Prostate CancerNCT03440879
Androgen Deprivation Therapy Muscle Protein Metabolism and Blood Glucose
A study testing Zoladex in people with Prostate Cancer and Resistance Exercise, run by Norwegian School of Sport Sciences at 1 site in Norway.
Trial summary
Prostate cancer (PCa) patients receiving androgen deprivation therapy (ADT) (e.g., Zoladex), experience troublesome side effects during and after treatment (e.g., loss of lean body mass (LBM) and increased fat mass). Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer, Resistance Exercise, Androgen Deprivation Therapy
- What is being tested?
- Zoladex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteNorway
- Study dates
- 21 Sep 2018to 2 Mar 2023
- 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All of the following conditions must apply to the prospective patient at screening prior to participation:
- Histologically verified prostate cancer, and either currently on Zoladex or without any current or no past usage of any ADT
- Between 18 and 75 years of age
- Capable of reading and understanding Norwegian, and able to provide informed consent
- Treating oncologist/ study medical doctor´s (KMR) approval for participation
- Signed informed consent must be obtained and documented according to Good Clinical Practice (GCP), and national/local regulations.
Who cannot join
- Patients will be excluded from the study if they meet any of the following criteria:
- Routine resistance training (>1 weekly session, last six months)
- Treated with Warfarin, or if seponation of acetylsalicylic acid is not recommended
- Conditions where heavy resistance exercise is contraindicated:
- Unregulated hypertension
- Unstable angina pectoris
Show all 26Show fewer
- Recent myocardial infarction (<1 year)
- Cardiac arrhythmia
- Chronic obstructive pulmonary disease
- Severe asthma
- Recent stroke (<1 year)
- Epilepsy
- Insulin-dependent diabetes mellitus
- Unstable bone lesions with increased risk of fractures
- Conditions where patients ability to complete the training sessions is challenged:
- Uncontrolled pain
- Severe arthritis
- Scheduled hip or knee replacement
- Pathologic fractures last six months
- Amputations
- Walker or wheelchair user
- Mentally incompetent conditions:
- Severe anxiety or depression
- Dementia
- Known alcoholism or substance abuse
- Mentally retarded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Androgen Deprivation Therapy on Regulation of Muscle Protein Metabolism and Blood Glucose
Prostate cancer (PCa) patients receiving androgen deprivation therapy (ADT) (e.g., Zoladex), experience troublesome side effects during and after treatment (e.g., loss of lean body mass (LBM) and increased fat mass). Although the negative effects of ADT on muscle mass are well documented, the cellular effects of ADT on muscle tissue are still largely unknown, and studies investigating the mechanisms are highly warranted. Furthermore, understanding the cellular mechanisms through which ADT negatively influences muscle mass and glucose metabolism is important so that appropriate measures can be taken to counteract muscle wasting and comorbidities during ADT. Thus, PCa patients on ADT (Zoladex), along with non-ADT treated PCa patients serving as controls, will be invited to participate in this study, that aims to investigate the influence of ADT on the basal muscle protein turnover, as well as the responses to strength training. Secondary aims are to investigate between-group differences in blood glucose and insulin responses following a meal).
Read the detailed description
Prostate cancer (PCa) patients receiving androgen deprivation therapy (ADT) (e.g., Zoladex), which leads to castrate levels of testosterone, experience troublesome side effects during and after treatment. Commonly reported side effects are loss of lean body mass (LBM) and increased fat mass, as well as impaired glucose- and fat metabolism. Strength training has shown positive effects on LBM in PCa patients on ADT, however, counteracting a substantial LBM loss observed in the control groups seem to account for the intervention effect seen in several of the individual studies. Thus, the real LBM gain following strength training in PCa patients on ADT may be hampered compared to healthy elderly men, but data on this is limited in the literature.
The planned acute recovery study is a continuation of the physical exercise and prostate cancer (PEPC) trial, which was a randomized controlled trial investigating the effects of strength training on body composition, muscle strength, and muscle cellular outcomes during ADT.
Beyond locomotion and activity of daily living, the skeletal muscle tissue plays an important role in glucose metabolism, and impaired glucose uptake to the muscle is associated with diseases such as diabetes mellitus and cardiovascular diseases. In fact, increased levels of fasted blood glucose and insulin have been reported during the first year of ADT. Interestingly, insulin resistance has been noted as early as three months into the treatment. Insulin resistance may, in addition to the increased risk for metabolic comorbidities, also impair the anabolic response in muscles to feeding and exercise. Consequently, the accelerated muscle mass loss, and the potential limited response to strength training might be interlinked to the reduction in insulin sensitivity in PCa patients receiving ADT.
Although the negative effects of ADT on muscle mass are well documented, the cellular effects of ADT on muscle tissue are still largely unknown, and studies investigating the mechanisms are highly warranted. Furthermore, understanding the cellular mechanisms through which ADT negatively influences muscle mass and glucose metabolism is important so that appropriate measures can be taken to counteract muscle wasting and comorbidities during ADT. The present study is designed to address these issues.
