Prostate CancerNCT04341324
Effect of ADT in Chinese Male With Prostate Cancer
An observational study of Prostate Cancer, run by Chinese University of Hong Kong.
Trial summary
Many prostate cancer patients required the use of androgen deprivation therapy (ADT) for the control of disease. In this study, the investigators aim at assessing the different in various parameters between PCa patients received ADT and those without ADT. 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?
- It is an observational study.
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 14 Jul 2011to 4 Dec 2019
- 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: 60 patients diagnosed with PCa will be recruited for the study
Who may be able to join
None listed.
Who cannot join
- Patient did not able to provide consent or comply with the follow-up arrangement
- Patient with life expectancy of less than 2 years - based on clinical judgement
About this study
Official title: Prospective Study of the Effect of Androgen Deprivation Therapy (ADT) in Male Patients Suffered Prostate Cancer in Chinese Population
Many prostate cancer patients required the use of androgen deprivation therapy (ADT) for the control of disease.
In this study, the investigators aim at assessing the different in various parameters between PCa patients received ADT and those without ADT.
Read more
60 patients diagnosed with PCa and planned for hormonal therapy will be recruited for study (active arm) and 30 PCa patients that do not planned to receive hormonal therapy (based on the clinical assessment by the investigators) will be recruited as control arm.
After written consent obtained from study subject, a series of investigation will be arranged to assess the following aspect of the subjects before the commenced of ADT:
- General condition - symptoms, general health,
- Body composition - BMI and body composition
- Mental state assessment by Mini-Mental State Examination (MMSE)
- Blood for fasting lipid, sugar, hsCRP and other hormones (about 15cc)
- Cardiovascular status - BP, Ankle-brachial index (ABI), Arterial stiffness, ECG,
- Bone status - bone mineral density by dual-energy X-ray absorptiometry (DEXA) scan
The assessment of general condition, body composition, blood parameter and cardiovascular status will be performed every 26weeks +/- 1 weeks for two years. Bone density measurement will be performed every 52 weeks +/- 2 weeks.
Appropriate medical referral will be made if subject was found to have abnormal metabolic or cardiovascular parameters.
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 4th in annual incidence of male cancer and ranked 8th for cancer-related death in men in Hong Kong which accounts for about 6.2 deaths per 100,000 persons. 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, 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. Classical side effects after ADT include mood changes, hot flushes, change in cognitive function, loss of libido, erectile dysfunction, osteoporosis and pathological fracture. 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.
Traditionally, in order to achieve a complete control of PCa, ADT is given in a continue manner, either in the form of bilateral orchidectomy or regular luteinizing hormone releasing hormone injection. However, in order to balance the benefit and potential of long-term complication, intermittent hormonal therapy (IHT) become increasing common to be used in patients suffered PCa, in particular those with low tumour volume and low-grade disease. However, formal comparison of the benefit, in term of side effect reduction, for IHT compare to traditional continue-hormonal suppression is still lacking.
Unfortunately information regarding the side effects of ADT in Chinese population is lacking. However, there are some evidences from female menopause related studies that there may be some differences in the presentation and prevalence of sex hormone deprivation in difference racial groups. Therefore, there is a need to have more information on the adverse effect profiles related to ADT (both complete and IHT) in Chinese population.
- Conditions
- Prostate Cancer
- Being tested
- It is an observational study.
- Keywords
- Androgen deprivation therapy, 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.
It is an observational study.Other
| Study group | Role | What they receive |
|---|---|---|
| Active arm: Subjects received hormonal therapy | Study subject inclusion criteria
1. Male patients 18 years or older
2. Adenocarcinoma of the prostate either histologically or cytologically confirmed
3. Decided to be put on ADT -bilateral orchidectomy or luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist, with or without additional antiandrogen
4. After ADT performed, serum testosterone level should reach castrated level, i.e. < 50 ng/dL after 6 weeks of treatment
5. Able to consent for the participate in the study Receives: Other: It is an observational study. | |
| Control arm: Subjects do not plan to receive hormonal therapy | Control subject: 1. Male patients 18 years or older 2. Adenocarcinoma of the prostate either histologically or cytologically confirmed 3. Able to consent for the participate in the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline cardiovascular risk at 24 months
Measured by Framingham risk score (Estimation of 10-year Cardiovascular Disease Risk in percentage)
Measured: At baseline and month-24
Secondary outcomes (12)
Change from Baseline total cholesterol at 24 months
Measured by total cholesterol blood test
Measured: At baseline and month-24
Change from Baseline low density lipoprotein at 24 months
Measured by low density lipoprotein blood test
Measured: At baseline and month-24
Change from Baseline high-density lipoprotein at 24 months
Measured by high-density lipoprotein blood test
Measured: At baseline and month-24
Change from Baseline triglyceride at 24 months
Measured by triglyceride blood test
Measured: At baseline and month-24
Change from Baseline body mass index (BMI) at 24 months
Weight and height will be combined to report BMI in kg/m^2
Measured: At baseline and month-24
Change from Baseline body composition at 24 months
Measured by percentage of body fat
Measured: At baseline and month-24
Change from Baseline mental state at 24 months
Measured by the General Practitioner assessment of Cognition (GPCOG). Range of total score: 0-9, higher score mean less cognitive impairment (ie. better outcome).
