Clinical trial · Interventional
Behavioral Exercise Training to Reduce Cardiovascular Disease Risk
Behavioral Exercise Training to Reduce Cardiovascular Disease Risk in Men Undergoing Androgen Deprivation Therapy (EXTRA-PC)
NCT06237179CI-TRIAL-00104374EXTRA-PCrecruitingPhase 1 / Phase 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 test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak \& 6-minute walk distance \[6MWD\]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 weeks.
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 |
| Supportive Care | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise Training Intervention | Behavioral | — | UNRESOLVED |
| Healthy Living Education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Exercise Training Intervention
- description
- The exercise program (ET) is tailored to each participant depending on his initial functional capacity, cardiorespiratory fitness and strength, to achieve ≥150 moderate to vigorous physical activity
- interventionNames
- Behavioral: Exercise Training Intervention
- type
- ACTIVE_COMPARATOR
- label
- Healthy Living Education Control
- description
- Educational modules delivered remotely (or manual and telephone call) in a group-based setting to approximately match contact frequency and structure with the ET arm.
- interventionNames
- Behavioral: Healthy Living Education
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Be diagnosed with stage II/III/IV prostate cancer * Be currently undergoing treatment with ADT (intermittent or prolonged) * Have completed local curative-intent treatment, including prostatectomy or definitive radiation; * Be \>40 years of age up to 85; * Be willing to sign an informed consent with HIPAA authorization form; * Not have any hearing or sight impairments that result in the inability to use the telephone or hear normal conversation; * Must be able to join an intervention group by personal computer, smartphone or telephone call and should agree to recording of an interview; * Be without any serious medical condition that precludes safe participation in an exercise program; * Speak English Exclusion Criteria: * Be unable to undergo MRI (i.e., ferromagnetic materials in body, inability to lie flat, claustrophobia); * Have contraindications to exercise testing; * Have pre-existing overt cardiovascular disease/heart failure; * Active illness/infection; * Hemoglobin \< 7.0 grams/dL * Platelet count \< 10 x 109/L
References
Publications (0)
Data not yet available
No reference posted for this study.