Exercise in Prostate Cancer

EPC Trial: Exercise in Prostate Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Prostate Cancer Metastatic
• Intervention / Treatment: Behavioral: Exercise Intervention

Detailed Description

This is a pilot single arm prospective study of personalized exercise training in men with metastatic castration resistant prostate cancer who are being treated with or without oral anti-androgens. The primary objective is to determine if combination of resistance and aerobic exercises lowers CTCs in men with mCRPC. Researchers will assess the rate of conversion from CTC positive to CTC negative in participants at the end of the 12 week exercise intervention. The study will enroll 20 participants onto the trial with the goal of at least 10 participants having blood drawn at both baseline and 12 weeks and completed at least 75% of the prescribed exercise sessions. Participants will undergo follow-up assessments at the end of the 12 week exercise intervention and the study team will monitor participant records for 365 days after the study completion for vital status.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rana Sullivan, RN; Phone Number: 410-614-6337; Email: ProstateCancerClinicalTrials@live.johnshopkins.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University
      • Contact: Niya Research Coordinator; Phone Number: 410-955-1017; Email: ncyrus1@jh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Men with metastatic prostate adenocarcinoma
2. 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
3. Elevated (PSA > 1ng/mL) or rising PSA (any numerical increase based on at least 2 PSA readings at least 2 weeks apart)
4. Any number of prior therapies (prior chemo, radium-223, etc.) is allowed
5. CTC + according to standard clinical grade laboratory test by androgen receptor isoform splice variant 7 (AR-V7) testing at Hopkins.
6. If a bone protective agent is to be started, it should be started at least 2 weeks prior to the onset of exercise intervention.
7. Eastern Cooperative Oncology Group (ECOG) performance status <=1
8. Clearance by cardiologist if under the current care of a cardiologist (seen in the past 1 year)
9. Age <=80 years

Exclusion Criteria:

1. Small cell carcinoma of the prostate
2. Unable to participate or monitor exercise compliance due to conditions such as impaired cognition
3. Moderate to severe bone pain that limits any activities of daily living, including use of narcotics for prostate cancer related pain
4. Clinical progression requiring a change in systemic therapy or the addition of palliative radiation for symptom control
5. 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
6. 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.
7. Major surgery within the past 4 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise Intervention; 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; 12 weeks of prescribed exercise intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with change in cell free DNA levels	Number of participants with change in cell free DNA levels from baseline to 12 weeks	Baseline, 12 weeks
Number of participants with change in Cell free RNA levels	Number of participants with change in cell free RNA levels from baseline to 12 weeks	Baseline, 12 weeks

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Physical Medicine & Rehabilitation Educ Research Foundation, Inc
• Investigators: Principal Investigator: Cathy Marshall, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2025
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): January 30, 2030

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 15, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Exercise Intervention
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: J23147; IRB00410196 (Other Identifier: JHM IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No