Recruiting

Exercise

Sponsor:

Fred Hutchinson Cancer Center

Code:

NCT05918263

Conditions

Prostate Cancer

Prostatic Neoplasms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High-Intensity Interval Training Exercise Program

High-Intensity Interval Training Exercise Program

Study Details

Brief summary:

The purpose of this study is to determine whether a 12-week, home-based, virtually supervised exercise program will slow cancer progression of prostate cancer among men with prostate cancer at high-risk of progression undergoing active surveillance.

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

Aerobic high-intensity interval training (HIIT) (training exercise intervention)

Conditions

Prostate Cancer

Prostatic Neoplasms

Study ID

NCT05918263

Start date

Jan 1, 2024

Status verified date

Jul, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 years.
  • Histologically diagnosed with localized prostate cancer.
  • Initiating or undergoing active surveillance.
  • Having a higher risk of progression, defined as meeting one or more of the following: (1) favorable- intermediate risk prostate tumor at diagnosis, (2) obesity (body mass index ≥ 30), and/or (3) self- identified as Black or African American.
  • No plans for invasive treatment for their prostate cancer in the 12 weeks following the time of enrollment.
  • Ability to understand and willingness to provide informed consent.

Exclusion Criteria:

  • Received any invasive curative-intent treatment for prostate cancer, including surgery, chemotherapy, radiation therapy, and hormonal therapy.
  • Patients with metastasis and/or other active malignancies (except basal cell carcinoma) and/or receiving treatment for those malignancies.
  • Participating in any (>0 min/week) high-intensity exercise at the time of recruitment.
  • Having chronic medical conditions that are clinically unstable or uncontrolled with medications, deemed high-risk for exercise. These include but are not limited to unstable cardiac diseases, uncontrolled diabetes, and bone metastases with imminent risk of fracture.
  • Having a high risk for noncompliance with study procedures. This will be determined by the study team based on the history of missed oncology appointments (i.e., ≥3 no-shows in 6 months) and poor responsiveness during recruitment (i.e., ≥3 unreturned contacts).
  • Patients who are non-English speaking and unable to complete the participant surveys.

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group A: HIIT Exercise Program

Participants will be allocated in a 1:1 ratio, using a permuted blocked design with varying block size. Study procedures will be conducted as follows:

  • Testing visits at Week 1 and 14 for physical exams, physical fitness and function assessments, survey questionnaires, and cardiopulmonary fitness assessment.
  • Virtual, aerobic training sessions three times weekly with trained oncology exercise specialist.

experimental: Group B: Waitlist Control

Participants will be allocated in a 1:1 ratio, using a permuted blocked design with varying block size. Study procedures will be conducted as follows:

  • Testing visits at Week 1 and 14 for physical exams, physical fitness and function assessments, and survey questionnaires.
  • Upon completion of post-intervention assessments, participants will have the option to take part in the 12-week HIIT exercise program.

Interventions

High-Intensity Interval Training Exercise Program

Home-based, virtually supervised, aerobic exercise program of 36 sessions accessible via internet-enabled tablet (provided to participant if needed). Participants will be supplied with stationary bike, heart rate monitor, and blood pressure monitor.

High-Intensity Interval Training Exercise Program

(Optionally) Home-based, virtually supervised, aerobic exercise program of 36 sessions accessible via internet-enabled tablet (provided to participant if needed). Participants will be supplied with stationary bike, heart rate monitor, and blood pressure monitor.

Primary outcome measure

  • Prostate-Specific Antigen (PSA) Level [ Time Frame: Baseline (Week 1) and post-intervention (Week 14) ]

Central Contacts and Locations

Central contacts

Dong-Woo Kang, PhD

206-667-5188dkang@fredhutch.org

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Dong-Woo Kang, PhD

206-667-5188dkang@fredhutch.org

Principal Investigator:

Dong-Woo Kang, PhD

More Information

Sponsor

Fred Hutchinson Cancer Center

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • Prostate Cancer
  • Prostatic Neoplasms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fred Hutchinson Cancer Center on 2026-07-15.