PCa patients on ADT (Zoladex), along with non-ADT treated PCa patients serving as controls, will be invited to participate in this study. The aim is to investigate the influence of ADT on the basal muscle protein turnover, as well as the responses to strength training. Furthermore, secondary aims are to investigate between-group differences in blood glucose and insulin responses following a meal).
- Being tested
- Zoladex
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZoladexDrug
Also called Androgen deprivation therapy
Patients currently treated with Zoladex
| Study group | Role | What they receive |
|---|---|---|
| ADT group | Experimental | Prostate cancer patients currently receiving androgen deprivation therapy (Zoladex) Receives: Drug: Zoladex |
| No-ADT group | No intervention | Prostate cancer patients without any history of receiving any form of androgen deprivation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle protein synthesis rate
The protein synthesis rate will be calculated based on the increased enrichment of deuterium, which will be ingested the week prior to the acute day, in muscle protein isolated from muscle biopsies. Deuterium enrichment is assessed by mass spectrometry.
Measured: The muscle biopsy will be collected two hours after the last exercise session.
Secondary outcomes (4)
Muscle cell signalling
Changes in the activity of enzymes involved in anabolic- and catabolic signalling, as well as levels of key enzymes related to glucose metabolism, heat shock proteins, and indicators of autophagy capacity, will be analyzed by western blot according to standard operating procedures.
Measured: Muscle biopsies will be collected on the Acute day. Muscle biopsies obtained 3.5 (baseline biopsy) and 1 hours (post meal) prior to the last exercise session, and 2 hours (post exercise) after the last exercise session will be used
Plasma insulin levels
Will be collected in EDTA vacutainers through venous catheters, centrifuged and serum will be stored at -20ºC for later analysis. When serum from all patients has been collected, insulin levels will be analyzed.
Measured: A fasted blood sample will be collected first thing in the morning at the Acute day. Then again at 15, 30, 45, 60, 75, 90, 105, and 120 minutes post meal and post exercise.
Plasma glucose levels
Will be collected in EDTA vacutainers through venous catheters, centrifuged and serum will be stored at -20ºC for later analysis. When serum from all patients has been collected, glucose levels will be analyzed, along with other hormones and signaling molecules.
Measured: A fasted blood sample will be collected first thing in the morning at the Acute day. Then again at 15, 30, 45, 60, 75, 90, 105, and 120 minutes post meal and post exercise.
Ribosomal RNA
The expression of ribosomal RNAs (including the large subunit; 28S and 5.8S, and the small subunit; 18S) will be assessed by qPCR, to evaluate the translational capacity of the muscle. Also, the acute change in mRNA expression levels of growth factors (e.g. MGF, IGF-1), ubiquitin-proteasome system (e.g. murf-1 and Atrogin-1), genes involved in autophagy (e.g. LC3 and p62), and other testosterone sensitive genes will be analyzed.
Measured: Muscle biopsies will be obtained at the Acute day. Muscle biopsies for ribosomal RNA analysis will be obtained 3.5 hours prior to the last exercise session (baseline) and 2 hours post the last exercise session (post exercise)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start21 Sep 2018
- Primary completion2 Mar 2023
- Study completion2 Mar 2023
Why it stopped: Low recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus, Oslo University Hospital, Copenhagen University Hospital, Rigshospitalet, University of Copenhagen, King's College London
- Responsible party
- Principal investigator, Truls Raastad, Norwegian School of Sport Sciences
- Investigators
- Truls Raastad, Professor, Principal investigator, Norwegian School of Sport Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440879
- Sponsor's protocol ID
- PROST100
- Status last verified
- Mar 2023
- First submitted
- 1 Feb 2018
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Androgen Deprivation Therapy on Regulation of Muscle Protein Metabolism and Blood Glucose
- ClinicalTrials.gov ID
- NCT03440879
- Acronym / sponsor ID
- PROST100
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment rate
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Collaborators
- University Hospital, Akershus, Oslo University Hospital, Copenhagen University Hospital, Rigshospitalet, University of Copenhagen, King's College London
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 22 Feb 2018 (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.
Prostate cancer (PCa) patients receiving androgen deprivation therapy (ADT) (e.g., Zoladex), experience troublesome side effects during and after treatment (e.g., loss of lean body mass (LBM) and increased fat mass). Although the negative effects of ADT on muscle mass are well documented, the cellular effects of ADT on muscle tissue are still largely unknown, and studies investigating the mechanisms are highly warranted. Furthermore, understanding the cellular mechanisms through which ADT negatively influences muscle mass and glucose metabolism is important so that appropriate measures can be taken to counteract muscle wasting and comorbidities during ADT. Thus, PCa patients on ADT (Zoladex), along with non-ADT treated PCa patients serving as controls, will be invited to participate in this study, that aims to investigate the influence of ADT on the basal muscle protein turnover, as well as the responses to strength training. Secondary aims are to investigate between-group differences in blood glucose and insulin responses following a meal).
