Exercise for Advanced Prostate Cancer: a Multicomponent Feasibility Trial (EXACT)

Queen's University Belfast

Status: Completed

Conditions: Castration-resistant Prostate Cancer; Prostate Cancer Metastatic

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03658486

B18/15

Details and patient eligibility

About

This feasibility study will investigate whether men with metastatic prostate cancer can take part in and progress through a home-based exercise program. This study will evaluate the effects of exercise on a range of disease and treatment-related outcomes.

Full description

This 12 week multicomponent, tailored, progressive program will consist of both moderate intensity walking and strengthening exercises at home. This single centre, single arm study will incorporate a behavioural change consultation at baseline and weekly behavioural support throughout. This study will follow-up patients at 24 weeks to determine exercise maintenance. Outcome measures will be completed at baseline, 12 and 24 weeks. A qualitative evaluation will be conducted after the 24 week follow-up to determine impact, patient experience and measures that might assist in refining the program.

Enrollment: 30 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically documented adenocarcinoma of the prostate with progressive systemic metastatic disease despite castrate levels of testosterone (<50ng/dL).
• At enrolment, patients must have demonstrated progressive disease since the most recent change in therapy.
• Patients must be on ADT with a GnRH agonist/antagonist or prior bilateral orchiectomy. All patients must be on ADT during the study period.
• ≥ 4 weeks since last surgery and fully recovered.
• No known contraindications to moderate intensity exercise such as (but not limited to) brain metastases, acute congestive heart failure, unstable angina, serious or non-healing wound, peripheral neuropathy greater than or equal to Grade 3. Recent myocardial infarction.
• Age ≥ 18 years.
• ECOG performance status 0-2.
• Medical clearance by treating clinician.

Exclusion criteria

• Men currently exceeding ACSM recommended exercise guidelines (150 mins of moderate and/or 60 mins of high intensity exercise per week).
• Men with brain metastases.
• Men with a currently active second malignancy other than non-melanoma skin cancer.
• Congestive heart failure or recent serious cardiovascular event.
• Chest pain brought on by physical activity.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Exercise

Other group

Description:

12 weeks of progressive, home-based, moderate intensity, aerobic and strengthening exercise. Aerobic exercise will be completed 5 days per week, commencing with a single 10 minute bout and progressing to 30 minutes of continuous brisk walking at week 12. Strengthening exercises will involve whole body activities and commence with 1 set of each exercise (8-15 repetitions) and progress to 3 sets. The strengthening exercises will gradually progress in difficulty throughout the program.

Treatment:

Other: Exercise