Recruiting

MultiComponent Exercise

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06040125

Conditions

PROSTATE CANCER

Metastatic Prostate Cancer

Metastatic Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Supervised Circuit Training

Study Details

Brief summary:

The purpose of this study is to determine whether a 16-week supervised, clinic-based circuit training intervention utilizing resistance and functional exercises and self-directed aerobic exercise will improve frailty and sarcopenic status and disease progression outcomes among pre-frail/frail metastatic prostate cancer patients receiving androgen deprivation therapy (ADT).

The names of the study intervention involved in this study is:

• Supervised circuit training (aerobic and resistance exercise regimen)

Conditions

PROSTATE CANCER

Metastatic Prostate Cancer

Metastatic Prostate Carcinoma

Study ID

NCT06040125

Start date

Jan 1, 2024

Status verified date

Mar, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Aug 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ability to understand and the willingness to sign informed consent prior to any study-related procedures.
  • Diagnosed with metastatic prostate cancer.
  • Aged ≥18 years; due to the rarity of the disease in those <18 years, this age bracket will not be included.
  • Have been receiving androgen deprivation (either with or without androgen receptor targeted treatment) for at least one month and expect to remain on their treatment for at least 4 months.
  • Are pre-frail or frail as indicated by the FRAIL scale (a score of 1-2 = pre-frail; 3-5 = frail).
  • Have physician's clearance to participate in exercise.
  • Speak English.
  • Participate in less than 2 structured resistance exercise sessions per week over the last 4 months.
  • Participate in less than or equal to 60 minutes of moderate-to-vigorous aerobic exercise per week over the last month.
  • Willing to travel to Dana-Farber Cancer Institute for necessary data collection and exercise sessions.

Exclusion Criteria:

  • Receiving chemotherapy. This study is exclusively targeting androgen deprivation therapy-related effects.
  • Have unstable bone lesions. In general patients with severely symptomatic/unstable bone lesions due to bone metastases are at a higher risk of fractures.
  • Complete 2 or more structured resistance exercise sessions per week over the last 4 months and participate in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the last month. Excess additional exercise is a confounding factor in assessing the effect of the current exercise program.
  • Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities likely require supervised exercise for safety, and part of this study involves unsupervised exercise; therefore, for safety reasons, these persons are excluded.
  • Patients receiving treatment for other active malignancies (except basal cell carcinoma). This study is exclusively targeting androgen deprivation therapy-related effects.
  • Subjects who in the opinion of the investigators may not be able to comply with the safety monitoring requirements of the study.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Exercise Group

Participants will partake in a 16-week supervised exercise program.

experimental: Attention Control Group

Participants will continue with their normal daily activities.

Interventions

Supervised Circuit Training

16-week, multicomponent exercise intervention comprised of sessions supervised by certified exercise oncology trainer and home-based, self-directed aerobic exercises. Stationary bike and accelerometer (activity/heart rate monitor) will be provided.

Primary outcome measure

  • Change in Circulating Inflammation for Exercise Group [ Time Frame: Baseline (week 0) and Post-intervention (week 17) ]
  • Frailty [ Time Frame: Baseline (week 0) and Post-intervention (week 17) ]

Central Contacts and Locations

Central contacts

Christina Dieli-Conwright, MD

617-582-8321ChristinaM_Dieli-Conwright@dfci.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Christina Dieli-Conwright, PhD, MPH

617-582-8321ChristinaM_Dieli-Conwright@DFCI.HARVARD.EDU

Principal Investigator:

Christina Dieli-Conwright, PhD, MPH

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • Prostate Cancer
  • Metastatic Prostate Cancer
  • Metastatic Prostate Carcinoma

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 2026-03-11.