Prostate CancerNCT03888742
The Effect of Androgen Deprivation Therapy on Gut and Urinary Microbiota in Patients With Prostate Cancer
An observational study of Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The incidence of prostate cancer is increasing in Hong Kong, as well as that of recurrent or metastatic prostate cancer. Androgen deprivation therapy (ADT) is the standard treatment for recurrent or metastatic prostate cancer, with side effects such as obesity, type 2 diabetes mellitus, metabolic syndrome… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 214 participants
- Where
- 1 siteHong Kong
- Study dates
- 12 Nov 2018to 7 Jun 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: 300 Patients (150 patients with ADT usage and 150 patients with radical prostatectomy done) who fulfilled the above inclusion criteria with no exclusion criteria will be recruited for the study.
Who may be able to join
- Adult patients with age greater than or equal to 18 years old, who are able to provide consent
- Patients who was diagnosed to have prostate cancer
- Patients either received continue ADT treatment for at least more than 6 months or have radical prostatectomy performed more than 6 months ago.
Who cannot join
- Recent use of antibiotics within one month
- History of urinary tract infection in preceding year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross Sectional Study to Assess the Effect of Androgen Deprivation Therapy on Gut and Urinary Microbiota in Patients With Prostate Cancer
The incidence of prostate cancer is increasing in Hong Kong, as well as that of recurrent or metastatic prostate cancer. Androgen deprivation therapy (ADT) is the standard treatment for recurrent or metastatic prostate cancer, with side effects such as obesity, type 2 diabetes mellitus, metabolic syndrome, osteoporosis and cognitive impairment. With the improvement of treatment, the 5-year survival rate of recurrent and metastatic prostate cancer is up to 20%, and therefore increases the chances of developing such side effects.
Due to the introduction of next generation sequencing, investigators have more knowledge of the microbiota in our body, particularly the gut microbiota. Different studies have related gut dysbiosis with obesity, type 2 diabetes mellitus and metabolic syndrome. If investigators can show that ADT is leading to gut dysbiosis, this could be a way in preventing or treating the side effects of ADT.
This study aims to identify whether ADT in patients with prostate cancer will have different composition in their gut and urine microbiota.
Read the detailed description
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. (Hong Kong Cancer registry 2015) Its incidence is rising rapidly, almost tripled in the past 10 years. As the elderly population continues to increase, the impact of PCa on the men's health and also the burden on health care system will continue to rise.
Despite the improvement in awareness of the disease and also increasing use of serum prostate specific antigen, many patients still presented at a late stage that beyond cure by local therapy. Together with those patients suffered recurrent disease after local therapy,1 many PCa patients required the use of androgen deprivation therapy (ADT) for the control of disease.
However, unlike other malignancy, PCa is characterized by its slow progression nature and even for metastatic disease the 5-year survival is upto 20%. Therefore, while ADT can provide effective control of disease, there are increasing evidences suggesting that it can also result in many adverse effects in the patients, and these effects are particular important due to the long survival of these patients. From the western literature, the adverse effects can be quite diverse.2 Classical side effects after ADT include mood changes, hot flushes, change in cognitive function,3 loss of libido, erectile dysfunction, osteoporosis and pathological fracture.4 Also there are more and more evidences showed ADT will also altered the metabolic and cardiovascular status of the patients and resulted in increase in insulin resistance and increase in risk of cardiovascular related mortality.5-7 Similarly, from our local data, investigators also observed similar increase in adverse events also happened in Chinese patients treated with ADT.8
There are many possible mechanisms proposed for the occurrence of these adverse events in patients receiving ADT, including increase in obesity, dyslipidaemia, insulin resistance etc. All these factors will lead to increase in metabolic and cardiovascular risk. However, the exact link between of hypogonadism and the development of obesity, dyslipidaemia and insulin resistance was still unclear.
