Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
The efficacy of transdermal estradiol in mitigating the deterioration of EPIC-26 (The Expanded Prostate Cancer Index Composite) sexual function domain scores caused by androgen deprivation therapy. |
Compared between the two arms. Scores scaled from 0 - 100, higher score means better sexual function. |
Twelve and six months. |
|
Secondary |
The occurrence of androgen deprivation therapy induced adverse effects. |
Compared between different groups. Assessed by CTCAE (Common Termionology Criteria for Adverse Events). Number of participants with androgen deprivation therapy related adverse events, and grading of adverse event from 1 - 5. Higher grading indicates worse adverse event. |
Twelve and six months. |
|
Secondary |
Number of participants with transdermal estradiol-related adverse events as assessed by CTCAE (Common Terminology Criteria for Adverse Events). |
Transdermal estradiol arm. Number and grading of adverse events from 1 - 5. Higher grading means worse adverse event. |
Twelve and six months. |
|
Secondary |
Impact of transdermal estradiol with or without 6-month supervised resistance training on one repetition maximum tests of both the leg press and barbell biceps curl, and maximal hand grip strength assessed with a dynamometer. |
Compared between different groups. One repetition maximum tests and maximal hand grip strength assessed as kilograms or newtons. Higher kilograms or newtons indicates higher strength. |
Twelve and six months. |
|
Secondary |
Impact of transdermal estradiol with or without 6-month supervised resistance training on explosive strength of the leg extensors assessed with a countermovement jump (CMJ). |
Compared between different groups. From CMJ flight time is defined as milliseconds. Higher flight time in milliseconds represents higher jump height and explosive strength. |
Twelve and six months. |
|
Secondary |
Impact of transdermal estradiol with or without 6-month supervised resistance training on 6-minute walk (functional capacity). |
Compared between different groups. Walking distance and heart rate will be collected from 6-minute walk test. Higher walking distance with lower heart rate indicates better functional capacity. |
Twelve and six months. |
|
Secondary |
Impact of transdermal estradiol with or without 6-month supervised resistance training on loaded 10-stair climb test (functional capacity). |
Compared between different groups. Time taken to ascend and descend from 10-stair climb test. Less time taken to complete 10-stair climb test indicates better functional capacity. |
Twelve and six months. |
|
Secondary |
Impact of transdermal estradiol with or without 6-month supervised resistance training on body composition. |
Compared between different groups. More lean mass, and less fat mass indicates better body composition. |
Twelve and six months. |
|
Secondary |
Impact of transdermal estradiol with or without 6-month supervised resistance training on bone mineral density. |
Compared between different groups. Higher bone mineral density indicates better outcome. |
Twelve and six months. |
|
Secondary |
Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh muscle mass. |
Compared between different groups. Higher mid-thigh muscles cross-sectional area indicates higher mid-thigh muscle mass. |
Twelve and six months. |
|
Secondary |
Impact of transdermal estradiol with or without 6-month supervised resistance training on mid-thigh fat mass. |
Compared between different groups. Lower adipose tissue size indicates less mid-thigh fat mass. |
Twelve and six months. |
|
Secondary |
Impact of transdermal estradiol with or without 6-month supervised resistance training on hormone (testosterone and estradiol) levels, and cancer (PSA) status. |
Compared between different groups. Higher or lower hormones levels could indicate better outcome, depending on the arm of the participant, and overall status. Lower PSA concentration usually indicates better outcome. |
Twelve and six months. |
|
Secondary |
Impact of transdermal estradiol with or without 6-month supervised resistance training on concentration of PVK, IL-6, TNF-a, AFOS, Alat, Krea, Cholesterol, LDL-C, HDL-C, and triglycerides). |
Compared between different groups. Higher or lower concentration of biomarkers can indicate better outcome, depending on the exact biomarker. |
Twelve and six months. |
|
Secondary |
Impact of transdermal estradiol with or without 6-month supervised resistance training on type I and II myofibers' cross-sectional area, myonuclei, myonuclear domain, the satellite cell count, androgen receptor and myostatin content |
Compared between different groups. Higher type I and II myofibers' cross-sectional area indicates improved skeletal muscle characteristics. Higher myonuclei, myonuclear domain, satellitte cell count, and androgen and myostatin content usually indicates improved cellular function. |
Twelve and six months. |
|
Secondary |
Impact of transdermal estradiol with or without 6-month supervised resistance training on muscle cellular function (e.g., HSP70, alpha B-crystallin, HSP60, cytochrome c oxidase subunit IV proteins) |
Compared between different groups. Higher or lower concentration of proteins could indicate improved or worsen muscle cellular function, depending on the exact protein. |
Twelve and six months. |
|
Secondary |
Number of participants with resistance training induced adverse events. |
Compared between different groups. Assessed by CTCAE (Common Termionology Criteria for Adverse Events). Number of participants with androgen deprivation therapy related adverse events, and grading of adverse event from 1 - 5. Higher grading indicates worse adverse event. |
Twelve and six months. |
|
Secondary |
The World Health Organization Quality of Life Brief Version (WHOQOL-BREF). |
Compared between different groups. Subdomain scores scaled from 0 to 100. Higher overall and subdomain score in WHOQOL-BREF indicates higher quality of life. |
Twelve and six months. |
|
Secondary |
The Patient Health Questionnaire score (PHQ-9) overall and subdomain score. |
Compared between different groups. Scores scaled from 0 to 27. Higher overall score in PHQ-9 indicates more depressive symptoms. |
Twelve and six months. |
|