NCT05918263

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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable prostate-cancer

Timeline
8mo left

Started Jan 2024

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Jan 2024Mar 2027

First Submitted

Initial submission to the registry

June 14, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

3.2 years

First QC Date

June 14, 2023

Last Update Submit

July 13, 2026

Conditions

Prostate CancerProstatic Neoplasms

Keywords

Prostate CancerProstatic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Prostate-Specific Antigen (PSA) Level

    The primary outcome is the between-group difference in prostate-specific antigen (PSA) levels post-intervention. Analysis of covariance will be used to detect the difference adjusting for baseline values of the outcome and other covariates.

    Baseline (Week 1) and post-intervention (Week 14)

Secondary Outcomes (13)

  • Prostate-Specific Antigen (PSA) Velocity

    Baseline (Week 1) and post-intervention (Week 14)

  • Prostate-Specific Antigen (PSA) Doubling Time

    Baseline (Week 1) and post-intervention (Week 14)

  • Proliferation of LNCaP Prostate Cancer Cell Line

    Baseline (Week 1) and post-intervention (Week 14)

  • Cardiorespiratory Fitness

    Baseline (Week 1) and post-intervention (Week 14)

  • Muscular Strength

    Baseline (Week 1) and post-intervention (Week 14)

  • +8 more secondary outcomes

Study Arms (2)

Group A: HIIT Exercise Program

EXPERIMENTAL

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.

Behavioral: High-Intensity Interval Training Exercise Program

Group B: Waitlist Control

EXPERIMENTAL

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.

Behavioral: High-Intensity Interval Training Exercise Program

Interventions

High-Intensity Interval Training Exercise ProgramBEHAVIORAL

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.

Group A: HIIT Exercise Program

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

COMPLETED

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

COMPLETED

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

COMPLETED

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Dong-Woo Kang, PhD

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Woo Kang, PhD

CONTACT

206-667-5188dkang@fredhutch.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Principal investigator blinded to block size
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 26, 2023

Study Start

January 1, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(4)