Exercise program aims to protect hearts of black men on prostate cancer treatment
NCT ID NCT05327465
First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times
Summary
This study tests whether a 16-week, culturally tailored exercise program (aerobic and resistance training) can lower heart disease risk in Black men with prostate cancer who are receiving hormone therapy (androgen deprivation therapy). The study will enroll 62 participants, who will be randomly assigned to either the exercise program or usual care. Researchers will measure changes in heart risk scores, fitness, body composition, and quality of life.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 62 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2022
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must meet all criteria to be eligible, including travel to Dana-Farber Cancer Institute (DFCI) to collect research data to address the study question. * Over 18 years old; children under the age of 18 will be excluded due to the rarity of the disease * Histologically diagnosed of localized or metastatic prostate cancer * Have been receiving androgen deprivation therapy (ADT) (i.e., luteinizing hormone-releasing hormone \[LHRH\] agonist/antagonist and/or androgen receptor \[AR\] agonist/antagonist) for at least one month with a plan to continue ADT for at least 4 months at the time of recruitment * Self-identify as Black * Medically cleared to participate in exercise by their referred physician or a certified clinical exercise physiologist * Are without medical conditions that could exacerbate with exercise, such as bone disease (excluding bone metastases) at imminent risk of fracture or uncontrolled cardiopulmonary or metabolic diseases * Speak English and/or Spanish * Currently participate in less than or equal to 60 minutes of moderate or vigorous structured exercise/week * Willing to travel to DFCI for necessary data collection * Ability to communicate and complete written forms in English and/or Spanish Exclusion Criteria: * Are not receiving ADT (i.e., LHRH agonist/antagonist and/or AR agonist/antagonist) * Pre-existing medical conditions such as uncontrolled cardiopulmonary disease, or metabolic diseases that could exacerbate with exercise * Are not English or Spanish speaking * Patients with secondary diagnosis (with the exception of basal cell carcinoma) * Participate in more than 60 minutes of moderate or vigorous structured exercise/week * Unable to travel to DFCI for necessary data collection * May not be able to comply with the safety monitoring requirements of the study in the opinion of the investigator.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dana Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New PET tracer aims to light up hidden cancer targets
- Can daily adaptive radiotherapy spare healthy tissue in prostate cancer?
- Can a radioactive tracer and MRI reveal prostate Cancer's true extent?
- Five-Fraction radiation plus hormone therapy tested against High-Risk prostate cancer
- Can a 10-Hour eating window fight cancer fatigue?