectal ultrasound prostatic biopsy (TRUSPB) results, with an area under curve (AUC) value of 0.83±0.03. Therefore, urinary Spm could have a potential to serve as a novel PCa diagnostic biomarker, which in turn could help to address the limited sensitivity and specificity problem of serum PSA test. In our further work, we have confirmed that spermine is a good marker for the detection of prostate cancer and also showed good correlation with cancer grading.
However, the current measurement of spermine required the use of liquid chromatography (LCM) in laboratory, which might limit its clinical usage. Therefore, a simple spermine measuring device (SMD) has been designed for easier daily usage, such as simple cancer screening and also combined evaluation with serum PSA level. The 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. However, the kit has not been validated in clinical urine sample. Therefore, we would like to perform an evaluation the accuracy of this SMD with the laboratory measured spermine level by LCM, as well as the pathology result from prostate biopsy.
- Conditions
- Prostate Cancer
- Being tested
- Spermine Measuring Device
- Keywords
- Urinary spermine, Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spermine Measuring DeviceDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Spermine Measuring Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline
Secondary outcomes (1)
Accuracy of the Spermine measuring device in measuring the urine spermine level
By comparing the urine spermine level results of the spermine measuring device with that of the liquid chromatography
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start1 Sep 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi Fai NG, Chinese University of Hong Kong
- Investigators
- Chi Fai NG, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04339920
- Sponsor's protocol ID
- CRE 2020.050
- Status last verified
- Dec 2021
- First submitted
- 2 Apr 2020
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hong Kong Cancer registry 2017.
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.
PubMed 30178778Russell 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.
PubMed 5286749Lee 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.
PubMed 14607325Loser 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.
PubMed 2297664Leveque 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.
PubMed 10845272Tsoi 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.
PubMed 27598335Chiu 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)
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Performance of a Urine Spermine Measuring Device in Predicting Prostate Biopsy Result
- ClinicalTrials.gov ID
- NCT04339920
- Acronym / sponsor ID
- CRE 2020.050
- Conditions
- Prostate Cancer
- Keywords
- Urinary spermine, Prostate cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prostate cancer (PC) is highly prevalent worldwide and is currently the 3rd most commonly diagnosed prostate cancer in Hong Kong male population with more than 2000 new cases diagnosed per year. Depending on the clinical staging and also the patients' condition, different treatments, including curative surgery or radiotherapy, palliative androgen deprivation therapy, could be offered to patients and will good response. However, current there are only one biological marker, PSA, for the monitoring of the disease progress and treatment response. While PSA testing provided a reasonable assessment of the disease status and progress, it is an invasive blood test and maybe less convenience for some patients. Therefore, there is a need for exploring newer markers for the monitoring of the treatment response and disease progress is needed.
One example of such cancer biomarkers are natural polyamines. Interests on these analytes have been starting in 1971 when Russell reported a considerable increase of urinary polyamines such as putrescine (Put), spermidine (Spd) and spermine (Spm) in patients with various types of solid tumors and leukaemias. Afterwards, polyamine studies focusing on specific cancers continued, like cervical cancer, colorectal cancer and breast cancer, etc.
In our recent study, we have explored the potential roles of urinary polyamines as prostate cancer biomarkers were evaluated. Patients with prostate cancer (PCa), benign prostatic hyperplasia (BPH) patients and healthy controls (HC) showing PSA>4.0ng/ml were enrolled in the study. Their urine samples were obtained, and the urinary levels of Put, Spd, Spm were determined by ultra-high-performance liquid chromatography coupled with triple quadrupole mass spectrometer (UPLC-MS/MS). Receiver operating characteristics (ROC) curve and Student's t- test were used to evaluate their diagnostic accuracies. Among the three biogenic polyamines, Spm had demonstrated a good diagnostic performance when comparing their levels in PCa patients with BPH patients (1.47 in PCa vs 5.87 in BPH; p<0.0001). The results were in accordance with transrectal ultrasound prostatic biopsy (TRUSPB) results, with an area under curve (AUC) value of 0.83±0.03. Therefore, urinary Spm could have a potential to serve as a novel PCa diagnostic biomarker, which in turn could help to address the limited sensitivity and specificity problem of serum PSA test. In our further work, we have confirmed that spermine is a good marker for the detection of prostate cancer and also showed good correlation with cancer grading.
However, the current measurement of spermine required the use of liquid chromatography (LCM) in laboratory, which might limit its clinical usage. Therefore, a simple spermine measuring device (SMD) has been designed for easier daily usage, such as simple cancer screening and also combined evaluation with serum PSA level. The 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. However, the kit has not been validated in clinical urine sample. Therefore, we would like to perform an evaluation the accuracy of this SMD with the laboratory measured spermine level by LCM, as well as the pathology result from prostate biopsy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese patients with clinical suspicious of prostate cancer | – | Diagnostic Test: Spermine Measuring DeviceChinese 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spermine Measuring DeviceThe 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. | Diagnostic test | Chinese patients with clinical suspicious of prostate cancer |
Primary outcome
Correlation of the Spermine measuring device and final prostate biopsy results.
Time frame: At baseline
By comparing the urine spermine level results of the spermine measuring device with the prostate biopsy pathology
1 secondary outcome
Accuracy of the Spermine measuring device in measuring the urine spermine level
Time frame: At baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- BackgroundHong Kong Cancer registry 2017.
- Background: PubMed 30178778Wong 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.
- Background: PubMed 5286749Russell 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.
- Background: PubMed 14607325Lee 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.
- Background: PubMed 2297664Loser 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.
- Background: PubMed 10845272Leveque 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.
- Background: PubMed 27598335Tsoi 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.
- BackgroundChiu 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Fai NG, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of the Spermine measuring device and final prostate biopsy results. (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04339920, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.