Can exercise mechanically suppress tumour formation and growth in advanced prostate cancer patients with sclerotic bone metastases? Safety, feasibility and efficacy of a modular, multi-modal exercise program with spinal isometric training (M3EP-SIT).
- Conditions
- Prostate CancerBone MetastasesCancer - ProstatePhysical Medicine / Rehabilitation - Other physical medicine / rehabilitation
- Registration Number
- ACTRN12616000179437
- Lead Sponsor
- Edith Cowan University
- Brief Summary
Results are currently awaiting the final few patients to complete the study ( thus updated to be active, but not recruiting ). However, safety and feasibility can be comfortably provided (based on the currently completed patients ) highlighting that exercise delivery including targeted muscle activation exercise to spinal bone sclerotic lesions in advanced prostate cancer patients, is safe without any skeletal related adverse events or metastatic lesion degradation on-study. All other endpoints and outcomes will be assessed, analysed and reported through-out 2019 as the final patients complete; so batch analyses can occur, including for tumour morphology and tumour biomarkers for economy of scale.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 42
* Male, aged greater than or equal to 18 years.
* Histologically documented adenocarcinoma of the prostate.
* Stable solitary or multiple metastatic sclerotic lesions in the thoracic or lumbar spine.
* Greater than or equal to 3 months since last change of current primary therapies.
* Greater than or equal to 3 months since commencement of new primary therapies.
* Greater than or equal to 4 weeks since last major surgery and fully recovered
* Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 1
* Medical clearance by treating physician to participate in exercise
* Brain metastases or small cell neuroendocrine tumours’
* Currently receiving radiotherapy for thoracic or lumbar spinal metastases. Patients are permitted to receive radiotherapy for non-spinal bone metastases only during this intervention.
* Currently receiving any other experimental treatments or non-approved therapies.
* Regular participation in structured aerobic exercise greater than or equal to 2 days per week.
* Regular participation in structured resistance exercise greater than or equal to 2 days per week.
* Cardiovascular or neurological disorders that could inhibit exercise participation.
* Diminished legal or perceived psychological capacity to given informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method