Recruiting

Exercise

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT05327465

Conditions

Androgen Deprivation Therapy

Prostate Cancer

Prostate Cancer Metastatic

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aerobic and resistance exercise

Usual Care

Study Details

Brief summary:

The purpose of this research is to determine whether a 16-week culturally tailored, technology-based, aerobic and resistance exercise intervention improves cardiovascular risk factors in Black men diagnosed with prostate cancer and are undergoing androgen deprivation therapy (ADT), and whether it will also improve physical fitness and function, body composition, and outcomes such as quality of life, cancer symptoms, and self-esteem.

Participants in this study will be randomly assigned to one of two groups: 1) Aerobic and resistance exercise, or 2) Usual care.

Conditions

Androgen Deprivation Therapy

Prostate Cancer

Prostate Cancer Metastatic

Study ID

NCT05327465

Start date

Aug 11, 2022

Status verified date

Jan, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Aerobic and resistance exercise

Virtually supervised 16-week aerobic and resistance exercise performed at home via Zoom.

The exercises will be performed three times per week for 16 weeks, and virtually supervised by a professional exercise trainer.

active comparator: Usual care

Maintenance of baseline exercise levels for 16 weeks with an offer to perform the same exercise program after 16 weeks.

Interventions

Aerobic and resistance exercise

Perform exercise at home with virtual supervision, including aerobic exercise (e.g.,cycling), which can improve cardiovascular (heart) and lung function, and resistance exercise (e.g., dumbbell lifting and using resistance band. The exercises will be performed three times per week for 16 weeks, and virtually supervised by a professional exercise trainer

Usual Care

Maintenance of baseline exercise levels for 16 weeks with an offer to perform the same exercise (aerobic and resistance exercise) program after 16 weeks.

Primary outcome measure

  • Cardiovascular disease risk factors [ Time Frame: baseline to 4 months ]

Central Contacts and Locations

Central contacts

Christina Dieli-Conwright, PhD, MPH

617-632-3800ChristinaM_Dieli-Conwright@dfci.harvard.edu

Locations

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Christina Dieli-Conwright, PhD, MPH

617-632-3800ChristinaM_Dieli-Conwright@dfci.harvard.edu

Principal Investigator:

Christina Dieli-Conwright, PhD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Jul 29, 2026

Last verified

Jan, 2026

Keywords

  • Androgen deprivation therapy
  • Localized Prostate Cancer
  • Prostate Cancer Metastatic
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-07-29.