Effect of ADT in Chinese Male With Prostate Cancer

NCT04341324 | Completed

• 1 other identifier: CRE 2010.577-T
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Prostate Cancer

Keywords

Androgen deprivation therapy; Prostate cancer

Outcome Measures

Primary Outcomes (1)

• Change from Baseline cardiovascular risk at 24 months

  Measured by Framingham risk score (Estimation of 10-year Cardiovascular Disease Risk in percentage)

  At baseline and month-24

Secondary Outcomes (12)

• Change from Baseline total cholesterol at 24 months

  At baseline and month-24

• Change from Baseline low density lipoprotein at 24 months

  At baseline and month-24

• Change from Baseline high-density lipoprotein at 24 months

  At baseline and month-24

• Change from Baseline triglyceride at 24 months

  At baseline and month-24

• Change from Baseline body mass index (BMI) at 24 months

  At baseline and month-24

Study Arms (2)

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

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

Interventions

It is an observational study. OTHER

Active arm: Subjects received hormonal therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Only mole can develop prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 patients diagnosed with PCa will be recruited for the study

You may qualify if:

• Male patients 18 years or older
• Adenocarcinoma of the prostate either histologically or cytologically confirmed
• Decided to be put on ADT -bilateral orchidectomy or LHRH agonist or LHRH antagonist, with or without additional antiandrogen
• After ADT performed, serum testosterone level should reach castrated level, i.e. \< 50 ng/dL after 6 weeks of treatment
• 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:
• Male patients 18 years or older
• Adenocarcinoma of the prostate either histologically or cytologically confirmed
• Able to consent for the participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Related Publications (8)

• 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.

  PMID: 17132744 BACKGROUND

• 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.

  PMID: 20923031 BACKGROUND

• Lattouf 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 BACKGROUND

• Levine 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 BACKGROUND

• Rampp 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 BACKGROUND

• Saylor 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 BACKGROUND

• Smith 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.

  PMID: 18790986 BACKGROUND

• Taylor 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.

  PMID: 19399748 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood for fasting lipid, sugar, hsCRP and other hormones (about 15cc) will be assessed in each study visit.

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: COHORT
• 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 10, 2020
• Study Start: July 14, 2011
• Primary Completion: December 4, 2019
• Study Completion: December 4, 2019
• Last Updated: April 10, 2020

Record last verified: 2020-04