Prostate CancerEMMPCNCT02481648
Feasibility of Measuring Exercise's Effects on Molecular Mechanisms of Disease Progression in Prostate Cancer
A study testing Exercise in people with Prostate Cancer, run by Vancouver Prostate Centre at 1 site in Canada.
Trial summary
The investigators aim to evaluate the feasibility of a larger clinical trial assessing an exercise program during the "teachable moment" in patients with prostate cancer and measuring its effect on tumor apoptosis signaling, lipogenesis and steroidogenesis. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Dec 2024
- 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 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed Pre-Screening Consent Form
- Men with CaP, who are deemed suitable by a urologist for RP
- Engaging in <90 minutes/week of moderate-to-vigorous exercise
- BMI <40
- Age >19
- Able to speak and read English (to be able to complete questionnaires)
- Willing to comply with all study procedures (including committing to twice-weekly visits to the study exercise facility and exercise at home) and be available for the duration of the study
- Provide signed and dated informed consent form
Who cannot join
- Men with a medical, musculoskeletal condition or use of mobility aid that prevents participation in the exercise intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate Feasibility of Measuring Exercise's Effects on Molecular Mechanisms of Disease Progression in Newly Diagnosed Prostate Cancer Patients Undergoing Radical Prostatectomy
The investigators aim to evaluate the feasibility of a larger clinical trial assessing an exercise program during the "teachable moment" in patients with prostate cancer and measuring its effect on tumor apoptosis signaling, lipogenesis and steroidogenesis. Participants will be randomized between a 4-12 week exercise program or to standard of care only. Participants will be assessed at screening, baseline (day 0), throughout the trial intervention (days 1-84), post-intervention visit (prior to radical prostatectomy) and final study visit 6-months post-radical prostatectomy. At each assessment, physical, biological samples and psychosocial assessments will take place.
- Conditions
- Prostate Cancer
- Being tested
- Exercise
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
| Study group | Role | What they receive |
|---|---|---|
| ARM1: Exercise Intervention | Experimental | The exercise program is a 4-12 weeks progressive combined resistance and aerobic exercise for participants from time of diagnosis to RP.
Participants will undergo twice weekly group-training (four-six participants/group) combined aerobic-resistance sessions (1hr per session), supervised by trained exercise therapists. In addition, participants will undergo home-based aerobic exercise independently three times a week with the goal to meet the current physical activity guidelines for cancer survivors (150min/week of moderate intensity aerobic activity and two resistance training sessions per week). Participants will also be supplied with the Canadian Physical Activity and Sedentary Behavior Guidelines Handbook and accompanying Log Sheets. Receives: Other: Exercise |
| ARM2: Control Group | No intervention | Participants will be asked to exercise as they normally would and will be asked to record their exercise activity on provided activity logs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Number of patients screened per month
Measured: From start of recruitment to end of recruitment
Feasibility: Number of patients enrolled per month
Measured: From start of recruitment to end of recruitment
Feasibility: Proportion of screen eligible patients who enroll
Measured: From start of recruitment to end of recruitment
Feasibility: Treatment-specific retention rates
Measured: From date of randomization to end of treatment intervention for each participant, an average of 4-12 weeks
Feasibility: Rates of adherence to protocol for the exercise intervention arm and control arm
Measured: From date of randomization to end of treatment intervention for each participant, an average of 4-12 weeks
Feasibility: Proportion of planned assessments that are completed respectively
Measured: From date of randomization to end of study for each participant, an average of 7 months
Secondary outcomes (11)
Physical Fitness: Godin Leisure-Time Exercise questionnaire (GLTEQ) and activity logs
Comparison of activity at baseline, during the study and at the end of the study
Measured: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Physical Fitness: Anthropometrics (i.e. BMI & waist circumference)
Comparison of baseline versus end of study anthropometrics
Measured: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Physical Fitness: Aerobic fitness using a submaximal graded exercise test
Comparison of baseline versus end of study aerobic fitness
Measured: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Physical Fitness: Functional fitness using the 30-second chair stand and 30-second arm curl
Comparison of baseline versus end of study functional fitness
Measured: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Physical Fitness: Muscular strength test upper and lower extremity using the 1RM
Comparison of baseline versus end of study muscular strength
Measured: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Physical Fitness: Blood pressure and pulse
Comparison of baseline versus end of study blood pressure and pulse
Measured: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Biological: Collection of urine, blood, biopsy and RP specimens
Ability to collect these samples for each participant will be assessed
Measured: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Psychosocial: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P)
Comparison of questionnaire scores at baseline versus end of study
Measured: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Psychosocial: Centre for Epidemiologic Studies Depression scale (CES-D)
Comparison of questionnaire scores at baseline versus end of study
Measured: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Psychosocial: International Prostate Symptom Score (IPSS)
Comparison of questionnaire scores at baseline versus end of study
Measured: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Psychosocial: International Index of Erectile Function scale (IIEF)
Comparison of questionnaire scores at baseline versus end of study
Measured: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2018
- Study completionDec 2024 (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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vancouver Prostate Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Black, MD, Principal investigator, Department of Urologic Sciences, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481648
- Sponsor's protocol ID
- EMMPC
- Acronym
- EMMPC
- Status last verified
- Apr 2023
- First submitted
- 27 Jan 2015
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Schulz GB, Locke JA, Campbell KL, Bland KA, Van Patten CL, Black PC, Goldenberg SL, Flannigan R. Taking Advantage of the Teachable Moment at Initial Diagnosis of Prostate Cancer-Results of a Pilot Randomized Controlled Trial of Supervised Exercise Training. Cancer Nurs. 2022 May-Jun 01;45(3):E680-E688. doi: 10.1097/NCC.0000000000001013. Epub 2022 Jan 14.
