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INTense Exercise foR surVivAL Among Men With Metastatic Castrate-Resistant Prostate Cancer (INTERVAL)

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by Movember Foundation
Sponsor:
Collaborators:
University of California, San Francisco
Edith Cowan University, Australia
King's College London
Centre hospitalier de l'Université de Montréal (CHUM)
Information provided by (Responsible Party):
Movember Foundation
ClinicalTrials.gov Identifier:
NCT02730338
First received: March 10, 2016
Last updated: September 7, 2017
Last verified: September 2017
  Purpose
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.

Condition Intervention
Prostate Cancer Metastatic Behavioral: High intensity aerobic and resistance training Behavioral: Psychosocial support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: INTense Exercise foR surVivAL Among Men With Metastatic Castrate-Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Movember Foundation:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: up to 3 years ]
    Overall survival will be measured from the time of randomization until death


Secondary Outcome Measures:
  • Disease Progression [ Time Frame: up to 3 years ]
    Time to disease progression will be measured from randomization until the first of the following: first CT or bone scan documenting disease progression, initiation of a new therapy for MCRPC (clinical progression), or first occurrence of a Symptomatic Skeletal Related Event (SSE).

  • Symptomatic Skeletal Related Events (SSE) [ Time Frame: up to 3 years ]

    Time to first occurrence of SSE will be defined as the time from randomization to documentation of any of the following (whichever occurs first) + 1 day:

    • Use of external beam radiation therapy to relieve bone pain
    • Occurrence of new symptomatic pathological bone fractures that may be vertebral or non-vertebral. Asymptomatic compression fractures detected by radiology review only will not be considered a SSE.
    • Spinal cord compression
    • Change in antineoplastic therapy to treat bone pain
    • Surgical intervention to treat bone pain

  • Opiate Use [ Time Frame: up to 3 years ]
    Opiate use will be assessed via BPI-SF, the medical record review at entry with a lead-in period (<28 days). The questionnaires will be administered every three cycles until month 24, and in month 36.

  • Analgesic Use [ Time Frame: up to 3 years ]
    Analgesic use will be assessed via BPI-SF, the World Health Organisation (WHO) analgesic scale, and medical record review at entry with a lead-in period (<28 days). The WHO analgesic scale will be completed every three cycles (based on medical review) and questionnaires will be administered every three cycles until month 24, and in month 36.

  • Biomarker analysis [ Time Frame: up to 3 years ]
    Inflammatory and cytokine systemic milieu

  • Biomarker analysis [ Time Frame: up to 3 years ]
    Insulin/Glucose Metabolism

  • Biomarker analysis [ Time Frame: up to 3 years ]
    Androgen biosynthesis

  • Quality of Life [ Time Frame: up to 3 years ]
    Quality of life measured by the questionnaires- Functional Assessment of Cancer Therapy- Prostate (FACT-P), Functional assessment of Chronic Illness Therapy (FACIT-Fatigue), and EuroQOL Five Dimension Questionnaire (EQ5D) will be assessed every 3 cycles.

  • Physical Function [ Time Frame: up to 3 years ]
    Physical function will be assessed using strength assessments (1RM), a cardiopulmonary exercise test (CPET) and a functional performance test (400m walk)

  • Pain [ Time Frame: up to 3 years ]
    Pain will be assessed via questionnaire Brief Pain Inventory- short form (BPI-SF) and medical record review at entry with a lead-in period (<28 days) and repeated measures will occur every three cycles


Estimated Enrollment: 866
Actual Study Start Date: December 2015
Estimated Study Completion Date: December 2022
Estimated Primary Completion Date: December 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Exercise Group
High intensity aerobic and resistance training- supervised exercise tapering to self management with psychosocial support
Behavioral: High intensity aerobic and resistance training Behavioral: Psychosocial support
Control Group
Psychosocial support only
Behavioral: Psychosocial support

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Laboratory Values:

    • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02730338

Locations
United States, California
Cedars Sinai Medical Centre Recruiting
Los Angeles, California, United States
Contact: Stephen Freedland       Stephen.Freedland@cshs.org   
UCSF Not yet recruiting
San Francisco, California, United States
Contact: Charles Ryan         
Sub-Investigator: June Chan         
United States, Colorado
UC Denver Not yet recruiting
Denver, Colorado, United States
Contact: Elizabeth Kessler         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States
Contact: Kerri Winters-Stone       wintersk@ohsu.edu   
United States, Washington
Fred Hutchinson Cancer Centre Not yet recruiting
Seattle, Washington, United States
Contact: Stephen Plymate         
Australia, Queensland
Australian Prostate Cncr Research Centre Recruiting
Brisbane, Queensland, Australia
Contact: Colleen Nelson       colleen.nelson@qut.edu.au   
Australia, Victoria
Deakin University Not yet recruiting
Boxhill, Victoria, Australia
Contact: Aaron Russell         
Australia, Western Australia
Edith Cowan University Recruiting
Perth, Western Australia, Australia
Contact: Robert Newton       r.newton@ecu.edu.au   
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada
Contact: Kerry Courneya       kerry.courneya@ualberta.ca   
Canada, Ontario
Princess Margaret Cancer Centre Not yet recruiting
Toronto, Ontario, Canada
Canada
Centre Hospitalier de l'Université de Montréal (CRCHUM) Not yet recruiting
Montreal, Canada
Contact: Fred Saad       fred.saad@umontreal.ca   
Germany
German Sport University Cologne Recruiting
Cologne, Germany
Contact: Wilhelm Bolch       w.bloch@dshs-koeln.de   
Ireland
Trinity University Not yet recruiting
Dublin, Ireland
Contact: Stephen Finn         
Netherlands
Erasmus MC Not yet recruiting
Rotterdam, Netherlands
Contact: Monique Roobol         
United Kingdom
University of Surrey Not yet recruiting
Guildford, Surrey, United Kingdom
Contact: Ralph Manders         
Queen's University Belfast Not yet recruiting
Belfast, United Kingdom
Contact: Joe O'Sullivan         
Bristol Urology Not yet recruiting
Bristol, United Kingdom
Contact: Raj Persad         
University of Glasgow Not yet recruiting
Glasgow, United Kingdom
Contact: Hing Leung         
Kings College London Not yet recruiting
London, United Kingdom
Contact: Mieke Van Hemelrijck         
Sponsors and Collaborators
Movember Foundation
University of California, San Francisco
Edith Cowan University, Australia
King's College London
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
Study Chair: Robert Newton Edith Cowan University
Study Chair: Fred Saad Centre Hospitalier de l¹Université de Montréal (CRCHUM)
  More Information

Responsible Party: Movember Foundation
ClinicalTrials.gov Identifier: NCT02730338     History of Changes
Other Study ID Numbers: GAP4
Study First Received: March 10, 2016
Last Updated: September 7, 2017

Keywords provided by Movember Foundation:
Castrate-Resistant

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 21, 2017