Measured: At baseline and month-24
Change from Baseline vascular arterial stiffness at 24 months
Vascular arterial stiffness measured by Pulse Wave Velocity (m/s) using non-invasive vascular screening device
Measured: At baseline and month-24
Change from Baseline ankle brachial index (ABI) at 24 months
ABI (ratio of the blood pressure at the ankle to the blood pressure in the upper arm) measured by using non-invasive vascular screening device
Measured: At baseline and month-24
Compare cardiovascular events
Measured by the cardiovascular adverse event rate
Measured: At month-24
Change from Baseline bone mineral density at 24 months
Bone mineral density measured by using bone density scanning device
Measured: At baseline and month-24
Compare skeletal related events
Measured by the fracture rate
Measured: At month-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start14 Jul 2011
- Primary completion4 Dec 2019
- Study completion4 Dec 2019
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 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
- NCT04341324
- Sponsor's protocol ID
- CRE 2010.577-T
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2020
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beauchet 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 17132744Fang 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 20923031Lattouf 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 20224416Levine GN, D'Amico AV, Berger P, Clark PE, Eckel RH, Keating NL, Milani RV, Sagalowsky AI, Smith MR, Zakai N; American Heart Association Council on Clinical Cardiology and Council on Epidemiology and Prevention, the American Cancer Society, and the American Urological Association. Androgen-deprivation therapy in prostate cancer and cardiovascular risk: a science advisory from the American Heart Association, American Cancer Society, and American Urological Association: endorsed by the American Society for Radiation Oncology. Circulation. 2010 Feb 16;121(6):833-40. doi: 10.1161/CIRCULATIONAHA.109.192695. Epub 2010 Feb 1. No abstract available.
PubMed 20124128Rampp T, Tan L, Zhang L, Sun ZJ, Klose P, Musial F, Dobos GJ. Menopause in German and Chinese women--an analysis of symptoms, TCM-diagnosis and hormone status. Chin J Integr Med. 2008 Sep;14(3):194-6. doi: 10.1007/s11655-008-0194-1. Epub 2008 Oct 14.
PubMed 18853115Saylor 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 19286225Smith MR. Treatment-related diabetes and cardiovascular disease in prostate cancer survivors. Ann Oncol. 2008 Sep;19 Suppl 7(Suppl 7):vii86-90. doi: 10.1093/annonc/mdn458. No abstract available.
PubMed 18790986Taylor 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 19399748
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Effect of Androgen Deprivation Therapy (ADT) in Male Patients Suffered Prostate Cancer in Chinese Population
- ClinicalTrials.gov ID
- NCT04341324
- Acronym / sponsor ID
- CRE 2010.577-T
- Conditions
- Prostate Cancer
- Keywords
- Androgen deprivation therapy, Prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 14 Jul 2011 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 10 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.
Many prostate cancer patients required the use of androgen deprivation therapy (ADT) for the control of disease.
In this study, the investigators aim at assessing the different in various parameters between PCa patients received ADT and those without ADT.
60 patients diagnosed with PCa and planned for hormonal therapy will be recruited for study (active arm) and 30 PCa patients that do not planned to receive hormonal therapy (based on the clinical assessment by the investigators) will be recruited as control arm.
After written consent obtained from study subject, a series of investigation will be arranged to assess the following aspect of the subjects before the commenced of ADT:
- General condition - symptoms, general health,
- Body composition - BMI and body composition
- Mental state assessment by Mini-Mental State Examination (MMSE)
- Blood for fasting lipid, sugar, hsCRP and other hormones (about 15cc)
- Cardiovascular status - BP, Ankle-brachial index (ABI), Arterial stiffness, ECG,
- Bone status - bone mineral density by dual-energy X-ray absorptiometry (DEXA) scan
The assessment of general condition, body composition, blood parameter and cardiovascular status will be performed every 26weeks +/- 1 weeks for two years. Bone density measurement will be performed every 52 weeks +/- 2 weeks.
Appropriate medical referral will be made if subject was found to have abnormal metabolic or cardiovascular parameters.
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 4th in annual incidence of male cancer and ranked 8th for cancer-related death in men in Hong Kong which accounts for about 6.2 deaths per 100,000 persons. 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, 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. Classical side effects after ADT include mood changes, hot flushes, change in cognitive function, loss of libido, erectile dysfunction, osteoporosis and pathological fracture. 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.
