Prostate CancerNCT07057375
The Effect of Pulsed Electromagnetic Field Therapy on Muscle Mass and Muscle Strength in Prostate Cancer Patients Treated With Androgen Deprivation Therapy
A study testing Pulsed electromagnetic fields Thearpy in people with Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This study is to assess the effect of Pulsed electromagnetic fields (PEMF) on improving muscle mass and strength in prostate cancer patients with ADT. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Pulsed electromagnetic fields Thearpy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adult patients with age greater than or equal to 18 years old.
- Histologically documented PCa
- No evidence of distant metastasis (M1 disease)
- With ADT exposure from six months to three years
- Expected to continue for at least six months
- At least four weeks after radical prostatectomy or completed radiotherapy
Who cannot join
- Patients are still under active treatment, such as radiotherapy
- Patients who are unable to walk for 400 m or undertake exercise that will affect the clinical assessment of muscle strength
- Patients with amputated lower limbs or other body deformities that will affect the treatment protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin
Chi Fai NG, MD, 3505 2625, ngcf@surgery.cuhk.edu.hk
About this study
Official title: A Prospective Randomized Study to Investigate the Effect of Pulsed Electromagnetic Field Therapy on Muscle Mass and Muscle Strength in Prostate Cancer Patients Treated With Androgen Deprivation Therapy
This study is to assess the effect of Pulsed electromagnetic fields (PEMF) on improving muscle mass and strength in prostate cancer patients with ADT.
Read the detailed description
This randomised parallel-group study assesses the efficacy, safety and tolerability of Pulsed electromagnetic fields (PEMF) on the muscle mass and strength in PCa patients treated with ADT.Treatment will be delivered using the BIXEPS system (QuantumTX, Singapore). During each treatment, the subject's quadriceps (thigh) region will be put into the machine and treated for 10 minutes for each lower limbs. The whole treatment consists of 1 therapy session per week for 12 weeks. The two lower limbs will be treated alternatively during the treatment. A set of assessments, including body composition assessment, muscle function assessment, questionnaire assessment, and blood and urine for inflammation and cytokines measurement, will be performed at baseline before the start of the first treatment, week 5 and week 12.
- Conditions
- Prostate Cancer
- Being tested
- Pulsed electromagnetic fields Thearpy, Sham Therapy
- Keywords
- ADT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed electromagnetic fields ThearpyDevice
Pulsed electromagnetic fields (PEMF) is a non-invasive and non-thermal treatment used to stimulate muscle regeneration, resulting in increased muscle mass and strength.
Sham TherapyDevice
Sham Therapy
| Study group | Role | What they receive |
|---|---|---|
| Active Therapy | Active comparator | Pulsed electromagnetic fields therapy will be delivered using the BIXEPS system (QuantumTX, Singapore). Receives: Device: Pulsed electromagnetic fields Thearpy |
| Sham Therapy | Sham comparator | Sham thearpy will be delivered using the BIXEPS system (QuantumTX, Singapore). Receives: Device: Sham Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Up and Go tests (TUG test)
Changes in time for Time Up and Go tests (TUG test) at the end of the 12-week treatment
Measured: Baseline, Week 5, Week 12
Secondary outcomes (9)
Appendicular skeletal muscle mass
Changes in appendicular skeletal muscle mass at the end of the 12-week treatment
Measured: Baseline, Week 5, Week 12
Body Mass Index (BMI)
Changes in BMI at the end of the 12-week treatment
Measured: Baseline, Week 5, Week 12
Calf circumference
Changes in calf circumference at the end of the 12-week treatment
Measured: Baseline, Week 5, Week 12
Hand grip Strength
Changes in hand grip strength at the end of the 12-week treatment
Measured: Baseline, Week 5, Week 12
Five times sit-to-stand tests
Changes in time for Five times sit-to-stand tests at the end of the 12-week treatment
Measured: Baseline, Week 5, Week 12
Quality of life measured by 5-level EQ-5D version (ED-5Q-5L)questionnaire
Quality of life measured by ED-5Q-5L questionnaire, which include the the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS range from 0 to 100).the higher the score the better in quality of life
Measured: Baseline, Week 5, Week 12
Sarcopenia measured by SARC-F(strength, walking, rising from a chair, climbing stairs, and experiencing falls) score
Changes in SARC-F scores at the end of the 12-week treatment. The score equal to or greater than 4 is predictive of sarcopenia
Measured: Baseline, Week 5, Week 12
Concentration of Cytokines and inflammatory markers
Changes in a panel of cytokines and inflammatory markers at the end of 12 week treatment
Measured: Baseline, Week 5, Week 12
Quality of life measured by FACT-P Questionnaire
The higher the score, the better of Quality of life
Measured: Baseline, Week 5, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NG Chi Fai, Chinese University of Hong Kong
- Investigators
- Chi Fai NG, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057375
- Sponsor's protocol ID
- CRE-2024.600-T
- Status last verified
- Oct 2026
- First submitted
- 4 May 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith MR, Saad F, Egerdie B, Sieber PR, Tammela TL, Ke C, Leder BZ, Goessl C. Sarcopenia during androgen-deprivation therapy for prostate cancer. J Clin Oncol. 2012 Sep 10;30(26):3271-6. doi: 10.1200/JCO.2011.38.8850. Epub 2012 May 29.
