Clinical trial · Interventional
Exercise in Prostate Cancer
EPC Trial: Exercise in Prostate Cancer
NCT06165302CI-TRIAL-00096636recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Exercise Intervention
- description
- 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.
- interventionNames
- Behavioral: Exercise Intervention
Primary outcomes (1)
- measure
- Number of participants with negative CTC count
- timeFrame
- Baseline, 12 weeks
- description
- Number of participants with negative CTC count at 12 weeks compared to the baseline
Secondary outcomes (2)
- measure
- Number of participants with change in cell free DNA levels
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.