Clinical trial · Interventional
A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer
A COMbined progRamme of Exercise and Dietary ADvice in mEn With Castrate Resistant Prostate Cancer - COMRADE Trial
- 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)
The proposed study will assess the feasibility of an exercise and dietary intervention in men with castrate resistant prostate cancer with secondary outcomes assessing improvements in physical functioning, fatigue, quality of life, and body composition.The study will have 2 arms, with one set of participants randomized to resistance exercise training intervention plus dietary advice and the other arm will be standard of care plus exercise advice.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostatic Neoplasms, Castration-Resistant | Prostate Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Intervention | Other | — | UNRESOLVED |
| standard of care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise Intervention arm
- description
- exercise training intervention to include: * DEXA scan will collect data on via a full body scan to determine post-cranial appendicular whole body LM, whole body fat free mass (FFM) and whole body FM. * Muscle Strength assessment * Physical function assessment * Questionnaires and diet diaries
- interventionNames
- Other: Exercise Intervention
- type
- ACTIVE_COMPARATOR
- label
- standard of care arm
- description
- * standard treatment * exercise advice * Questionnaires
- interventionNames
- Other: standard of care
Primary outcomes (1)
- measure
- Number of participants recruited who complete the intervention
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: * Men with Castrate resistant prostate cancer * Men with histologically confirmed PCa on long-term ADT with either * PSA\>2ng/ml above nadir or PSA level that has risen serially on at least two occasions (each at least 4 weeks apart) in the presence of castrate levels of testosterone or; * Evidence of symptomatic disease progression whilst undergoing first line androgen deprivation therapy (ADT) in the presence of castrate levels of testosterone or; * Radiographic disease progression whilst undergoing first line ADT in the presence of castrate levels of testosterone Exclusion Criteria: * • Participation in other trials which might bias the evaluation of the primary objectives of the present study. * Current participation in regular physical activity (defined as purposeful physical activity of a moderate intensity for 90 minutes per week for at least six months). * Unstable angina, uncontrolled hypertension, recent myocardial infarction, pacemakers. * Uncontrolled painful or unstable bony metastatic lesions. * Within two months of invasive surgical treatment (transurethral surgery allowed). * Any physical, neurological or psychiatric impairment or disease or other condition that would limit the ability to understand and complete the study assessments and complete the required questionnaires, recall and record of dietary information would be excluded.
References
Publications (0)
Data not yet available