PubMed 22649143Basaria S, Lieb J 2nd, Tang AM, DeWeese T, Carducci M, Eisenberger M, Dobs AS. Long-term effects of androgen deprivation therapy in prostate cancer patients. Clin Endocrinol (Oxf). 2002 Jun;56(6):779-86. doi: 10.1046/j.1365-2265.2002.01551.x.
PubMed 12072048Beaudart C, McCloskey E, Bruyere O, Cesari M, Rolland Y, Rizzoli R, Araujo de Carvalho I, Amuthavalli Thiyagarajan J, Bautmans I, Bertiere MC, Brandi ML, Al-Daghri NM, Burlet N, Cavalier E, Cerreta F, Cherubini A, Fielding R, Gielen E, Landi F, Petermans J, Reginster JY, Visser M, Kanis J, Cooper C. Sarcopenia in daily practice: assessment and management. BMC Geriatr. 2016 Oct 5;16(1):170. doi: 10.1186/s12877-016-0349-4.
PubMed 27716195Saylor PJ, Smith MR. Metabolic complications of androgen deprivation therapy for prostate cancer. J Urol. 2013 Jan;189(1 Suppl):S34-42; discussion S43-4. doi: 10.1016/j.juro.2012.11.017.
PubMed 23234628Greenspan SL, Coates P, Sereika SM, Nelson JB, Trump DL, Resnick NM. Bone loss after initiation of androgen deprivation therapy in patients with prostate cancer. J Clin Endocrinol Metab. 2005 Dec;90(12):6410-7. doi: 10.1210/jc.2005-0183. Epub 2005 Sep 27.
PubMed 16189261Storer TW, Magliano L, Woodhouse L, Lee ML, Dzekov C, Dzekov J, Casaburi R, Bhasin S. Testosterone dose-dependently increases maximal voluntary strength and leg power, but does not affect fatigability or specific tension. J Clin Endocrinol Metab. 2003 Apr;88(4):1478-85. doi: 10.1210/jc.2002-021231.
PubMed 12679426Galvao DA, Nosaka K, Taaffe DR, Spry N, Kristjanson LJ, McGuigan MR, Suzuki K, Yamaya K, Newton RU. Resistance training and reduction of treatment side effects in prostate cancer patients. Med Sci Sports Exerc. 2006 Dec;38(12):2045-52. doi: 10.1249/01.mss.0000233803.48691.8b.
PubMed 17146309Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
PubMed 8445433Hanson ED, Srivatsan SR, Agrawal S, Menon KS, Delmonico MJ, Wang MQ, Hurley BF. Effects of strength training on physical function: influence of power, strength, and body composition. J Strength Cond Res. 2009 Dec;23(9):2627-37. doi: 10.1519/JSC.0b013e3181b2297b.
PubMed 19910811Denison HJ, Cooper C, Sayer AA, Robinson SM. Prevention and optimal management of sarcopenia: a review of combined exercise and nutrition interventions to improve muscle outcomes in older people. Clin Interv Aging. 2015 May 11;10:859-69. doi: 10.2147/CIA.S55842. eCollection 2015.
PubMed 25999704Esper P, Mo F, Chodak G, Sinner M, Cella D, Pienta KJ. Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument. Urology. 1997 Dec;50(6):920-8. doi: 10.1016/S0090-4295(97)00459-7.
