Prostate CancerNCT04050397
Exercise and Quality of Life During Androgen Deprivation Therapy
A study testing Progressive supervised weight training and Lecture in people with Prostate Cancer, run by Tampere University Hospital at 1 site in Finland.
Trial summary
This study evaluates effects of supervised exercise in reducing adverse effects of hormonal treatment, increasing quality of life and in inducing a long-term change into more active lifestyle in prostate cancer patients on androgen deprivation therapy. 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?
- Progressive supervised weight training and Lecture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 15 Aug 2019to 15 Aug 2021
- Phase
- Interventional
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing castration treatment for prostate cancer
- Informed consent for the study
Who cannot join
- Unable to participate in exercise (ECOG 2 or greater)
- High bone fracture risk (as judged by the primary physician)
- Unable to understand spoken and written instructions in Finnish
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Tampere University Hospital
Tampere, 33520
Teemu Murtola, MD, PhD, +358 3 311 65015, teemu.murtola@tuni.fi
Teuvo Tammela, MD PhD, +358 3 311 64621, teuvo.tammela@tuni.fi
About this study
Official title: Exercise Intervention to Reduce Adverse Quality of Life Effects From Androgen Deprivation Therapy for Prostate Cancer - Randomized Clinical Trial
This study evaluates effects of supervised exercise in reducing adverse effects of hormonal treatment, increasing quality of life and in inducing a long-term change into more active lifestyle in prostate cancer patients on androgen deprivation therapy. All participants will attend a starting lecture at the beginning of the trial, after which they are randomly allocated to attend 3 months of either supervised or non-supervised exercise program. Leisure time activity, quality of life, blood sugar and cholesterol values, and body composition of participants will be evaluated at three time-points; at recruitment, after 12 weeks and after 24 weeks. Effects on quality of life will also be qualitatively evaluated with single- and group interviews.
Read the detailed description
Androgen deprivation therapy (ADT) is commonly used in management of advanced or recurrent prostate cancer. It also frequently used adjuvant to curative-intent radiation therapy for localized prostate cancer. Low testosterone levels during androgen deprivation commonly cause adverse effects reducing quality of life. Most common adverse effects include fatigue, weight gain, loss of lean muscle mass, hyperglycemia and hypercholesterolemia.
Regular exercise, especially programs involving combination of both aerobic exercise and resistance training has been shown to reduce to reduce adverse effects of ADT on physical functioning and quality of life. It may also improve disease prognosis.
The study compares effects of supervised and unsupervised exercise on plasma lipid parameters (total cholesterol, LDL, HDL and triglycerides) and glucose levels (fasting plasma glucose, glycated hemoglobin), overall quality of life and on average daily exercise activity in men with prostate cancer and under ADT. As secondary outcome we will study effect on continued exercise activity after the intervention, changes in body composition, blood pressure and risk of fractures, castration resistance as well as death due to prostate cancer and due to any cause.
Study hypothesis is that supervised exercise will improve quality of life, lipid and glucose parameters and increase daily exercise activity more that non-supervised exercise. We also expect higher continued exercise activity, greater changes in body composition and blood pressure and lowered risk of fractures and death in the supervised exercise group.
This is a randomized, controlled clinical trial. The study aims to recruit 40 men on ADT for prostate cancer. This will be a pilot study to estimate effect sizes in Finnish population to inform further larger trial.
All participants attend introductory lecture, where a urologist informs them about adverse effects of ADT and positive effects of exercise during ADT, exercise instructor gives advice for training both at home and in the gym and nutritional therapeutist tells about nutrition to overcome adverse effects of ADT and support training.
After the introductory lecture the participants are randomized 1:1 to either the supervised or non-supervised exercise group (Figure). Men in the supervised group participate in progressive group exercise sessions twice a week for total of 12 weeks at the Varala sports academy in Tampere, Finland. Each exercise session includes both aerobic and resistance training targeting all major muscle groups (Additional document I, exercise program). The non-supervised group will exercise independently for 12 weeks according to the instructions given at the introductory lecture. The first control visit will be after this first period of 12 weeks of exercise.
After the first follow-up visit both group will continue non-supervised exercise for 12 weeks, after which the second control visit will be arranged. Special focus on the second control visit is to see how many in each group has been able to carry on active exercising, i.e. has the intervention promoted long-term change in exercise activity.
Both study group will be given Polar wrist activity monitors to be used 24 h/day for the entire course of the study.
All participants are asked to fill validated quality of life surveys EORTC QLQC-30 (overall quality of life) and EORTC QLQC-PR25 (prostate cancer-specific quality of life) at baseline and again at 1st and 2nd control visits. Additionally, qualitative evaluation of quality of life as well as perceived possibilities and obstacles for exercise are evaluated in individual- and group interviews during the study visits. Plasma lipid and glucose parameters, blood pressure and body composition will be measured at each of these visits.
