Health TrialsbyHealthPanel

Exercise in Prostate Cancer

ConditionsProstate Cancer MetastaticProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 that limits any activities of daily living, including use of narcotics for prostate cancer related pain

Clinical progression requiring a change in systemic therapy or the addition of palliative radiation for symptom control

Trial design

Design model

Single group

Treatments tested in this trial

  • Exercise Intervention

    Behavioral

    12 weeks of prescribed exercise intervention.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Exercise InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with negative CTC count

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

Time frame
Baseline, 12 weeks

Secondary outcomes

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

Time frame
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

Time frame
Baseline, 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead sponsor

Physical Medicine & Rehabilitation Educ Research Foundation, Inc

Collaborator

Source ClinicalTrials.gov
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