Prostate CancerPhase 1/2EXTRA-PCNCT06237179
Behavioral Exercise Training to Reduce Cardiovascular Disease Risk
A Phase 1/2 study testing Exercise Training Intervention and Healthy Living Education in people with Prostate Cancer and Supportive Care, run by Virginia Commonwealth University at 2 sites in United States.
Trial summary
To test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak \& 6-minute walk distance [6MWD]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 weeks. Read more about this study
- Who is it for?
- Ages 40 to 85 years, men only
- Conditions the study is for
- Prostate Cancer, Supportive Care
- What is being tested?
- Exercise Training Intervention and Healthy Living Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Feb 2024to 31 Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 40 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be diagnosed with stage II/III/IV prostate cancer
- Be currently undergoing treatment with ADT (intermittent or prolonged)
- Have completed local curative-intent treatment, including prostatectomy or definitive radiation;
- Be >40 years of age up to 85;
- Be willing to sign an informed consent with HIPAA authorization form;
- Not have any hearing or sight impairments that result in the inability to use the telephone or hear normal conversation;
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- Must be able to join an intervention group by personal computer, smartphone or telephone call and should agree to recording of an interview;
- Be without any serious medical condition that precludes safe participation in an exercise program;
- Speak English
Who cannot join
- Be unable to undergo MRI (i.e., ferromagnetic materials in body, inability to lie flat, claustrophobia);
- Have contraindications to exercise testing;
- Have pre-existing overt cardiovascular disease/heart failure;
- Active illness/infection;
- Hemoglobin < 7.0 grams/dL
- Platelet count < 10 x 109/L
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Richmond Veterans Affairs Medical Center
Richmond, Virginia, 23249
Alexander R Lucas, PhD, 804-628-6610, Alexander.Lucas2@va.gov
Alexandra L Marshall, MS, 804 628-1215, lara.marshall@vcuhealth.org
- Recruiting
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
Alexandra Marshall, marshallla@vcu.edu
Alexander Lucas, PhD, 804-628-6610, Alexander.Lucas@vcuhealth.org
About this study
Official title: Behavioral Exercise Training to Reduce Cardiovascular Disease Risk in Men Undergoing Androgen Deprivation Therapy (EXTRA-PC)
To test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak \& 6-minute walk distance [6MWD]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 weeks.
- Conditions
- Prostate Cancer, Supportive Care
- Being tested
- Exercise Training Intervention, Healthy Living Education
- Keywords
- Prostate Cancer, Supportive Care, Exercise
- Medical subject headings
- Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Training InterventionBehavioural
Also called Behavioral, Exercise Training
5.1. The behavioral ET and HLE interventions will be delivered over 12 weeks. Before starting the study, men will be asked to attend one (1) in-person small group orientation to provide an overview of each intervention arm, familiarize them with web-based and smartphone applications or hard copy manuals for delivery of intervention content, exercise logs, resistance bands, and equipment for strength training.
Healthy Living EducationBehavioural
During the initial 12 weeks of the study, men randomized to the HLE group will receive 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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Training Intervention | Experimental | 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 Receives: Behavioral: Exercise Training Intervention |
| Healthy Living Education Control | Active comparator | 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. Receives: Behavioral: Healthy Living Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeks
Exercise capacity will be measured by the maximal volume of oxygen utilization (VO2 peak) during a supine graded cardiopulmonary exercise test done in conjunction with cardiac magnetic resonance (exeCMR+CPET). VO2 will be measured in both relative (ml/kg/minute) and absolute (L/minute) terms.
Measured: Baseline, 12 weeks, and 24 weeks
Change from baseline in sub-maximal exercise capacity (6MWD) at 12 weeks
The distance walked in a sub-maximal 6-minute walk test (6MWD). 6MWD will be reported as meters walked (m).
Measured: Baseline, 12 weeks, and 24 weeks
Secondary outcomes (22)
Stroke Volume (SV) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.
By measuring resting and exercise -associated left ventricular (LV) end-diastolic (EDV) and end-systolic volumes (ESV) we will calculate stroke volume (SV) in milliliters/beat (ml).
SV = EDV - ESV
Measured: Baseline, 12 weeks
Left ventricular ejection fraction (LVEF) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.
