A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorCity of Hope Medical Center
About this trial
To determine the effects of exercise therapy on molecular, radiologic, and pathologic nimbosus hallmarks versus usual care control in men on Active Surveillance for localized prostate cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18
Men with histologically confirmed localized prostate cancer undergoing active surveillance.
Inactive, defined as not meeting the national exercise guidelines for cancer patients (<150 minutes/week of moderate or vigorous exercise)43 as assessed by remote activity and heart rate tracking for a 7-day period prior to study entry (general physical activity screening assessment via smart watch).
Screening clearance by an MSK Exercise Physiologist (i.e., review of ECG)
Disqualifiers
Enrollment in any other program that may alter the impact of exercise on tumor outcomes (e.g., weight loss program)
Any neoadjuvant anticancer treatment of any kind for prostate cancer in the last 5 years
Any history of systemic anticancer therapy in the last 15 years
Distant metastatic malignancy of any kind
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise Therapy
BehavioralThe intervention will consist of exercise therapy, individualized, walking delivered following a non-linear (i.e., exercise dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule, up to 5 individual treatment sessions/week to achieve a cumulative total duration of 225 to 300 mins/wk until the participant's next standard of care prostate biopsy (about 6-12 months).
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Participants Assigned to Exercise TherapyExperimental treatment 1 intervention
Group B: Participants Assigned to Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in molecular, radiologic, and pathologic nimbosus hallmarks from baseline to follow-up
The phenomenon of multiple independent prognostic features that moderately correlate with one another has been termed Nimbosus, "a gathering of storm clouds". The more Nimbosus hallmarks present in a tumor, the more aggressive it is likely to be, and the greater the chance that it will escape the prostate leading to nodal and distal metastatic spread. Nimbosus hallmarks provides a targetable set of biomarkers to test in a RCT of exercise therapy in localized prostate cancer. Molecular end points will be evaluated on FFPE tumor samples obtained from a total of two ultrasound-guided transrectal prostate biopsies performed at pretreatment (diagnostic biopsy) and post-intervention around month 6-12 (confirmatory biopsy), as per standard procedures.
Time frame
6-12 monthsSponsors and contacts
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Source ClinicalTrials.gov