Clinical trial NCT02481648: Feasibility of Measuring Exercise's Effects on Molecular Mechanisms of Disease Progression in Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Vancouver Prostate Centre
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 20
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion criteria:

* 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

Exclusion Criteria:

• Men with a medical, musculoskeletal condition or use of mobility aid that prevents participation in the exercise intervention.

Primary outcomes:
measure: Feasibility: Number of patients screened per month
timeFrame: From start of recruitment to end of recruitment
measure: Feasibility: Number of patients enrolled per month
timeFrame: From start of recruitment to end of recruitment
measure: Feasibility: Proportion of screen eligible patients who enroll
timeFrame: From start of recruitment to end of recruitment
measure: Feasibility: Treatment-specific retention rates
timeFrame: From date of randomization to end of treatment intervention for each participant, an average of 4-12 weeks
measure: Feasibility: Rates of adherence to protocol for the exercise intervention arm and control arm
timeFrame: From date of randomization to end of treatment intervention for each participant, an average of 4-12 weeks
measure: Feasibility: Proportion of planned assessments that are completed respectively
timeFrame: From date of randomization to end of study for each participant, an average of 7 months
Secondary outcomes:
measure: Physical Fitness: Godin Leisure-Time Exercise questionnaire (GLTEQ) and activity logs
timeFrame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
measure: Physical Fitness: Anthropometrics (i.e. BMI & waist circumference)
timeFrame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
measure: Physical Fitness: Aerobic fitness using a submaximal graded exercise test
timeFrame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
measure: Physical Fitness: Functional fitness using the 30-second chair stand and 30-second arm curl
timeFrame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
measure: Physical Fitness: Muscular strength test upper and lower extremity using the 1RM
timeFrame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
measure: Physical Fitness: Blood pressure and pulse
timeFrame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
measure: Biological: Collection of urine, blood, biopsy and RP specimens
timeFrame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
measure: Psychosocial: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P)
timeFrame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
measure: Psychosocial: Centre for Epidemiologic Studies Depression scale (CES-D)
timeFrame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
measure: Psychosocial: International Prostate Symptom Score (IPSS)
timeFrame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
measure: Psychosocial: International Index of Erectile Function scale (IIEF)
timeFrame: Baseline (month 0), pre-surgery (4-12 weeks) and 6-months post surgery
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Prostate Centre
state: British Columbia
Study officials:
affiliation: Department of Urologic Sciences, University of British Columbia
name: Peter Black, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.