At each visit a separate blood sample is taken and stored for future measurement of biomarkers associated with prostate cancer progression, glucose and lipid metabolism and effects of exercise.
- Conditions
- Prostate Cancer
- Being tested
- Progressive supervised weight training, Lecture
- Keywords
- androgen deprivation therapy, exercise, quality of life, blood glucose, cholesterol, prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive supervised weight trainingOther
12 weeks of progressive weight training twice a week supervised by a qualified physiotherapist.
LectureOther
Urologist informs participants on adverse effects of castration treatments and benefits of regular exercise. Physiotherapist gives an exercise program to follow at home, and nutritionist informs patients on correct nutrition to assist physical exercise.
| Study group | Role | What they receive |
|---|---|---|
| Supervised exercise arm | Experimental | Informational initiation lecture and supervised exercise twice a week for 12 weeks followed by 12 weeks of non-supervised exercise. Receives: Other: Progressive supervised weight training; Other: Lecture |
| Non-supervised exercise arm | Active comparator | Informational initiation lecture and only non-supervised exercise Receives: Other: Lecture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily total activity
Daily activity as measured by wrist activity monitor worn by the participants at all times during the study. Measured as metabolic equivalents of task (MET) units. Range from 0.9 to 23.
Measured: At randomization and twice more at 12 week intervals
Fasting plasma total cholesterol
Value measure in mmol/l
Measured: At randomization and twice more at 12 week intervals
Fasting plasma LDL cholesterol
Value measure in mmol/l
Measured: At randomization and twice more at 12 week intervals
Fasting plasma HDL cholesterol
Value measure in mmol/l
Measured: At randomization and twice more at 12 week intervals
Fasting plasma triglycerides
Value measure in mmol/l
Measured: At randomization and twice more at 12 week intervals
Fasting plasma glucose level
Value measured in mmol/l
Measured: At randomization and twice more at 12 week intervals
Blood glycated hemoglobin (HbA1C) level
Value measured in mmol/mol
Measured: At randomization and twice more at 12 week intervals
Overall quality of life
Score from validated survey EORTC QLQ-C30, score range from 0-100, with 100 denoting the highest quality of life
Measured: At randomization and twice more at 12 week intervals
Prostate cancer-specific quality of life
Score from validated survey EORTC QLQ-PR25, score range from 0-100, with 100 denoting the highest quality of life
Measured: At randomization and twice more at 12 week intervals
Secondary outcomes (9)
Change in daily activity after the intervention
Change in daily activity of the supervised exercise group after completion of 12 weeks of supervised exercise as measured by wrist activity monitor in MET units, range from 0.9 to 23.
Measured: Measured daily for 12 weeks' time after the intervention
Subjective adverse effects of castration treatment
The effect of supervised exercise on subjective adverse effects of castration treatment for prostate cancer. Qualitative assessment in three individual interviews and one group interview. No scaling used as this is a qualitative rather than quantitative end-point
Measured: At randomization and twice more at 12 week intervals
Lean body mass
Bioimpedance-based measurement of lean body mass as percentage of total body mass measured with TANITA MC-780 device
Measured: At randomization and twice more at 12 week intervals
Muscle mass
Bioimpedance-based measurement of muscle mass as percentage of total body mass measured with TANITA MC-780 device
Measured: At randomization and twice more at 12 week intervals
Skeletal mass
Bioimpedance-based measurement of skeletal mass as percentage of total body mass measured with TANITA MC-780 device measured with TANITA MC-780 device
Measured: At randomization and twice more at 12 week intervals
Fat mass
Bioimpedance-based measurement of fat mass as percentage of total body mass measured with TANITA MC-780 device measured with TANITA MC-780 device
Measured: At randomization and twice more at 12 week intervals
Metabolic age
Metabolic age measured with bioimpedance-based TANITA MC-780 device
Measured: At randomization and twice more at 12 week intervals
Systolic blood pressure
Value measured in mmHg
Measured: At randomization and twice more at 12 week intervals
Diastolic blood pressure
Value measured in mmHg
Measured: At randomization and twice more at 12 week intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start15 Aug 2019
- Primary completion15 Aug 2020 (estimated)
- Study completion15 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Tampere University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participant will be randomized 1:1 to either supervised exercise for 12 weeks or to follow given exercise program on their own.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Varalan urheiluopisto
- Responsible party
- Sponsor
- Investigators
- Teemu Murtola, MD PhD, Principal investigator, Tampereen University, Faculty of Medicine and Health Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050397
- Sponsor's protocol ID
- Patient School 1
- Status last verified
- Sep 2019
- First submitted
- 27 Jun 2018
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared since it is prohibited by the ethics board and by patient consent
Publications
Rantaniemi L, Jussila I, Siltari A, Ahtiainen JP, Hakulinen A, Harju E, Sormunen J, Nordstrom T, Tammela TLJ, Murtola TJ. Is Exercise During Androgen Deprivation Therapy Effective and Safe? A Randomized Controlled Trial. Scand J Med Sci Sports. 2025 Jun;35(6):e70084. doi: 10.1111/sms.70084.