Detailed description
Prostate cancer (PCa) patients receiving androgen deprivation therapy (ADT) (e.g., Zoladex), which leads to castrate levels of testosterone, experience troublesome side effects during and after treatment. Commonly reported side effects are loss of lean body mass (LBM) and increased fat mass, as well as impaired glucose- and fat metabolism. Strength training has shown positive effects on LBM in PCa patients on ADT, however, counteracting a substantial LBM loss observed in the control groups seem to account for the intervention effect seen in several of the individual studies. Thus, the real LBM gain following strength training in PCa patients on ADT may be hampered compared to healthy elderly men, but data on this is limited in the literature.
The planned acute recovery study is a continuation of the physical exercise and prostate cancer (PEPC) trial, which was a randomized controlled trial investigating the effects of strength training on body composition, muscle strength, and muscle cellular outcomes during ADT.
Beyond locomotion and activity of daily living, the skeletal muscle tissue plays an important role in glucose metabolism, and impaired glucose uptake to the muscle is associated with diseases such as diabetes mellitus and cardiovascular diseases. In fact, increased levels of fasted blood glucose and insulin have been reported during the first year of ADT. Interestingly, insulin resistance has been noted as early as three months into the treatment. Insulin resistance may, in addition to the increased risk for metabolic comorbidities, also impair the anabolic response in muscles to feeding and exercise. Consequently, the accelerated muscle mass loss, and the potential limited response to strength training might be interlinked to the reduction in insulin sensitivity in PCa patients receiving ADT.
Although the negative effects of ADT on muscle mass are well documented, the cellular effects of ADT on muscle tissue are still largely unknown, and studies investigating the mechanisms are highly warranted. Furthermore, understanding the cellular mechanisms through which ADT negatively influences muscle mass and glucose metabolism is important so that appropriate measures can be taken to counteract muscle wasting and comorbidities during ADT. The present study is designed to address these issues.
PCa patients on ADT (Zoladex), along with non-ADT treated PCa patients serving as controls, will be invited to participate in this study. The aim is to investigate the influence of ADT on the basal muscle protein turnover, as well as the responses to strength training. Furthermore, secondary aims are to investigate between-group differences in blood glucose and insulin responses following a meal).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADT group | Experimental | Drug: ZoladexProstate cancer patients currently receiving androgen deprivation therapy (Zoladex) |
| No-ADT group | No intervention | –Prostate cancer patients without any history of receiving any form of androgen deprivation therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All of the following conditions must apply to the prospective patient at screening prior to participation:
- Histologically verified prostate cancer, and either currently on Zoladex or without any current or no past usage of any ADT
- Between 18 and 75 years of age
- Capable of reading and understanding Norwegian, and able to provide informed consent
- Treating oncologist/ study medical doctor´s (KMR) approval for participation
Key exclusion criteria (26 listed)
- Routine resistance training (>1 weekly session, last six months)
- Treated with Warfarin, or if seponation of acetylsalicylic acid is not recommended
- Conditions where heavy resistance exercise is contraindicated:
- Conditions where patients ability to complete the training sessions is challenged:
- Mentally incompetent conditions:
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 |
|---|---|---|
| ZoladexAlso: Androgen deprivation therapyPatients currently treated with Zoladex | Drug | ADT group |
Primary outcome
Muscle protein synthesis rate
Time frame: The muscle biopsy will be collected two hours after the last exercise session.
The protein synthesis rate will be calculated based on the increased enrichment of deuterium, which will be ingested the week prior to the acute day, in muscle protein isolated from muscle biopsies. Deuterium enrichment is assessed by mass spectrometry.
4 secondary outcomes
Muscle cell signalling
Time frame: Muscle biopsies will be collected on the Acute day. Muscle biopsies obtained 3.5 (baseline biopsy) and 1 hours (post meal) prior to the last exercise session, and 2 hours (post exercise) after the last exercise session will be used
Plasma insulin levels
Time frame: A fasted blood sample will be collected first thing in the morning at the Acute day. Then again at 15, 30, 45, 60, 75, 90, 105, and 120 minutes post meal and post exercise.
Plasma glucose levels
Time frame: A fasted blood sample will be collected first thing in the morning at the Acute day. Then again at 15, 30, 45, 60, 75, 90, 105, and 120 minutes post meal and post exercise.
Ribosomal RNA
Time frame: Muscle biopsies will be obtained at the Acute day. Muscle biopsies for ribosomal RNA analysis will be obtained 3.5 hours prior to the last exercise session (baseline) and 2 hours post the last exercise session (post exercise)
Results and safety
The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- 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. This study is not recruiting at the moment.
Truls Raastad, Professor principal investigator
Norwegian School of Sport Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zoladex in people with Prostate Cancer and Resistance Exercise, run by Norwegian School of Sport Sciences at 1 site in Norway.
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 26 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: stopped early, as of the sponsor's last update on 27 Mar 2023. 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 Norway. 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?
The study was stopped early (reason given: Low recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle protein synthesis rate (time frame: The muscle biopsy will be collected two hours after the last exercise session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.