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Behavioural Intervention

Exercise Training Intervention for Prostate Cancer (EXTRA-PC Trial)

Phase 1 & 2
Recruiting
Led By Alexander R Lucas, PhD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with stage II/III/IV prostate cancer
Currently undergoing treatment with ADT (intermittent or prolonged)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks, 24 weeks
Awards & highlights

EXTRA-PC Trial Summary

This trial aims to determine whether a home-based exercise program can help improve exercise capacity in prostate cancer patients compared to a group of patients receiving healthy living education. The effectiveness of the exercise program will be evaluated

Who is the study for?
This trial is for men aged 40-85 with stage II/III/IV prostate cancer, currently on ADT treatment, and who've completed curative-intent treatments like surgery or radiation. Participants must be able to use a computer or phone, speak English, and have no serious conditions that would make exercise unsafe.Check my eligibility
What is being tested?
The study compares the effects of a home-based exercise training program against healthy living education in improving physical fitness of prostate cancer patients. The focus is on whether exercise can boost peak oxygen intake and walking distance after 12 weeks.See study design
What are the potential side effects?
Since this trial involves an exercise intervention, potential side effects may include typical risks associated with physical activity such as muscle strains, joint pain, or fatigue. However, these are generally mild and manageable.

EXTRA-PC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with stage II, III, or IV prostate cancer.
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I am currently on hormone therapy for cancer.
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I have completed treatment aimed at curing my prostate cancer.
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I am between 41 and 85 years old.

EXTRA-PC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks, 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks, 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeks
Change from baseline in sub-maximal exercise capacity (6MWD) at 12 weeks
Secondary outcome measures
Arterial-venous oxygen (a-vO2) difference as a musculoskeletal determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.
Cardiac output (CO) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.
Change in Functional Assessment of Cancer Therapy - Prostate (FACT-P) scores
+19 more

EXTRA-PC Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise Training InterventionExperimental Treatment1 Intervention
The exercise program (ET) is tailored to each participant depending on his initial functional capacity, cardiorespiratory fitness and strength, to achieve ≥150 moderate to vigorous physical activity
Group II: Healthy Living Education ControlActive Control1 Intervention
Educational modules delivered remotely (or manual and telephone call) in a group-based setting to approximately match contact frequency and structure with the ET arm.

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Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
700 Previous Clinical Trials
22,886,760 Total Patients Enrolled
10 Trials studying Prostate Cancer
381 Patients Enrolled for Prostate Cancer
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,848 Previous Clinical Trials
47,818,202 Total Patients Enrolled
Alexander R Lucas, PhDPrincipal InvestigatorVirginia Commonwealth University
~40 spots leftby Jan 2028
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