PubMed 40481694
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intervention to Reduce Adverse Quality of Life Effects From Androgen Deprivation Therapy for Prostate Cancer - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04050397
- Acronym / sponsor ID
- Patient School 1
- Conditions
- Prostate Cancer
- Keywords
- androgen deprivation therapy, exercise, quality of life, blood glucose, cholesterol, prostate cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Varalan urheiluopisto
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 15 Aug 2021 (estimated)
- First posted
- 8 Aug 2019 (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 evaluates effects of supervised exercise in reducing adverse effects of hormonal treatment, increasing quality of life and in inducing a long-term change into more active lifestyle in prostate cancer patients on androgen deprivation therapy. All participants will attend a starting lecture at the beginning of the trial, after which they are randomly allocated to attend 3 months of either supervised or non-supervised exercise program. Leisure time activity, quality of life, blood sugar and cholesterol values, and body composition of participants will be evaluated at three time-points; at recruitment, after 12 weeks and after 24 weeks. Effects on quality of life will also be qualitatively evaluated with single- and group interviews.
Detailed description
Androgen deprivation therapy (ADT) is commonly used in management of advanced or recurrent prostate cancer. It also frequently used adjuvant to curative-intent radiation therapy for localized prostate cancer. Low testosterone levels during androgen deprivation commonly cause adverse effects reducing quality of life. Most common adverse effects include fatigue, weight gain, loss of lean muscle mass, hyperglycemia and hypercholesterolemia.
Regular exercise, especially programs involving combination of both aerobic exercise and resistance training has been shown to reduce to reduce adverse effects of ADT on physical functioning and quality of life. It may also improve disease prognosis.
The study compares effects of supervised and unsupervised exercise on plasma lipid parameters (total cholesterol, LDL, HDL and triglycerides) and glucose levels (fasting plasma glucose, glycated hemoglobin), overall quality of life and on average daily exercise activity in men with prostate cancer and under ADT. As secondary outcome we will study effect on continued exercise activity after the intervention, changes in body composition, blood pressure and risk of fractures, castration resistance as well as death due to prostate cancer and due to any cause.
Study hypothesis is that supervised exercise will improve quality of life, lipid and glucose parameters and increase daily exercise activity more that non-supervised exercise. We also expect higher continued exercise activity, greater changes in body composition and blood pressure and lowered risk of fractures and death in the supervised exercise group.
This is a randomized, controlled clinical trial. The study aims to recruit 40 men on ADT for prostate cancer. This will be a pilot study to estimate effect sizes in Finnish population to inform further larger trial.
All participants attend introductory lecture, where a urologist informs them about adverse effects of ADT and positive effects of exercise during ADT, exercise instructor gives advice for training both at home and in the gym and nutritional therapeutist tells about nutrition to overcome adverse effects of ADT and support training.
After the introductory lecture the participants are randomized 1:1 to either the supervised or non-supervised exercise group (Figure). Men in the supervised group participate in progressive group exercise sessions twice a week for total of 12 weeks at the Varala sports academy in Tampere, Finland. Each exercise session includes both aerobic and resistance training targeting all major muscle groups (Additional document I, exercise program). The non-supervised group will exercise independently for 12 weeks according to the instructions given at the introductory lecture. The first control visit will be after this first period of 12 weeks of exercise.
After the first follow-up visit both group will continue non-supervised exercise for 12 weeks, after which the second control visit will be arranged. Special focus on the second control visit is to see how many in each group has been able to carry on active exercising, i.e. has the intervention promoted long-term change in exercise activity.
Both study group will be given Polar wrist activity monitors to be used 24 h/day for the entire course of the study.
All participants are asked to fill validated quality of life surveys EORTC QLQC-30 (overall quality of life) and EORTC QLQC-PR25 (prostate cancer-specific quality of life) at baseline and again at 1st and 2nd control visits. Additionally, qualitative evaluation of quality of life as well as perceived possibilities and obstacles for exercise are evaluated in individual- and group interviews during the study visits. Plasma lipid and glucose parameters, blood pressure and body composition will be measured at each of these visits.
