urologische aandoeningen prostate cancer prostate carcinoma
Conditions
Interventions
Prostate cancer
Survival
Exercise
A 1 year supervised aerobic and resistance exercise program. After the
completion of the supervised exercise program, the respondent will complete a 1
year self-managed exercise program. Over the co
Sponsors
The Movember Foundation
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Patients must be mCRPC. This is defined as adenocarcinoma of the prostate with systemic metastatic disease despite castrate levels of testosterone (20% increase in the sum of diameters of measurable lesions from the time of maximal regression or appearance of one or more new lesions. * Bone Scan Progression: Appearance of one or more new lesions on bone scan attributable to prostate cancer. * PSA Progression: PSA >=2 ng/ml that has risen serially on at least two occasions, each at least one week apart (PSA1 =4 weeks since last major surgery and fully recovered. * No known contraindications to high intensity exercise, including, but not limited to: brain metastases; current congestive heart failure (New York Heart Association Class II, III or IV); serious or non-healing wound, ulcer, or bone fracture; spinal cord compromise or instrumentation due to metastatic disease; peripheral neuropathy >=grade 3. No serious cardiovascular events within 12 months including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI). Patients with a history of hypertension must be well-controlled (=18 years * Required Baseline Laboratory Values: ANC >= 1500/uL; Platelet count >= 100,000/uL; Creatinine <= 1.5 x upper limits of normal; Bilirubin <= 1.5 x upper limits of normal; AST <= 1.5 x upper limits of normal; Serum testosterone <= 50 ng/dL * ECOG performance status 0-1 * Medical clearance by treating physician to undergo a symptom-limited cardiopulmonary exercise test and vigorous aerobic and resistance exercise training, and able to complete an acceptable cardiopulmonary exercise test. * Exercise Coordin
Exclusion criteria
Exclusion criteria: * Previous radiographic or clinical progression (PSA progression is permitted) while on treatment with abiraterone, enzalutamide, apalutamide, or a combination. * Previously identified small cell neuroendocrine tumours or pure small cell carcinoma of the prostate, based on a prior biopsy of the prostate. * Brain metastases (brain imaging is not required) * Previous and/or concurrent treatment with other anti-cancer treatments is permitted. Patients are allowed to be treated with chemotherapy during the duration of the trial. Patients who have received chemotherapy as part of initial androgen deprivation therapy for metastatic castration sensitive disease are eligible. * Currently receiving experimental treatment with non-approved drugs at the time of enrolment. Patients must undergo a 28-day washout between last dose and screening CPET. * Poorly controlled hypertension. During screening >=2/3 of readings must be =grade 3. * Men participating in vigorous aerobic exercise for more than 60 minutes per week or structured resistance exercise two or more days per week (seek ECC approval before exclusion). * Experiences shortness of breath, chest discomfort, or palpitations when performing activities of daily living (patient with these symptoms can participate in the study with cardiologist clearance) * Ongoing restriction of physical activity with physician documentation * Has chest pain brought on by physical activity (patient can participate in the study with cardiologist clearance) * Has developed chest pain in the past month (patient can participate in the study with cardiologist clearance) * Moderate-to-severe bone pain (i.e., National Cancer Institute*s Common Terminology Criteria for Adverse Events grade 2-3 bone pain). * Men who do not complete the baseline lifestyle and quality-of-life questionnaires and 3-days of diet diaries or country-specific FFQ will not be eligible
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints Progression-free survival, symptomatic skeletal-related events, pain, opiate use, cancer-related fatigue, metabolic biomarkers, physical function, quality-of-life (QOL) and QOL-adjusted survival | — |
Countries
The Netherlands
Outcome results
None listed