PubMed 9426724Wong CK, Choi EP, Tsu JH, Ho BS, Ng AT, Chin WY, Yiu MK. Psychometric properties of Functional Assessment of Cancer Therapy-Prostate (FACT-P) in Chinese patients with prostate cancer. Qual Life Res. 2015 Oct;24(10):2397-402. doi: 10.1007/s11136-015-0993-8. Epub 2015 Apr 16.
PubMed 25877953
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study to Investigate the Effect of Pulsed Electromagnetic Field Therapy on Muscle Mass and Muscle Strength in Prostate Cancer Patients Treated With Androgen Deprivation Therapy
- ClinicalTrials.gov ID
- NCT07057375
- Acronym / sponsor ID
- CRE-2024.600-T
- Conditions
- Prostate Cancer
- Keywords
- ADT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 Jul 2025 (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.
This study is to assess the effect of Pulsed electromagnetic fields (PEMF) on improving muscle mass and strength in prostate cancer patients with ADT.
Detailed description
This randomised parallel-group study assesses the efficacy, safety and tolerability of Pulsed electromagnetic fields (PEMF) on the muscle mass and strength in PCa patients treated with ADT.Treatment will be delivered using the BIXEPS system (QuantumTX, Singapore). During each treatment, the subject's quadriceps (thigh) region will be put into the machine and treated for 10 minutes for each lower limbs. The whole treatment consists of 1 therapy session per week for 12 weeks. The two lower limbs will be treated alternatively during the treatment. A set of assessments, including body composition assessment, muscle function assessment, questionnaire assessment, and blood and urine for inflammation and cytokines measurement, will be performed at baseline before the start of the first treatment, week 5 and week 12.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Therapy | Active comparator | Device: Pulsed electromagnetic fields ThearpyPulsed electromagnetic fields therapy will be delivered using the BIXEPS system (QuantumTX, Singapore). |
| Sham Therapy | Sham comparator | Device: Sham TherapySham thearpy will be delivered using the BIXEPS system (QuantumTX, Singapore). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients with age greater than or equal to 18 years old.
- Histologically documented PCa
- No evidence of distant metastasis (M1 disease)
- With ADT exposure from six months to three years
- Expected to continue for at least six months
Key exclusion criteria (3 listed)
- Patients are still under active treatment, such as radiotherapy
- Patients who are unable to walk for 400 m or undertake exercise that will affect the clinical assessment of muscle strength
- Patients with amputated lower limbs or other body deformities that will affect the treatment protocol
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 |
|---|---|---|
| Pulsed electromagnetic fields ThearpyPulsed electromagnetic fields (PEMF) is a non-invasive and non-thermal treatment used to stimulate muscle regeneration, resulting in increased muscle mass and strength. | Device | Active Therapy |
| Sham TherapySham Therapy | Device | Sham Therapy |
Primary outcome
Time Up and Go tests (TUG test)
Time frame: Baseline, Week 5, Week 12
Changes in time for Time Up and Go tests (TUG test) at the end of the 12-week treatment
9 secondary outcomes
Appendicular skeletal muscle mass
Time frame: Baseline, Week 5, Week 12
Body Mass Index (BMI)
Time frame: Baseline, Week 5, Week 12
Calf circumference
Time frame: Baseline, Week 5, Week 12
Hand grip Strength
Time frame: Baseline, Week 5, Week 12
Five times sit-to-stand tests
Time frame: Baseline, Week 5, Week 12
Quality of life measured by 5-level EQ-5D version (ED-5Q-5L)questionnaire
Time frame: Baseline, Week 5, Week 12
Sarcopenia measured by SARC-F(strength, walking, rising from a chair, climbing stairs, and experiencing falls) score
Time frame: Baseline, Week 5, Week 12
Concentration of Cytokines and inflammatory markers
Time frame: Baseline, Week 5, Week 12
Quality of life measured by FACT-P Questionnaire
Time frame: Baseline, Week 5, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 22649143Smith MR, Saad F, Egerdie B, Sieber PR, Tammela TL, Ke C, Leder BZ, Goessl C. Sarcopenia during androgen-deprivation therapy for prostate cancer. J Clin Oncol. 2012 Sep 10;30(26):3271-6. doi: 10.1200/JCO.2011.38.8850. Epub 2012 May 29.