Since the development of the next-generation sequencing, the knowledge of the microbiota in different sites made much progress. Of all other sites, the gut was the most frequently studied. It was found that a number of different conditions were associated with the composition of the gut microbiota, like age9, environmental factors (e.g. diet10-12), medications and diseases like obesity13, inflammatory bowel disease14 and colorectal cancer.15 Other than those mentioned, gender difference in gut microbiota was found in animal studies16 as well as human studies.17-20
On the other hand, urinary microbiota was also found to have gender differences21. The mechanism of this difference is proposed by animal studies to be related to sex hormone16,22, and it was proposed to be due to the hormone-microbe interaction, or due to the sex-specific immune response.23
Recent studies has suggested castration will affect the guts microflora and resulted in the development of obesity in mice.22 However, whether similar effect in human was unknown. Moreover, if the microflora in men was also changed by ADT, this might be one of the underlying mechanism for the increase in cardiovascular and metabolic risk observed in men receiving ADT. Therefore, investigators would like to perform a prospective study to examine the relationship between ADT and gut and urinary microbiota, and also the possible relationship with the development of metabolic and cardiovascular complications in our local population.
- Conditions
- 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.
| Study group | Role | What they receive |
|---|---|---|
| ADT Group | Participants received continue ADT treatment for at least more than 6 months | |
| RRP Group | Participants have radical prostatectomy performed more than 6 months ago. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the composition of gut microbiome in prostate cancer patients with or without ADT
Total bacterial DNA was extracted from fecal / urine samples by using the bead-beating method with Qiagen QIAamp DNA Microbiome kit. Extracted DNA will be quantified by Nanodrop for PCR reaction.
Measured: Baseline (one-time point only)
Difference in the composition of urinary microbiome in prostate cancer patients with or without ADT
Total bacterial DNA was extracted from fecal / urine samples by using the bead-beating method with Qiagen QIAamp DNA Microbiome kit. Extracted DNA will be quantified by Nanodrop for PCR reaction.
Measured: Baseline (one-time point only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start12 Nov 2018
- Primary completion7 Jun 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 214 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
- NCT03888742
- Sponsor's protocol ID
- CRE 2018.280
- Status last verified
- Dec 2021
- First submitted
- 21 Mar 2019
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fang LC, Merrick GS, Wallner KE. Androgen deprivation therapy: a survival benefit or detriment in men with high-risk prostate cancer? Oncology (Williston Park). 2010 Aug;24(9):790-6, 798.
PubMed 20923031Taylor LG, Canfield SE, Du XL. Review of major adverse effects of androgen-deprivation therapy in men with prostate cancer. Cancer. 2009 Jun 1;115(11):2388-99. doi: 10.1002/cncr.24283.
PubMed 19399748Beauchet O. Testosterone and cognitive function: current clinical evidence of a relationship. Eur J Endocrinol. 2006 Dec;155(6):773-81. doi: 10.1530/eje.1.02306.
PubMed 17132744Lattouf JB, Saad F. Bone complications of androgen deprivation therapy: screening, prevention, and treatment. Curr Opin Urol. 2010 May;20(3):247-52. doi: 10.1097/MOU.0b013e32833835be.
PubMed 20224416Smith MR. Androgen deprivation therapy and risk for diabetes and cardiovascular disease in prostate cancer survivors. Curr Urol Rep. 2008 May;9(3):197-202. doi: 10.1007/s11934-008-0035-y.
PubMed 18765113Saylor PJ, Smith MR. Metabolic complications of androgen deprivation therapy for prostate cancer. J Urol. 2009 May;181(5):1998-2006; discussion 2007-8. doi: 10.1016/j.juro.2009.01.047. Epub 2009 Mar 14.
PubMed 19286225Teoh JY, Chiu PK, Chan SY, Poon DM, Cheung HY, Hou SS, Ng CF. Risk of new-onset diabetes after androgen deprivation therapy for prostate cancer in the Asian population. J Diabetes. 2015 Sep;7(5):672-80. doi: 10.1111/1753-0407.12226. Epub 2014 Dec 22.