By measuring resting and exercise-associated stroke volumes (SV) as a proportion of end-diastolic volumes (EDV) we will calculate left ventricular ejection fraction (%).
LVEF = SV/EDV
Measured: Baseline, 12 weeks
Cardiac output (CO) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.
By measuring resting and exercise-associated stroke volume (SV) and the heart rate (HR) in conjunction with image acquisition we will calculate cardiac output in liters per minute (L/min).
CO = SV x HR
Measured: Baseline, 12 weeks
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.
From the exercise tests we will calculate a-vO2 difference using the FICK equation. The difference in oxygen saturation between the venous circulation and the arterial circulation will be reported in milliliters (ml) and also expressed as ml/100ml of blood (%)
a-vO2 = VO2 / CO
Measured: Baseline, 12 weeks
Change in lean body mass
We will conduct body composition assessments using bioelectrical impedance analysis (BIA) and a Dual Energy X-Ray Absorptiometry (DXA) scan. We will use dual X-ray absorptiometry (DEXA) to assess whole body composition for lean body mass.
Lean body mass will be reported as kilograms (kg)
Measured: Baseline, 12 weeks
Change in fat mass
We will conduct body composition assessments using bioelectrical impedance analysis (BIA) and a Dual Energy X-Ray Absorptiometry (DXA) scan. We will use dual X-ray absorptiometry (DEXA) to assess whole body composition for fat mass as well as distribution patterns of adiposity, e.g., visceral adipose tissue.
Fat mass and visceral fat mass will be reported in kilograms (kg) and body fat percentage will be reported as fat mass / body mass (%)
Measured: Baseline, 12 weeks
Neighborhood Environment & Walkability Survey (NEWS-A)
NEWS-A is a validated self-reported survey used to assess factors that are correlates or determinants of participants ability to engage in physical activity in their neighborhoods. For example, higher walkability is determined by availability of sidewalks and access to nearby facilities.
Measured: Baseline, 12 weeks, 24 weeks
Change in physical activity assessed with the Godin Leisure-Time Exercise Questionnaire (GLTEQ)
GLTEQ is a self-report survey to determine the level typical activity a participant engages in each week. Higher scores on the index indicate more activity.
Measured: Baseline, 12 weeks, 24 weeks
Change in physical activity assessed with Accelerometry
The ActivPAL and Actigraph accelerometers provide an objective assessment of sedentary sitting time and increasing intensities of physical activity in minutes per week
Measured: Baseline, 12 weeks, 24 weeks
Change in self-efficacy to navigate barriers to engaging in exercise
A self report of self-efficacy to engage in exercise or physical activity under different challenging conditions such as when experiencing fatigue. Higher scores indicate increased confidence to navigate barriers.
Measured: Baseline, 12 weeks, 24 weeks
Change in self-efficacy to walk for increasing periods of time.
A self report of self-efficacy to engage in walking for an increasing period of time. Higher scores indicate increased confidence to walk for a longer periods of time without resting.
Measured: Baseline, 12 weeks, 24 weeks
Change in Functional Assessment of Cancer Therapy - Prostate (FACT-P) scores
FACT-P is a validated self report measures of different domains of quality of life that are important for men who have been diagnosed with prostate cancer. Subscale scores can be assessed to gauge functional wellbeing, physical wellbeing, social wellbeing and emotional wellbeing as well as prostate specific wellbeing. Higher scores indicate a higher quality of life on overall and sub scales.
Measured: Baseline, 12 weeks, 24 weeks
Change in health-related quality of life (SF-36) scores
SF-36 (RAND) is a validated self report measure of different domains of health-related quality of life that are important for adults. Higher scores indicate a higher health-related quality of life .
Measured: Baseline, 12 weeks, 24 weeks
Change in fatigue measured with the patient reported outcomes measurement information system (PROMIS) - Fatigue scores
PROMIS - Fatigue is a validated self-report measure of fatigue among patients diagnosed with cancer and higher scores indicate a lower level of fatigue.
