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Prostate Cancer MetastaticNCT06165302

Exercise in Prostate Cancer

A study testing Exercise Intervention in people with Prostate Cancer Metastatic and Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer Metastatic, Prostate Cancer
What is being tested?
Exercise Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
16 Oct 2025to 30 Jan 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men with metastatic prostate adenocarcinoma
  • 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
  • Elevated (PSA >= 1ng/mL) or rising PSA (any numerical increase based on at least 2 PSA readings at least 2 weeks apart)
  • Any number of prior therapies (prior chemo, radium-223, etc.) is allowed
  • CTC + at screening
  • If a bone protective agent is to be started, it should be started at least 2 weeks prior to the onset of exercise intervention.
Show all 9Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status <=1
  • Clearance by cardiologist if under the current care of a cardiologist (seen in the past 1 year)
  • Determined to be physically ready for exercise by PM\&R physician

Who cannot join

  • Small cell carcinoma of the prostate
  • Unable to participate or monitor exercise compliance due to conditions such as impaired cognition
  • 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
  • Clinical progression requiring a change in systemic therapy or the addition of palliative radiation for symptom control
  • 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
  • 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.
  • Major surgery within the past 4 weeks

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rana Sullivan, RN contact

410-614-6337

ProstateCancerClinicalTrials@live.johnshopkins.edu

United States1 site, 1 recruiting

  • Johns Hopkins University

    Baltimore, Maryland, 21287

    Rana Sullivan, RN, 410-614-6337, Tomalra@jhmi.edu

    Recruiting

Other trials in United States

About this study

Official title: EPC Trial: Exercise in Prostate Cancer

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.

Read the detailed description

This is a pilot single arm prospective study of personalized exercise training in men with metastatic castration resistant prostate cancer who are being treated with or without oral anti-androgens. The primary objective is to determine if combination of resistance and aerobic exercises lowers CTCs in men with mCRPC. Researchers will assess the rate of conversion from CTC positive to CTC negative in participants at the end of the 12 week exercise intervention. The study will enroll 20 participants onto the trial with the goal of at least 10 participants having blood drawn at both baseline and 12 weeks and completed at least 75% of the prescribed exercise sessions. 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.

Being tested
Exercise Intervention
Keywords
Exercise Intervention
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise InterventionBehavioural

    12 weeks of prescribed exercise intervention.

Study groups in NCT06165302
Study groupRoleWhat they receive
Exercise InterventionExperimentalParticipants 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.
Receives: Behavioral: Exercise Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with negative CTC count

    Number of participants with negative CTC count at 12 weeks compared to the baseline

    Measured: Baseline, 12 weeks

Secondary outcomes (2)

  1. Number of participants with change in cell free DNA levels

    Number of participants with change in cell free DNA levels from baseline to 12 weeks

    Measured: Baseline, 12 weeks

  2. Number of participants with change in Cell free RNA levels

    Number of participants with change in cell free RNA levels from baseline to 12 weeks

    Measured: Baseline, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2023
  2. Study start16 Oct 2025
  3. Primary completion1 Mar 2029 (estimated)
  4. Study completion30 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06165302
Sponsor's protocol ID
J23147
Other IDs
IRB00410196
Status last verified
Oct 2026
First submitted
1 Dec 2023
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Intervention in people with Prostate Cancer Metastatic and Prostate Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rana Sullivan, RN (410-614-6337, ProstateCancerClinicalTrials@live.johnshopkins.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with negative CTC count (time frame: Baseline, 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06165302.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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