PubMed 25266491Vemuri R, Gundamaraju R, Shastri MD, Shukla SD, Kalpurath K, Ball M, Tristram S, Shankar EM, Ahuja K, Eri R. Gut Microbial Changes, Interactions, and Their Implications on Human Lifecycle: An Ageing Perspective. Biomed Res Int. 2018 Feb 26;2018:4178607. doi: 10.1155/2018/4178607. eCollection 2018.
PubMed 29682542David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.
PubMed 24336217De Filippo C, Cavalieri D, Di Paola M, Ramazzotti M, Poullet JB, Massart S, Collini S, Pieraccini G, Lionetti P. Impact of diet in shaping gut microbiota revealed by a comparative study in children from Europe and rural Africa. Proc Natl Acad Sci U S A. 2010 Aug 17;107(33):14691-6. doi: 10.1073/pnas.1005963107. Epub 2010 Aug 2.
PubMed 20679230Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1.
PubMed 21885731Gomes AC, Hoffmann C, Mota JF. The human gut microbiota: Metabolism and perspective in obesity. Gut Microbes. 2018 Jul 4;9(4):308-325. doi: 10.1080/19490976.2018.1465157. Epub 2018 May 24.
PubMed 29667480Ni J, Wu GD, Albenberg L, Tomov VT. Gut microbiota and IBD: causation or correlation? Nat Rev Gastroenterol Hepatol. 2017 Oct;14(10):573-584. doi: 10.1038/nrgastro.2017.88. Epub 2017 Jul 19.
PubMed 28743984Tilg H, Adolph TE, Gerner RR, Moschen AR. The Intestinal Microbiota in Colorectal Cancer. Cancer Cell. 2018 Jun 11;33(6):954-964. doi: 10.1016/j.ccell.2018.03.004. Epub 2018 Apr 12.
PubMed 29657127Mueller S, Saunier K, Hanisch C, Norin E, Alm L, Midtvedt T, Cresci A, Silvi S, Orpianesi C, Verdenelli MC, Clavel T, Koebnick C, Zunft HJ, Dore J, Blaut M. Differences in fecal microbiota in different European study populations in relation to age, gender, and country: a cross-sectional study. Appl Environ Microbiol. 2006 Feb;72(2):1027-33. doi: 10.1128/AEM.72.2.1027-1033.2006.
PubMed 16461645
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross Sectional Study to Assess the Effect of Androgen Deprivation Therapy on Gut and Urinary Microbiota in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT03888742
- Acronym / sponsor ID
- CRE 2018.280
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 25 Mar 2019 (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.
The incidence of prostate cancer is increasing in Hong Kong, as well as that of recurrent or metastatic prostate cancer. Androgen deprivation therapy (ADT) is the standard treatment for recurrent or metastatic prostate cancer, with side effects such as obesity, type 2 diabetes mellitus, metabolic syndrome, osteoporosis and cognitive impairment. With the improvement of treatment, the 5-year survival rate of recurrent and metastatic prostate cancer is up to 20%, and therefore increases the chances of developing such side effects.
Due to the introduction of next generation sequencing, investigators have more knowledge of the microbiota in our body, particularly the gut microbiota. Different studies have related gut dysbiosis with obesity, type 2 diabetes mellitus and metabolic syndrome. If investigators can show that ADT is leading to gut dysbiosis, this could be a way in preventing or treating the side effects of ADT.
This study aims to identify whether ADT in patients with prostate cancer will have different composition in their gut and urine microbiota.
Detailed description
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. (Hong Kong Cancer registry 2015) Its incidence is rising rapidly, almost tripled in the past 10 years. As the elderly population continues to increase, the impact of PCa on the men's health and also the burden on health care system will continue to rise.
