Clinical trial · Interventional
Exercise Intervention for Pts With Metastatic Castration-Resistant Prostate Cancer Receiving Abiraterone or Enzalutamide
Randomized, Controlled Study of an Exercise Intervention Program for Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Either Abiraterone or Enzalutamide
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): We were not able to accrue any participants.
Summary
Brief summary (as posted)
This randomized pilot study will be conducted in men with metastatic castration resistant prostate cancer (mCRPC) within 3 months of initiating abiraterone or enzalutamide. The purpose of this pilot study is to evaluate the effects of a 12 week exercise intervention in mCRPC patients who have recently started on additional androgen suppression therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration Resistant Prostate Cancer (mCRPC) | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise Intervention Arm
- description
- The exercise intervention will consist of a combination of aerobic (cardiovascular exercise) and strength training (emphasis of the intervention) 3 times per week for 12 weeks with each session lasting \~1.5 hours.
- interventionNames
- Behavioral: Exercise
- type
- NO_INTERVENTION
- label
- Non-Exercise Control Arm
- description
- Participants in the Non-Exercise Control Arm will not exercise for 12 weeks.
Primary outcomes (1)
- measure
- Change in lean mass between mCPRC patients undergoing a 12-week exercise intervention (intervention group) and mCPRC patients who do not undergo the exercise intervention (control group)
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥18 years of age 2. Metastatic disease that has progressed despite castrate levels of testosterone (surgically or medically castrated, with testosterone levels of \< 50 ng/dL) 3. No prior chemotherapy 4. Initiated therapy with either abiraterone plus a glucocorticoid or enzalutamide within the 3 months prior to randomization 5. Ability to engage safely in moderate exercise as determined by their treating physician 6. Not previously engaged in regular exercise training (\>1-2 d/wk for \> 30 min/d) in the past 6 months 7. Be able to speak and read English Exclusion Criteria: 1. Any condition that causes severe pain with exertion 2. History of bone fractures 3. Active cardiovascular disease including any of the following: * New York Heart Association (NYHA) Grade II or greater congestive heart failure * History of myocardial infarction or unstable angina within 6 months prior to Day 1 * History of stroke or transient ischemic attack within 6 months prior to Day 1 4. Acute or chronic respiratory disease 5. Acute or chronic bone/joint/muscular abnormalities compromising their ability to exercise 6. Neurological conditions that affect balance and, or muscle strength 7. Dementia, altered mental status or any psychiatric condition prohibiting the understanding or rendering of informed consent
References
Publications (0)
Data not yet available