PubMed 34608048
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate Feasibility of Measuring Exercise's Effects on Molecular Mechanisms of Disease Progression in Newly Diagnosed Prostate Cancer Patients Undergoing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02481648
- Acronym / sponsor ID
- EMMPC / EMMPC
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vancouver Prostate CentreUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 25 Jun 2015 (estimated)
- 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.
The investigators aim to evaluate the feasibility of a larger clinical trial assessing an exercise program during the "teachable moment" in patients with prostate cancer and measuring its effect on tumor apoptosis signaling, lipogenesis and steroidogenesis. Participants will be randomized between a 4-12 week exercise program or to standard of care only. Participants will be assessed at screening, baseline (day 0), throughout the trial intervention (days 1-84), post-intervention visit (prior to radical prostatectomy) and final study visit 6-months post-radical prostatectomy. At each assessment, physical, biological samples and psychosocial assessments will take place.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM1: Exercise Intervention | Experimental | Other: ExerciseThe exercise program is a 4-12 weeks progressive combined resistance and aerobic exercise for participants from time of diagnosis to RP. Participants will undergo twice weekly group-training (four-six participants/group) combined aerobic-resistance sessions (1hr per session), supervised by trained exercise therapists. In addition, participants will undergo home-based aerobic exercise independently three times a week with the goal to meet the current physical activity guidelines for cancer survivors (150min/week of moderate intensity aerobic activity and two resistance training sessions per week). Participants will also be supplied with the Canadian Physical Activity and Sedentary Behavior Guidelines Handbook and accompanying Log Sheets. |
| ARM2: Control Group | No intervention | –Participants will be asked to exercise as they normally would and will be asked to record their exercise activity on provided activity logs. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Completed Pre-Screening Consent Form
- Men with CaP, who are deemed suitable by a urologist for RP
- Engaging in <90 minutes/week of moderate-to-vigorous exercise
- BMI <40
- Age >19
Key exclusion criteria (1 listed)
- Men with a medical, musculoskeletal condition or use of mobility aid that prevents participation in the exercise intervention.
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 |
|---|---|---|
| Exercise | Other | ARM1: Exercise Intervention |
Primary outcome
Feasibility: Number of patients screened per month
Time frame: From start of recruitment to end of recruitment
Feasibility: Number of patients enrolled per month
Time frame: From start of recruitment to end of recruitment
Feasibility: Proportion of screen eligible patients who enroll
Time frame: From start of recruitment to end of recruitment
Feasibility: Treatment-specific retention rates
Time frame: From date of randomization to end of treatment intervention for each participant, an average of 4-12 weeks
Feasibility: Rates of adherence to protocol for the exercise intervention arm and control arm
Time frame: From date of randomization to end of treatment intervention for each participant, an average of 4-12 weeks
Feasibility: Proportion of planned assessments that are completed respectively
Time frame: From date of randomization to end of study for each participant, an average of 7 months
11 secondary outcomes
Physical Fitness: Godin Leisure-Time Exercise questionnaire (GLTEQ) and activity logs
Time frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Physical Fitness: Anthropometrics (i.e. BMI & waist circumference)
Time frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Physical Fitness: Aerobic fitness using a submaximal graded exercise test
Time frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Physical Fitness: Functional fitness using the 30-second chair stand and 30-second arm curl
Time frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Physical Fitness: Muscular strength test upper and lower extremity using the 1RM
Time frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Physical Fitness: Blood pressure and pulse
Time frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Biological: Collection of urine, blood, biopsy and RP specimens
Time frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Psychosocial: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P)
Time frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Psychosocial: Centre for Epidemiologic Studies Depression scale (CES-D)
Time frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Psychosocial: International Prostate Symptom Score (IPSS)
Time frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Psychosocial: International Index of Erectile Function scale (IIEF)
Time frame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Derived from this study: PubMed 34608048Schulz GB, Locke JA, Campbell KL, Bland KA, Van Patten CL, Black PC, Goldenberg SL, Flannigan R. Taking Advantage of the Teachable Moment at Initial Diagnosis of Prostate Cancer-Results of a Pilot Randomized Controlled Trial of Supervised Exercise Training. Cancer Nurs. 2022 May-Jun 01;45(3):E680-E688. doi: 10.1097/NCC.0000000000001013. Epub 2022 Jan 14.
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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.
Peter Black, MD principal investigator
Department of Urologic Sciences, University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Prostate Cancer, run by Vancouver Prostate Centre at 1 site in Canada.
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 8 inclusion and 1 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 19 Apr 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 Canada. 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?
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?
Feasibility: Number of patients screened per month (time frame: From start of recruitment to end of recruitment). The study lists 6 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 NCT02481648, 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 19 Apr 2023.