Exercise in Prostate Cancer

Launched by SIDNEY KIMMEL COMPREHENSIVE CANCER CENTER AT JOHNS HOPKINS · Dec 1, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Exercise in Prostate Cancer," is designed to explore how exercise can impact the number of circulating tumor cells (CTCs) in men with advanced prostate cancer. The main goal is to see if regular exercise can help reduce these CTCs, which are cells that have spread from the original tumor and can indicate how advanced the cancer is. Men aged 65 to 80 who have metastatic prostate cancer and are currently undergoing specific hormone treatments may be eligible to participate. To qualify, participants need to have certain blood test results and be in good enough health to manage a 12-week exercise program.

If you join the trial, you will first undergo some health assessments, then participate in a structured exercise program for 12 weeks. After that, there will be follow-up assessments 12 weeks later to see how the exercise has affected your health and CTC levels. It’s important to know that this study is not yet recruiting, so you will need to wait until it officially starts. This trial aims to provide valuable insights into the benefits of exercise for men with advanced prostate cancer, potentially leading to new ways to manage the disease.

Gender

ALL

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