Recruiting

Exercise Intervention

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT06165302

Conditions

Prostate Cancer Metastatic

Prostate Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise Intervention

Study Details

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

Study ID

NCT06165302

Start date

Oct 16, 2025

Status verified date

Oct, 2025

Completion date

Jan 30, 2030

Anticipated

Primary completion date

Mar 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

Exercise Intervention

12 weeks of prescribed exercise intervention.

Primary outcome measure

  • Number of participants with negative CTC count [ Time Frame: Baseline, 12 weeks ]

Central Contacts and Locations

Locations

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Niya Research Coordinator

410-955-1017ncyrus1@jh.edu

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Keywords

  • Exercise Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2025-10-20.