Measured: Baseline, 12 weeks, 24 weeks
Change in physical function measured with the patient reported outcomes measurement information system (PROMIS) - Physical Functioning scores
PROMIS - Physical Functioning is a validated self-report measure of physical functioning among patients diagnosed with cancer and higher scores indicate a better function.
Measured: Baseline, 12 weeks, 24 weeks
Change in sleep disturbance measured with the patient reported outcomes measurement information system (PROMIS) - Sleep Disturbance scores
PROMIS - Sleep Disturbance is a validated self-report measure of sleep disturbance among patients diagnosed with cancer and higher scores indicate less sleep disruption.
Measured: Baseline, 12 weeks, 24 weeks
Change in depressive symptoms measured with the patient reported outcomes measurement information system (PROMIS) - Depression scores
PROMIS - Depression is a validated self-report measure of depressive symptoms among patients diagnosed with cancer and higher scores indicate less symptoms.
Measured: Baseline, 12 weeks, 24 weeks
Change in anxiety measured with the patient reported outcomes measurement information system (PROMIS) - Anxiety scores
PROMIS - Anxiety is a validated self-report measure of depressive symptoms among patients diagnosed with cancer and higher scores indicate less symptoms.
Measured: Baseline, 12 weeks, 24 weeks
Change in emotional distress measured with the patient reported outcomes measurement information system (PROMIS) - Emotional Distress scores
PROMIS - Anxiety is a validated self-report measure of depressive symptoms among patients diagnosed with cancer and higher scores indicate less symptoms.
Measured: Baseline, 12 weeks, 24 weeks
Change in fatigue measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale
FACUT-F is a validated self-report measure of fatigue among patients undergoing treatment for a chronic illness and higher scores indicate less fatigue.
Measured: Baseline, 12 weeks, 24 weeks
Change in perceived stress as measured with Cohen's perceived stress scale (PSS)
PSS is a validated self-report measure of perceived stress and higher scores indicate more perceived stress.
Measured: Baseline, 12 weeks, 24 weeks
Change in physical function assessed with the Short Physical Performance Battery (SPPB)
SPPB is a validated objective assessment of 3 domains of physical function that includes gait speed, grip strength and time taken to stand from a chair 5 times. Each down is scored on a scale of 0-4 with a total score summed from each domain. A higher score is indicative of better functioning.
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start21 Feb 2024
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Alexander R Lucas, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237179
- Sponsor's protocol ID
- MCC-23-20934
- Other IDs
- HM20028583, 1K01HL161419-01A1
- Acronym
- EXTRA-PC
- Status last verified
- Feb 2026
- First submitted
- 4 Jan 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Exercise Training to Reduce Cardiovascular Disease Risk in Men Undergoing Androgen Deprivation Therapy (EXTRA-PC)
- ClinicalTrials.gov ID
- NCT06237179
- Acronym / sponsor ID
- EXTRA-PC / MCC-23-20934
- Conditions
- Prostate Cancer, Supportive Care
- Keywords
- Prostate Cancer, Supportive Care, Exercise
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 1 Feb 2024 (actual)
- 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.
To test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak \& 6-minute walk distance [6MWD]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Training Intervention | Experimental | Behavioral: Exercise Training InterventionThe 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 |
| Healthy Living Education Control | Active comparator | Behavioral: Healthy Living EducationEducational modules delivered remotely (or manual and telephone call) in a group-based setting to approximately match contact frequency and structure with the ET arm. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be diagnosed with stage II/III/IV prostate cancer
- Be currently undergoing treatment with ADT (intermittent or prolonged)
- Have completed local curative-intent treatment, including prostatectomy or definitive radiation;
- Be >40 years of age up to 85;
- Be willing to sign an informed consent with HIPAA authorization form;
Key exclusion criteria (6 listed)
- Be unable to undergo MRI (i.e., ferromagnetic materials in body, inability to lie flat, claustrophobia);
- Have contraindications to exercise testing;
- Have pre-existing overt cardiovascular disease/heart failure;
- Active illness/infection;
- Hemoglobin < 7.0 grams/dL
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 Training InterventionAlso: Behavioral, Exercise Training5.1. The behavioral ET and HLE interventions will be delivered over 12 weeks. Before starting the study, men will be asked to attend one (1) in-person small group orientation to provide an overview of each intervention arm, familiarize them with web-based and smartphone applications or hard copy manuals for delivery of intervention content, exercise logs, resistance bands, and equipment for strength training. | Behavioural | Exercise Training Intervention |
| Healthy Living EducationDuring the initial 12 weeks of the study, men randomized to the HLE group will receive 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. | Behavioural | Healthy Living Education Control |
Primary outcome
Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeks
Time frame: Baseline, 12 weeks, and 24 weeks
Exercise capacity will be measured by the maximal volume of oxygen utilization (VO2 peak) during a supine graded cardiopulmonary exercise test done in conjunction with cardiac magnetic resonance (exeCMR+CPET). VO2 will be measured in both relative (ml/kg/minute) and absolute (L/minute) terms.
