Clinical trial · Interventional
A Study on the Effects of Exercise Therapy on Signs of Prostate Cancer
Phase 2 Trial of Exercise Therapy on Markers of Progression in Localized Prostate Cancer
NCT05751434CI-TRIAL-00119903recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localized Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Participants Assigned to Exercise Therapy
- description
- Participants with histologically confirmed localized prostate cancer undergoing active surveillance
- interventionNames
- Behavioral: Exercise Therapy
- type
- NO_INTERVENTION
- label
- Participants Assigned to Usual Care
- description
- Participants with histologically confirmed localized prostate cancer undergoing active surveillance
Primary outcomes (1)
- measure
- Change in molecular, radiologic, and pathologic nimbosus hallmarks from baseline to follow-up
- timeFrame
- 6-12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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) * BMI \<40 kg/m\^2 * Cleared for exercise participation as per pre-screening clearance via the Physical Activity Readiness Questionnaire (PAR-Q+) (Appendix B) Exclusion Criteria: * 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 * Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation
References
Publications (0)
Data not yet available
No reference posted for this study.