| NCT ID | NCT06165302 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Condition | Prostate Cancer Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-10-16 |
| Primary Completion | 2029-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-10-16 with a primary completion date of 2029-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Cathy Marshall, MD
PRINCIPAL INVESTIGATOR
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Frequently Asked Questions
Who can join the NCT06165302 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Prostate Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06165302 currently recruiting?
Yes, NCT06165302 is actively recruiting participants. Contact the research team at ProstateCancerClinicalTrials@live.johnshopkins.edu for enrollment information.
Where is the NCT06165302 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT06165302 clinical trial?
NCT06165302 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The principal investigator is Cathy Marshall, MD at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The trial plans to enroll 20 participants.
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