Exercise in Prostate Cancer

NCT06165302 | Recruiting

• 2 other identifiers: J23147IRB00410196
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn how exercise intervention affects circulating tumor cells (CTC) in men with advanced prostate cancer. The primary objective is to determine if an exercise intervention decreases CTCs in men with advanced prostate cancer. Participants will have baseline screening assessments, followed by 12 weeks of exercise intervention, and then follow-up assessments 12 weeks after the end of the exercise intervention.

Conditions

Prostate Cancer Metastatic; Prostate Cancer

Keywords

Exercise Intervention

Outcome Measures

Primary Outcomes (1)

• Number of participants with negative CTC count

  Number of participants with negative CTC count at 12 weeks compared to the baseline

  Baseline, 12 weeks

Secondary Outcomes (2)

• Number of participants with change in cell free DNA levels

  Baseline, 12 weeks

• Number of participants with change in Cell free RNA levels

  Baseline, 12 weeks

Study Arms (1)

Exercise Intervention

EXPERIMENTAL

Participants will be prescribed an exercise program after completing assessments at baseline. Participants will adhere to the prescribed exercise intervention for 12 weeks and log activity in a physical activity diary. Participants will return to clinic on Week 5 and Week 9 for assessments and adjustment to their exercise prescription as needed.

Behavioral: Exercise Intervention

Interventions

Exercise Intervention BEHAVIORAL

12 weeks of prescribed exercise intervention.

Exercise Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men with metastatic prostate adenocarcinoma
• Currently taking androgen deprivation therapy alone or with an oral androgen axis inhibitor (abiraterone, enzalutamide, darolutamide, or apalutamide are permitted) and have been on treatment for at least 3 months
• Elevated (PSA \> 1ng/mL) or rising PSA (any numerical increase based on at least 2 PSA readings at least 2 weeks apart)
• Any number of prior therapies (prior chemo, radium-223, etc.) is allowed
• CTC + according to standard clinical grade laboratory test by androgen receptor isoform splice variant 7 (AR-V7) testing at Hopkins.
• If a bone protective agent is to be started, it should be started at least 2 weeks prior to the onset of exercise intervention.
• Eastern Cooperative Oncology Group (ECOG) performance status \<=1
• Clearance by cardiologist if under the current care of a cardiologist (seen in the past 1 year)
• Age \<=80 years

You may not qualify if:

• Small cell carcinoma of the prostate
• Unable to participate or monitor exercise compliance due to conditions such as impaired cognition
• Moderate to severe bone pain that limits any activities of daily living, including use of narcotics for prostate cancer related pain
• Clinical progression requiring a change in systemic therapy or the addition of palliative radiation for symptom control
• Bone metastases in spine or long bones which, in the eye of the treating physician require referral to radiation oncology or surgery for management due to risk of fracture
• Significant cardiovascular disease or concurrent illness that would make exercise intervention for 12 weeks unsafe. If there is significant cardiovascular disease and the participant is under the care of a cardiologist (seen within the past 1 year), approval of the cardiologist to participate is required.
• Major surgery within the past 4 weeks

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• Physical Medicine & Rehabilitation Educ Research Foundation, Inc: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Cathy Marshall, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rana Sullivan, RN

CONTACT

410-614-6337; ProstateCancerClinicalTrials@live.johnshopkins.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2023
• First Posted: December 11, 2023
• Study Start: October 16, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): January 30, 2030
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)