Personalized exercise program for men with metastatic prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 + at screening
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. Determined to be physically ready for exercise by PM\&R physician

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, including pain requiring the use of narcotics for prostate cancer related pain, or pain that limits any activities of daily living
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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Epidemiology, diagnosis, and treatment patterns of prostate cancer in Algeria

  This project collects medical and treatment information to see how prostate cancer is diagnosed and managed in Algerian men with confirmed disease.

  Recruiting at 21 sites Société Algérienne de Formation et Recherche en Oncologie · Adrar, Algeria and 23 other locations · NCT07484971

• Treatment for advanced prostate cancer using Pluvicto

  This study is testing if a new treatment called Pluvicto can help men with advanced prostate cancer that has spread to their bones feel better and improve their quality of life.

  Recruiting Phase 2 Excel Diagnostics and Nuclear Oncology Center · Houston, Texas · NCT06972628

• 7-day water-only fasting for metastatic prostate cancer

  This study will test whether a 7-day water-only fast (with a ketogenic very low-calorie option) is safe and doable for people with metastatic prostate cancer.

  Recruiting Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland · NCT06826924

• Treatment for HER2-Positive Metastatic Castration-Resistant Prostate Cancer

  This study is testing a new drug called Enhertu to see if it can help people with a specific type of advanced prostate cancer who haven't had success with other treatments.

  Recruiting Phase 2 Washington D.C. Veterans Affairs Medical Center · Washington D.C., District of Columbia · NCT06610825

• Using a new type of PET scanner for imaging prostate cancer and related conditions

  This study is testing a new type of PET scanner to see if it can better detect early signs of prostate cancer and related conditions in patients.

  Recruiting Jagiellonian University · Krakow · NCT06242119

• Evaluating frailty and side effects in older men with metastatic prostate cancer receiving hormone therapy

  This study is trying to find out what makes older men with advanced prostate cancer feel weaker and have side effects while they are on hormone therapy.

  Recruiting University of Chicago · Chicago, Illinois · NCT06215508

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.