Clinical trial · Interventional
Exercise Prescription Dose for Castration Resistance Prostate Cancer Patients
Exercise Prescription Dose for Castration Resistance Prostate Cancer Patients: a Phase I Prescription Dose Escalation 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)
Recent drug improvement (e.g. abiraterone or enzalutamide) for castration resistant prostate cancer (CRPC) patients has improved survival. As treatment strategies improve and patients live longer, patients must cope with their treatment-induced adverse effects. Improving levels of physical activity (PA) and less amounts of sitting time (e.g. sedentary behavior, SB) could have a positive impact on patient's health, non-cancer mortality, and quality of life and potentially improve survival. The role of PA has not yet been examined in CRPC patients, which is a clear unmet need. No specific PA guidelines exist for CRPC patients, but specific guidelines are warranted because of advanced disease stage, reduced performance score and comorbidity. It is to be expected that the PA level of CRPC patients is lower compared to non-CRPC patients receiving androgen deprivation therapy (ADT). This study aims to determine the optimal starting physical therapy prescription in CRPC patients receiving second line hormone treatment.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
| Exercise | — | UNRESOLVED | — |
| Physical Activity | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm phase I trial with 3 exercise dose-escalation arms
- description
- exercise dose-escalation: aerobic, resistance and flexibility training
- interventionNames
- Behavioral: Exercise
Primary outcomes (3)
- measure
- Maximum tolerated dose based on tolerance
- timeFrame
- change before and after 1 exercise session (at one day)
- description
- Maximum tolerated dose will be assessed by borg scale of perceived exertion.
- measure
- Maximum tolerated dose based on safety
- timeFrame
- change before and after 1 exercise session (at one day)
- description
- Maximum tolerated dose will be assessed by CTCAE
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * CRPC patients with second-line hormone treatment * Able to walk 400 meters without help from another person * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (those conditions should be discussed with the patient before registration in the trial) * ≥4 weeks since any major surgery and fully recovered before patient registration * Written informed consent must be given according to International conference on harmonization Good Clinical Practice and national regulation. Exclusion Criteria: * Musculoskeletal, cardiovascular or neurological comorbidity that prevent the patient to participate in an exercise program * Painful bone metastases (VAS) at the time of inclusion * Unstable bone metastases (SINS classification) at time of inclusion
References
Publications (0)
Data not yet available