Despite the improvement in awareness of the disease and also increasing use of serum prostate specific antigen, many patients still presented at a late stage that beyond cure by local therapy. Together with those patients suffered recurrent disease after local therapy,1 many PCa patients required the use of androgen deprivation therapy (ADT) for the control of disease.
However, unlike other malignancy, PCa is characterized by its slow progression nature and even for metastatic disease the 5-year survival is upto 20%. Therefore, while ADT can provide effective control of disease, there are increasing evidences suggesting that it can also result in many adverse effects in the patients, and these effects are particular important due to the long survival of these patients. From the western literature, the adverse effects can be quite diverse.2 Classical side effects after ADT include mood changes, hot flushes, change in cognitive function,3 loss of libido, erectile dysfunction, osteoporosis and pathological fracture.4 Also there are more and more evidences showed ADT will also altered the metabolic and cardiovascular status of the patients and resulted in increase in insulin resistance and increase in risk of cardiovascular related mortality.5-7 Similarly, from our local data, investigators also observed similar increase in adverse events also happened in Chinese patients treated with ADT.8
There are many possible mechanisms proposed for the occurrence of these adverse events in patients receiving ADT, including increase in obesity, dyslipidaemia, insulin resistance etc. All these factors will lead to increase in metabolic and cardiovascular risk. However, the exact link between of hypogonadism and the development of obesity, dyslipidaemia and insulin resistance was still unclear.
Since the development of the next-generation sequencing, the knowledge of the microbiota in different sites made much progress. Of all other sites, the gut was the most frequently studied. It was found that a number of different conditions were associated with the composition of the gut microbiota, like age9, environmental factors (e.g. diet10-12), medications and diseases like obesity13, inflammatory bowel disease14 and colorectal cancer.15 Other than those mentioned, gender difference in gut microbiota was found in animal studies16 as well as human studies.17-20
On the other hand, urinary microbiota was also found to have gender differences21. The mechanism of this difference is proposed by animal studies to be related to sex hormone16,22, and it was proposed to be due to the hormone-microbe interaction, or due to the sex-specific immune response.23
Recent studies has suggested castration will affect the guts microflora and resulted in the development of obesity in mice.22 However, whether similar effect in human was unknown. Moreover, if the microflora in men was also changed by ADT, this might be one of the underlying mechanism for the increase in cardiovascular and metabolic risk observed in men receiving ADT. Therefore, investigators would like to perform a prospective study to examine the relationship between ADT and gut and urinary microbiota, and also the possible relationship with the development of metabolic and cardiovascular complications in our local population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADT Group | – | –Participants received continue ADT treatment for at least more than 6 months |
| RRP Group | – | –Participants have radical prostatectomy performed more than 6 months ago. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 Patients (150 patients with ADT usage and 150 patients with radical prostatectomy done) who fulfilled the above inclusion criteria with no exclusion criteria will be recruited for the study.
Key inclusion criteria (3 listed)
- Adult patients with age greater than or equal to 18 years old, who are able to provide consent
- Patients who was diagnosed to have prostate cancer
- Patients either received continue ADT treatment for at least more than 6 months or have radical prostatectomy performed more than 6 months ago.
Key exclusion criteria (2 listed)
- Recent use of antibiotics within one month
- History of urinary tract infection in preceding year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in the composition of gut microbiome in prostate cancer patients with or without ADT
Time frame: Baseline (one-time point only)
Total bacterial DNA was extracted from fecal / urine samples by using the bead-beating method with Qiagen QIAamp DNA Microbiome kit. Extracted DNA will be quantified by Nanodrop for PCR reaction.
Difference in the composition of urinary microbiome in prostate cancer patients with or without ADT
Time frame: Baseline (one-time point only)
Total bacterial DNA was extracted from fecal / urine samples by using the bead-beating method with Qiagen QIAamp DNA Microbiome kit. Extracted DNA will be quantified by Nanodrop for PCR reaction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2021.
