Personalized exercise program for men with metastatic prostate cancer
EPC Trial: Exercise in Prostate Cancer
This study will try a 12-week personalized aerobic and resistance exercise program to see if it lowers circulating tumor cells in men with advanced prostate cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06165302 on ClinicalTrials.gov |
What this trial studies
This pilot, single-arm study will enroll about 20 men with metastatic castration-resistant prostate cancer who are CTC-positive. Participants will follow a personalized combination of resistance and aerobic exercise for 12 weeks with baseline, end-of-intervention, and 12-week post-intervention assessments. The primary outcome is the rate of conversion from CTC-positive to CTC-negative at the end of the exercise period, with a target analysis set of participants completing at least 75% of prescribed sessions. The study team will also monitor participants' vital status for 365 days after study completion.
Who should consider this trial
Good fit: Men with metastatic castration-resistant prostate adenocarcinoma who are CTC-positive by AR-V7 testing, age ≤80, ECOG ≤1, on androgen-deprivation therapy (with or without an oral androgen-axis inhibitor) for at least 3 months, and able to perform supervised exercise are ideal candidates.
Not a fit: Patients with small cell prostate carcinoma, ECOG >1, significant cardiac contraindications to exercise, inability to perform the required exercise sessions, or who are CTC-negative are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the program could provide a non-drug way to reduce circulating tumor cells and possibly slow disease progression.
How similar studies have performed: Prior exercise trials in prostate cancer have improved fitness, strength, and quality of life, but using exercise specifically to reduce circulating tumor cells is novel and unproven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Cathy Marshall, MD — Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Study coordinator: Rana Sullivan, RN
- Email: ProstateCancerClinicalTrials@live.johnshopkins.edu
- Phone: 410-614-6337
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.