Clinical trial · Interventional
PROState Cancer Patients Initiating Hormone Therapy: Effect of Exercise on CARDIOvascular Health (PROSCARDIO)
Effects of Exercise in Prostate Cancer Patients Initiating Androgen Deprivation Therapy: A Randomised Controlled Trial
NCT03776045CI-TRIAL-00036141PROSCARDIOcompletedN/AClinicalTrials.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)
This study evaluates whether exercise can reduce treatment-related adverse effects in prostate cancer patients initiating androgen deprivation therapy. Half of recruited participants completed a 3-month exercise intervention, while the other half did not perform any supervised exercise. It was anticipated that exercise would have a positive effect on body composition, cardiorespiratory fitness and quality of life.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard care plus exercise | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard care
- description
- This group did not receive any supervised exercise or were not given any specific exercise recommendations during the trial period. However, patients in this group were offered the exercise intervention after completing the study.
- type
- EXPERIMENTAL
- label
- Standard care plus exercise
- description
- This group received standard care in addition to a 3-month exercise intervention upon initiating androgen deprivation therapy.
- interventionNames
- Other: Standard care plus exercise
Primary outcomes (1)
- measure
- Whole body fat mass (kg)
- timeFrame
- Adjusted mean difference between groups at 3-month endpoint
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Male * Aged 50 to 80 years * Histologically confirmed stage I-IV prostate cancer * Scheduled for treatment with a luteinizing hormone-releasing hormone (LHRH) agonist either alone or combined with radiotherapy * Anticipated to remain on androgen deprivation therapy (ADT) for at least the next 6 months * Willing and able to give written informed consent. * Understand written and verbal instructions in English * World Health Organisation (WHO) performance status 0 to 1 Exclusion Criteria: * Previously treated with ADT * Diagnosed or suspected metastatic bone disease * Absolute contraindications to exercise testing and training as defined by the American College of Sports Medicine (ACSM, 2010) * Prior myocardial infarction or heart failure * Chronic obstructive pulmonary disease (COPD) * Poorly controlled hypertension (≥ 200/110 mmHg) * Uncontrolled supraventricular tachycardia (≥ 100 bpm) * Pre-existing severe musculoskeletal, neurological or psychiatric condition that may affect their ability to complete the testing battery or exercise training, as determined by the patient's physician * Involvement in any other clinical trial or exercise trial
References
Publications (2)
- BACKGROUNDGalvao DA, Taaffe DR, Spry N, Joseph D, Newton RU. Acute versus chronic exposure to androgen suppression for prostate cancer: impact on the exercise response. J Urol. 2011 Oct;186(4):1291-7. doi: 10.1016/j.juro.2011.05.055. Epub 2011 Aug 17. PMID 21849187
- BACKGROUNDSavastano S, Belfiore A, Di Somma C, Mauriello C, Rossi A, Pizza G, De Rosa A, Prestieri G, Angrisani L, Colao A. Validity of bioelectrical impedance analysis to estimate body composition changes after bariatric surgery in premenopausal morbidly women. Obes Surg. 2010 Mar;20(3):332-9. doi: 10.1007/s11695-009-0006-5. Epub 2009 Oct 28. PMID 19862582