- Background: PubMed 20923031Fang LC, Merrick GS, Wallner KE. Androgen deprivation therapy: a survival benefit or detriment in men with high-risk prostate cancer? Oncology (Williston Park). 2010 Aug;24(9):790-6, 798.
- Background: PubMed 19399748Taylor LG, Canfield SE, Du XL. Review of major adverse effects of androgen-deprivation therapy in men with prostate cancer. Cancer. 2009 Jun 1;115(11):2388-99. doi: 10.1002/cncr.24283.
- Background: PubMed 17132744Beauchet O. Testosterone and cognitive function: current clinical evidence of a relationship. Eur J Endocrinol. 2006 Dec;155(6):773-81. doi: 10.1530/eje.1.02306.
- Background: PubMed 20224416Lattouf JB, Saad F. Bone complications of androgen deprivation therapy: screening, prevention, and treatment. Curr Opin Urol. 2010 May;20(3):247-52. doi: 10.1097/MOU.0b013e32833835be.
- Background: PubMed 18765113Smith MR. Androgen deprivation therapy and risk for diabetes and cardiovascular disease in prostate cancer survivors. Curr Urol Rep. 2008 May;9(3):197-202. doi: 10.1007/s11934-008-0035-y.
- Background: PubMed 19286225Saylor PJ, Smith MR. Metabolic complications of androgen deprivation therapy for prostate cancer. J Urol. 2009 May;181(5):1998-2006; discussion 2007-8. doi: 10.1016/j.juro.2009.01.047. Epub 2009 Mar 14.
- Background: PubMed 25266491Teoh JY, Chiu PK, Chan SY, Poon DM, Cheung HY, Hou SS, Ng CF. Risk of new-onset diabetes after androgen deprivation therapy for prostate cancer in the Asian population. J Diabetes. 2015 Sep;7(5):672-80. doi: 10.1111/1753-0407.12226. Epub 2014 Dec 22.
- Background: PubMed 29682542Vemuri R, Gundamaraju R, Shastri MD, Shukla SD, Kalpurath K, Ball M, Tristram S, Shankar EM, Ahuja K, Eri R. Gut Microbial Changes, Interactions, and Their Implications on Human Lifecycle: An Ageing Perspective. Biomed Res Int. 2018 Feb 26;2018:4178607. doi: 10.1155/2018/4178607. eCollection 2018.
- Background: PubMed 24336217David LA, Maurice CF, Carmody RN, Gootenberg DB, Button JE, Wolfe BE, Ling AV, Devlin AS, Varma Y, Fischbach MA, Biddinger SB, Dutton RJ, Turnbaugh PJ. Diet rapidly and reproducibly alters the human gut microbiome. Nature. 2014 Jan 23;505(7484):559-63. doi: 10.1038/nature12820. Epub 2013 Dec 11.
- Background: PubMed 20679230De Filippo C, Cavalieri D, Di Paola M, Ramazzotti M, Poullet JB, Massart S, Collini S, Pieraccini G, Lionetti P. Impact of diet in shaping gut microbiota revealed by a comparative study in children from Europe and rural Africa. Proc Natl Acad Sci U S A. 2010 Aug 17;107(33):14691-6. doi: 10.1073/pnas.1005963107. Epub 2010 Aug 2.
- Background: PubMed 21885731Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1.
- Background: PubMed 29667480Gomes AC, Hoffmann C, Mota JF. The human gut microbiota: Metabolism and perspective in obesity. Gut Microbes. 2018 Jul 4;9(4):308-325. doi: 10.1080/19490976.2018.1465157. Epub 2018 May 24.
- Individual participant dataSharing planned: Undecided
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 16 Dec 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difference in the composition of gut microbiome in prostate cancer patients with or without ADT (time frame: Baseline (one-time point only)). The study lists 2 primary outcomes in all. 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 NCT03888742, which also lists 22 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 16 Dec 2021.