Change from baseline in sub-maximal exercise capacity (6MWD) at 12 weeks
Time frame: Baseline, 12 weeks, and 24 weeks
The distance walked in a sub-maximal 6-minute walk test (6MWD). 6MWD will be reported as meters walked (m).
22 secondary outcomes
Stroke Volume (SV) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.
Time frame: Baseline, 12 weeks
Left ventricular ejection fraction (LVEF) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.
Time frame: Baseline, 12 weeks
Cardiac output (CO) as a cardiac determinant of exercise capacity among men undergoing ADT following 12 weeks of ET vs HLE controls.
Time frame: Baseline, 12 weeks
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.
Time frame: Baseline, 12 weeks
Change in lean body mass
Time frame: Baseline, 12 weeks
Change in fat mass
Time frame: Baseline, 12 weeks
Neighborhood Environment & Walkability Survey (NEWS-A)
Time frame: Baseline, 12 weeks, 24 weeks
Change in physical activity assessed with the Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Time frame: Baseline, 12 weeks, 24 weeks
Change in physical activity assessed with Accelerometry
Time frame: Baseline, 12 weeks, 24 weeks
Change in self-efficacy to navigate barriers to engaging in exercise
Time frame: Baseline, 12 weeks, 24 weeks
Change in self-efficacy to walk for increasing periods of time.
Time frame: Baseline, 12 weeks, 24 weeks
Change in Functional Assessment of Cancer Therapy - Prostate (FACT-P) scores
Time frame: Baseline, 12 weeks, 24 weeks
Change in health-related quality of life (SF-36) scores
Time frame: Baseline, 12 weeks, 24 weeks
Change in fatigue measured with the patient reported outcomes measurement information system (PROMIS) - Fatigue scores
Time frame: Baseline, 12 weeks, 24 weeks
Change in physical function measured with the patient reported outcomes measurement information system (PROMIS) - Physical Functioning scores
Time frame: Baseline, 12 weeks, 24 weeks
Change in sleep disturbance measured with the patient reported outcomes measurement information system (PROMIS) - Sleep Disturbance scores
Time frame: Baseline, 12 weeks, 24 weeks
Change in depressive symptoms measured with the patient reported outcomes measurement information system (PROMIS) - Depression scores
Time frame: Baseline, 12 weeks, 24 weeks
Change in anxiety measured with the patient reported outcomes measurement information system (PROMIS) - Anxiety scores
Time frame: Baseline, 12 weeks, 24 weeks
Change in emotional distress measured with the patient reported outcomes measurement information system (PROMIS) - Emotional Distress scores
Time frame: Baseline, 12 weeks, 24 weeks
Change in fatigue measured with the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scale
Time frame: Baseline, 12 weeks, 24 weeks
Change in perceived stress as measured with Cohen's perceived stress scale (PSS)
Time frame: Baseline, 12 weeks, 24 weeks
Change in physical function assessed with the Short Physical Performance Battery (SPPB)
Time frame: Baseline, 12 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Alexander R Lucas, PhD principal investigator
Virginia Commonwealth University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Exercise Training Intervention and Healthy Living Education in people with Prostate Cancer and Supportive Care, run by Virginia Commonwealth University at 2 sites in United States.
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 9 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander R Lucas, PhD (804 628-6610, Alexander.Lucas@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in maximal exercise capacity (VO2 peak) at 12 weeks (time frame: Baseline, 12 weeks, and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2026.