- Background: PubMed 12072048Basaria S, Lieb J 2nd, Tang AM, DeWeese T, Carducci M, Eisenberger M, Dobs AS. Long-term effects of androgen deprivation therapy in prostate cancer patients. Clin Endocrinol (Oxf). 2002 Jun;56(6):779-86. doi: 10.1046/j.1365-2265.2002.01551.x.
- Background: PubMed 27716195Beaudart C, McCloskey E, Bruyere O, Cesari M, Rolland Y, Rizzoli R, Araujo de Carvalho I, Amuthavalli Thiyagarajan J, Bautmans I, Bertiere MC, Brandi ML, Al-Daghri NM, Burlet N, Cavalier E, Cerreta F, Cherubini A, Fielding R, Gielen E, Landi F, Petermans J, Reginster JY, Visser M, Kanis J, Cooper C. Sarcopenia in daily practice: assessment and management. BMC Geriatr. 2016 Oct 5;16(1):170. doi: 10.1186/s12877-016-0349-4.
- Background: PubMed 23234628Saylor PJ, Smith MR. Metabolic complications of androgen deprivation therapy for prostate cancer. J Urol. 2013 Jan;189(1 Suppl):S34-42; discussion S43-4. doi: 10.1016/j.juro.2012.11.017.
- Background: PubMed 16189261Greenspan SL, Coates P, Sereika SM, Nelson JB, Trump DL, Resnick NM. Bone loss after initiation of androgen deprivation therapy in patients with prostate cancer. J Clin Endocrinol Metab. 2005 Dec;90(12):6410-7. doi: 10.1210/jc.2005-0183. Epub 2005 Sep 27.
- Background: PubMed 12679426Storer TW, Magliano L, Woodhouse L, Lee ML, Dzekov C, Dzekov J, Casaburi R, Bhasin S. Testosterone dose-dependently increases maximal voluntary strength and leg power, but does not affect fatigability or specific tension. J Clin Endocrinol Metab. 2003 Apr;88(4):1478-85. doi: 10.1210/jc.2002-021231.
- Background: PubMed 17146309Galvao DA, Nosaka K, Taaffe DR, Spry N, Kristjanson LJ, McGuigan MR, Suzuki K, Yamaya K, Newton RU. Resistance training and reduction of treatment side effects in prostate cancer patients. Med Sci Sports Exerc. 2006 Dec;38(12):2045-52. doi: 10.1249/01.mss.0000233803.48691.8b.
- Background: PubMed 8445433Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
- Background: PubMed 19910811Hanson ED, Srivatsan SR, Agrawal S, Menon KS, Delmonico MJ, Wang MQ, Hurley BF. Effects of strength training on physical function: influence of power, strength, and body composition. J Strength Cond Res. 2009 Dec;23(9):2627-37. doi: 10.1519/JSC.0b013e3181b2297b.
- Background: PubMed 25999704Denison HJ, Cooper C, Sayer AA, Robinson SM. Prevention and optimal management of sarcopenia: a review of combined exercise and nutrition interventions to improve muscle outcomes in older people. Clin Interv Aging. 2015 May 11;10:859-69. doi: 10.2147/CIA.S55842. eCollection 2015.
- Background: PubMed 9426724Esper P, Mo F, Chodak G, Sinner M, Cella D, Pienta KJ. Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument. Urology. 1997 Dec;50(6):920-8. doi: 10.1016/S0090-4295(97)00459-7.
- Background: PubMed 25877953Wong CK, Choi EP, Tsu JH, Ho BS, Ng AT, Chin WY, Yiu MK. Psychometric properties of Functional Assessment of Cancer Therapy-Prostate (FACT-P) in Chinese patients with prostate cancer. Qual Life Res. 2015 Oct;24(10):2397-402. doi: 10.1007/s11136-015-0993-8. Epub 2015 Apr 16.
- Individual participant dataSharing planned: No
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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.
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?
A study testing Pulsed electromagnetic fields Thearpy in people with 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 6 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi Fai NG, MD (3505 2625, ngcf@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Up and Go tests (TUG test) (time frame: Baseline, Week 5, Week 12). 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 NCT07057375, which also lists 12 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 22 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.