Clinical trial · Observational

Effect of ADT in Chinese Male With Prostate Cancer

Prospective Study of the Effect of Androgen Deprivation Therapy (ADT) in Male Patients Suffered Prostate Cancer in Chinese Population

NCT04341324CI-TRIAL-00044604completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
It is an observational study.	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

label
Active arm: Subjects received hormonal therapy
description
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
interventionNames
1. Other: It is an observational study.
label
Control arm: Subjects do not plan to receive hormonal therapy
description
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

Primary outcomes (1)

measure
Change from Baseline cardiovascular risk at 24 months
timeFrame
At baseline and month-24

Eligibility

Eligibility (as posted)

Sex: Male
Minimum age: 18 Years
Maximum age: 100 Years

Show eligibility criteria text

For those received hormonal therapy will be recruited for study (active arm) 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 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

For those do not plan to receive hormonal therapy (based on the clinical assessment by the investigators) will be recruited as control arm

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

Exclusion Criteria:

1. Patient did not able to provide consent or comply with the follow-up arrangement
2. Patient with life expectancy of less than 2 years - based on clinical judgement

References

Publications (8)

BACKGROUNDBeauchet 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. PMID 17132744
BACKGROUNDFang 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. PMID 20923031
BACKGROUNDLattouf 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. PMID 20224416
BACKGROUNDLevine 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. PMID 20124128
BACKGROUNDRampp 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. PMID 18853115
BACKGROUNDSaylor 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. PMID 19286225
BACKGROUNDSmith 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.