Traditionally, in order to achieve a complete control of PCa, ADT is given in a continue manner, either in the form of bilateral orchidectomy or regular luteinizing hormone releasing hormone injection. However, in order to balance the benefit and potential of long-term complication, intermittent hormonal therapy (IHT) become increasing common to be used in patients suffered PCa, in particular those with low tumour volume and low-grade disease. However, formal comparison of the benefit, in term of side effect reduction, for IHT compare to traditional continue-hormonal suppression is still lacking.
Unfortunately information regarding the side effects of ADT in Chinese population is lacking. However, there are some evidences from female menopause related studies that there may be some differences in the presentation and prevalence of sex hormone deprivation in difference racial groups. Therefore, there is a need to have more information on the adverse effect profiles related to ADT (both complete and IHT) in Chinese population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active arm: Subjects received hormonal therapy | – | Other: It is an observational study.Study subject inclusion criteria 1. Male patients 18 years or older 2. Adenocarcinoma of the prostate either histologically or cytologically confirmed 3. Decided to be put on ADT -bilateral orchidectomy or luteinizing hormone-releasing hormone (LHRH) agonist or LHRH antagonist, with or without additional antiandrogen 4. After ADT performed, serum testosterone level should reach castrated level, i.e. < 50 ng/dL after 6 weeks of treatment 5. Able to consent for the participate in the study |
| Control arm: Subjects do not plan to receive hormonal therapy | – | –Control subject: 1. Male patients 18 years or older 2. Adenocarcinoma of the prostate either histologically or cytologically confirmed 3. Able to consent for the participate in the study |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 60 patients diagnosed with PCa will be recruited for the study
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Patient did not able to provide consent or comply with the follow-up arrangement
- Patient with life expectancy of less than 2 years - based on clinical judgement
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 |
|---|---|---|
| It is an observational study. | Other | Active arm: Subjects received hormonal therapy |
Primary outcome
Change from Baseline cardiovascular risk at 24 months
Time frame: At baseline and month-24
Measured by Framingham risk score (Estimation of 10-year Cardiovascular Disease Risk in percentage)
12 secondary outcomes
Change from Baseline total cholesterol at 24 months
Time frame: At baseline and month-24
Change from Baseline low density lipoprotein at 24 months
Time frame: At baseline and month-24
Change from Baseline high-density lipoprotein at 24 months
Time frame: At baseline and month-24
Change from Baseline triglyceride at 24 months
Time frame: At baseline and month-24
Change from Baseline body mass index (BMI) at 24 months
Time frame: At baseline and month-24
Change from Baseline body composition at 24 months
Time frame: At baseline and month-24
Change from Baseline mental state at 24 months
Time frame: At baseline and month-24
Change from Baseline vascular arterial stiffness at 24 months
Time frame: At baseline and month-24
Change from Baseline ankle brachial index (ABI) at 24 months
Time frame: At baseline and month-24
Compare cardiovascular events
Time frame: At month-24
Change from Baseline bone mineral density at 24 months
Time frame: At baseline and month-24
Compare skeletal related events
Time frame: At month-24
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 10 Apr 2020.
- 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 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 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 20124128Levine GN, D'Amico AV, Berger P, Clark PE, Eckel RH, Keating NL, Milani RV, Sagalowsky AI, Smith MR, Zakai N; American Heart Association Council on Clinical Cardiology and Council on Epidemiology and Prevention, the American Cancer Society, and the American Urological Association. Androgen-deprivation therapy in prostate cancer and cardiovascular risk: a science advisory from the American Heart Association, American Cancer Society, and American Urological Association: endorsed by the American Society for Radiation Oncology. Circulation. 2010 Feb 16;121(6):833-40. doi: 10.1161/CIRCULATIONAHA.109.192695. Epub 2010 Feb 1. No abstract available.
- Background: PubMed 18853115Rampp T, Tan L, Zhang L, Sun ZJ, Klose P, Musial F, Dobos GJ. Menopause in German and Chinese women--an analysis of symptoms, TCM-diagnosis and hormone status. Chin J Integr Med. 2008 Sep;14(3):194-6. doi: 10.1007/s11655-008-0194-1. Epub 2008 Oct 14.
- 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 18790986Smith MR. Treatment-related diabetes and cardiovascular disease in prostate cancer survivors. Ann Oncol. 2008 Sep;19 Suppl 7(Suppl 7):vii86-90. doi: 10.1093/annonc/mdn458. No abstract available.
- 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.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Chinese University of 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 0 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 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Change from Baseline cardiovascular risk at 24 months (time frame: At baseline and month-24). 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 NCT04341324, 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 10 Apr 2020.