At each visit a separate blood sample is taken and stored for future measurement of biomarkers associated with prostate cancer progression, glucose and lipid metabolism and effects of exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participant will be randomized 1:1 to either supervised exercise for 12 weeks or to follow given exercise program on their own.
| Arm | Type | Receives |
|---|---|---|
| Supervised exercise arm | Experimental | Other: Progressive supervised weight training, Other: LectureInformational initiation lecture and supervised exercise twice a week for 12 weeks followed by 12 weeks of non-supervised exercise. |
| Non-supervised exercise arm | Active comparator | Other: LectureInformational initiation lecture and only non-supervised exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing castration treatment for prostate cancer
- Informed consent for the study
Key exclusion criteria (3 listed)
- Unable to participate in exercise (ECOG 2 or greater)
- High bone fracture risk (as judged by the primary physician)
- Unable to understand spoken and written instructions in Finnish
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 |
|---|---|---|
| Progressive supervised weight training12 weeks of progressive weight training twice a week supervised by a qualified physiotherapist. | Other | Supervised exercise arm |
| LectureUrologist informs participants on adverse effects of castration treatments and benefits of regular exercise. Physiotherapist gives an exercise program to follow at home, and nutritionist informs patients on correct nutrition to assist physical exercise. | Other | Non-supervised exercise arm, Supervised exercise arm |
Primary outcome
Daily total activity
Time frame: At randomization and twice more at 12 week intervals
Daily activity as measured by wrist activity monitor worn by the participants at all times during the study. Measured as metabolic equivalents of task (MET) units. Range from 0.9 to 23.
Fasting plasma total cholesterol
Time frame: At randomization and twice more at 12 week intervals
Value measure in mmol/l
Fasting plasma LDL cholesterol
Time frame: At randomization and twice more at 12 week intervals
Value measure in mmol/l
Fasting plasma HDL cholesterol
Time frame: At randomization and twice more at 12 week intervals
Value measure in mmol/l
Fasting plasma triglycerides
Time frame: At randomization and twice more at 12 week intervals
Value measure in mmol/l
Fasting plasma glucose level
Time frame: At randomization and twice more at 12 week intervals
Value measured in mmol/l
Blood glycated hemoglobin (HbA1C) level
Time frame: At randomization and twice more at 12 week intervals
Value measured in mmol/mol
Overall quality of life
Time frame: At randomization and twice more at 12 week intervals
Score from validated survey EORTC QLQ-C30, score range from 0-100, with 100 denoting the highest quality of life
Prostate cancer-specific quality of life
Time frame: At randomization and twice more at 12 week intervals
Score from validated survey EORTC QLQ-PR25, score range from 0-100, with 100 denoting the highest quality of life
9 secondary outcomes
Change in daily activity after the intervention
Time frame: Measured daily for 12 weeks' time after the intervention
Subjective adverse effects of castration treatment
Time frame: At randomization and twice more at 12 week intervals
Lean body mass
Time frame: At randomization and twice more at 12 week intervals
Muscle mass
Time frame: At randomization and twice more at 12 week intervals
Skeletal mass
Time frame: At randomization and twice more at 12 week intervals
Fat mass
Time frame: At randomization and twice more at 12 week intervals
Metabolic age
Time frame: At randomization and twice more at 12 week intervals
Systolic blood pressure
Time frame: At randomization and twice more at 12 week intervals
Diastolic blood pressure
Time frame: At randomization and twice more at 12 week intervals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Derived from this study: PubMed 40481694Rantaniemi L, Jussila I, Siltari A, Ahtiainen JP, Hakulinen A, Harju E, Sormunen J, Nordstrom T, Tammela TLJ, Murtola TJ. Is Exercise During Androgen Deprivation Therapy Effective and Safe? A Randomized Controlled Trial. Scand J Med Sci Sports. 2025 Jun;35(6):e70084. doi: 10.1111/sms.70084.
- Individual participant dataSharing planned: No. IPD will not be shared since it is prohibited by the ethics board and by patient consent
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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.
Teemu Murtola, MD PhD principal investigator
Tampereen University, Faculty of Medicine and Health Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive supervised weight training and Lecture in people with Prostate Cancer, run by Tampere University Hospital at 1 site in Finland.
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 2 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: status not confirmed, as of the sponsor's last update on 11 Sep 2019. 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 Finland. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teemu Murtola, MD PhD (+358 3 311 65015, teemu.murtola@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily total activity (time frame: At randomization and twice more at 12 week intervals). The study lists 9 primary outcomes in all. 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 NCT04050397, which also lists 1 linked publication.
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 11 Sep 2019.