INTense Exercise foR surVivAL Among Men With Metastatic Castrate-Resistant Prostate Cancer
a study on Prostate Cancer
- for males ages 18 years and up
- Healthy Volunteers
- healthy people welcome
- at San Francisco, California and other locations
- study started
A Study to determine if high intensity aerobic and resistance training plus psychosocial support increases overall survival compared to psychosocial support alone in patients with metastatic castrate-resistant prostate cancer.
Prostate Cancer Metastatic Castrate-Resistant
You can join if…
Open to males ages 18 years and up
- Patients must have histologically documented adenocarcinoma of the prostate with progressive systemic (clinically metastatic disease documented on bone, CT, or magnetic resonance imaging (MRI) scan) disease despite castrate levels of testosterone(<50 ng/dL) due to orchiectomy or luteinizing hormone-releasing hormone (LHRH)agonist. Castrate levels of testosterone must be maintained.
- Patients must be either:
- Currently on abiraterone and/or enzalutamide and not progressing; OR
- Pre-abiraterone and pre-enzalutamide with demonstrated evidence of progressive disease. Defined as at least one of the following:
- Measurable Disease Progression:>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.
- Prostate- specific antigen (PSA) Progression: An elevated PSA ≥2 ng/ml that has risen serially on at least two occasions, each at least one week apart (PSA1 < PSA2 < PSA3).If the 3rd PSA value is less than the 2nd PSA value, than an additional test for rising PSA is required to document progression. (For the purposes of the nomogram calculator, the last PSA value recorded prior to initiation of the intervention will be considered the baseline PSA)
- On Androgen Deprivation Therapy (ADT) with a Gonadotropin-releasing hormone (GnRH)agonist/antagonist or prior bilateral orchiectomy. All patients will be required to be on ADT throughout the study;
- ≥4 weeks since any major surgery and fully recovered.
- Halabi Nomogram score <1951
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patients must be able to travel to one of the study-designated exercise facilities up to three days per week for four weeks during cycle 0, two days per week for cycles 1-8(32 weeks) and once per week for cycles 9-11 (12 weeks). In addition, patients must be able to attend exercise testing visits as outlined in the Table 1.Required Initial
- Absolute neutrophil count (ANC) ≥ 1500/uL
- Platelet count ≥ 100,000/uL
- Creatinine ≤ 1.5 x upper limits of normal
- Bilirubin ≤ 1.5 x upper limits of normal
- Aspartate aminotransferase (AST) ≤ 1.5 x upper limits of normal
- PSA ≥ 2 ng/ml
- Serum testosterone ≤ 50 ng/dL
Medical clearance to undergo a symptom-limited cardiopulmonary exercise test (CPET)and vigorous aerobic and resistance exercise training.
o Appendix 8: Patients must answer 'No' to all questions. If patients answered 'Yes'to only Questions 8-11, they will be considered eligible upon physician clearance
Successfully pass the screening CPET by achieving:
o Volitional exhaustion (RPE ≥ 9 using the 0-10 RPE scale) after 8 (or more) minutes,in the absence of any cardiorespiratory abnormalities.
- If cardiorespiratory abnormalities are identified, please refer the patient to his managing physician for further assessment and diagnosis.
- Note: To assist practitioners with delivering valid CPET assessments, patients nearing exhaustion should achieve a respiratory exchange ratio (RER) of ≥1.1.
- RER is not a criteria of the test. This objective measure should only be used to assist practitioners with patient management and decision-making.
- Exercise Coordination Centre (ECC) review and approval of subject's screening bone scan/ areas with bone metastases.
- Subject is willing and able to use the technological aspects of the trial.
- The subject is fluent in the language as designated by the institution at which he would be enrolled.
You CAN'T join if...
- Previous progression (radiographic or PSA progression) while on treatment with abiraterone, enzalutamide, 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)
- Any prior chemotherapy for castration-resistant disease is not allowed. 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 < 160/90,regardless of whether on a regimen of anti-hypertensive therapy or not.
- Current congestive heart failure (New York Heart Association Class II, III or IV)
- Recent serious cardiovascular events (within 12 months) including, but not limited to,transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI).
- Medical condition such as uncontrolled infection or cardiac disease that, in the opinion of the physician, would make this protocol unreasonably hazardous for the patient (see Section 4.4-4.10).
- Patients with a currently active second malignancy other than non-melanoma skin cancer. Patients are not considered to have a currently active malignancy if they have completed necessary therapy and are considered by their physician to be at <30% risk of relapse at time of assessment.
- Psychiatric illness, which would prevent the patient from giving informed consent or adhering to the study protocol.
- Serious or non-healing wound, ulcer, or bone fracture.
- Known spinal cord compromise or instrumentation due to metastatic disease. Radiation therapy for metastatic disease is allowed.
- Peripheral neuropathy ≥grade 3.
- Men participating in vigorous aerobic exercise for more than 60 minutes per week or resistance exercise two or more days per week
- Experiences shortness of breath, chest discomfort, or palpitations when performing activities of daily living
- Has difficulty climbing a flight of stairs or walking eight blocks due to physical impairment
- Ongoing restriction of physical activity with physician documentation
- Has chest pain brought on by physical activity
- Has developed chest pain in the past month
- 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 Food Frequency Questionnaire (FFQ) (TBD) will not be eligible
- UCSF not yet accepting patients
San Francisco, California, United States
- Cedars Sinai Medical Centre not yet accepting patients
Los Angeles, California, United States
- accepting new patients
- Start Date
- Movember Foundation
- Phase 3
- Study Type
- Last Updated
- June 2016