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Exercise in Prostate Cancer

EPC Trial: Exercise in Prostate Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 365 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will undergo follow-up assessments at the end of the 12 week exercise intervention and the study team will monitor participant records for 365 days after the study completion for vital status."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (1)

MD