Status:
RECRUITING
Exercise in Prostate Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Physical Medicine & Rehabilitation Educ Research Foundation, Inc
Conditions:
Prostate Cancer Metastatic
Prostate Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
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 i...
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. Th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2030
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06165302
Start Date
October 16 2025
End Date
January 30 2030
Last Update
October 17 2025
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287