INTERVAL - Intense Exercise Trial for Men With Metastatic Castrate-Resistant Prostate Cancer (INTERVAL)
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|ClinicalTrials.gov Identifier: NCT04507698|
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : August 11, 2020
Exercise has been established to be safe and result in improved physical function and quality of life for most individuals with cancer. However, little information exists regarding whether exercise can increase overall survival and reduce disease progression, events related to cancer spreading to the bones (e.g. bone fracture, spinal cord compression, extra radiation or surgery), and pain in patients with metastatic prostate cancer that is no longer responding to hormone therapy. The primary objective of this study is to determine if high intensity aerobic and resistance training plus psychosocial support increases overall survival compared to psychosocial support alone in prostate cancer patients.
The Movember foundation is providing support for the conduct of this study
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Intensive Exercise Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||INTense Exercise foR surVivAL Among Men With Metastatic Castrate-Resistant Prostate Cancer (INTERVAL - MCRPC): A Multicentre, Randomised, Controlled, Phase III Study|
|Actual Study Start Date :||September 1, 2017|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2024|
Experimental: Supervised Exercise Arm
If participants are placed in the Supervised Exercise Group, they will attend supervised group exercise sessions, which are individually tailored to the participants physical condition, at least once a week, every week for the first year of the study. They will be asked to exercise 3 times a week.
Other: Intensive Exercise Intervention
INTense Exercise foR surVivAL among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL - MCRPC), randomised to either the supervised exercise arm or the self-directed exercise arm.
No Intervention: Self-Directed Exercise Arm
If Participants are placed in the Self-directed Exercise Group, they will receive usual medical care (standard of care) and be asked to follow their usual exercise and lifestyle routine. They will receive supportive care in the form of newsletters, covering a variety of topics including pain management, bone health, goal setting, taking control of life, and more.
- Overall Survival [ Time Frame: 24 months ]Patients will be followed for death a minimum of 36 months after randomisation. Overall survival will be measured from the time of randomisation until death. Medical records and death certificates will be reviewed every 6 months to obtain survival status. Country-specific mortality status databases will also be searched annually; cause of death will be determined through review of medical and death records. Patients will be contacted once a year, and follow up with next of kin then alternate contact, if needed, if we do not hear from them.
- Disease progression [ Time Frame: 24 months ]
Progression will be determined by the treating physician, and may include any of the following, based on PCWG-3 and RECIST 1.1 criteria:
- Bone scan: Appearance of ≥ 2 new lesions on bone scan, if bone scan >12 weeks after randomisation
- CT/MRI: ≥ 20% increase in the sum of diameters, taking the reference as the smallest sum on study. In addition to the relative increase by 20%, the sum must also demonstrate an absolute increase >5 mm / appearance of one or more new lesions / Unequivocal progression of baseline unmeasurable lesions.
- initiating a new therapy for MCRPC
- Symptomatic-skeletal related event (SSE). Progression free survival will be measured from randomisation 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 SSE.
CT Scan Progression of Non-measurable Lesions Progression will be defined based on PCWG;-3 and RECIST 1.1 as all other lesions, including
- Symptomatic Skeletal Related Events [ Time Frame: 24 months ]
Time to first occurrence of SSE will be defined as the time from randomisation 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
Adverse event, concomitant medication, concomitant treatment, or survival follow-up CRFs and the participant's medical record will be the source of these findings and presented as categorical data.
- Analgesic/Opiate Use [ Time Frame: 24 months ]
Analgesic/opiate use will be assessed via Brief Pain Inventory - Short Form (BPI-SF) questionnaire and 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 BPI-SF questionnaires will be administered every three cycles until month 24, and yearly thereafter.
BPI-SF scoring:Score: 1 - 4 = Mild Pain, Score: 5 - 6 = Moderate Pain, Score: 7 - 10 = Severe Pain.
WHO scoring: 1 = non-opiods (e. g. acetaminophen), 2 = as necessary, mild opiods (e. g. codeine), 3 = then strong opiods (e. g. morphine or hydromorphone) until the patient is free of pain.
- Metabolic Biomarkers [ Time Frame: 24 months ]Inflammatory and cytokine systemic milieu: Serum/plasma aliquots (baseline and cycle 6) from all patient samples are intended for interrogation of a panel of markers associated with inflammation including IL1β, IL-2, IL-6, TNFα and adiponectin. Results from these investigations will be correlated with c-reactive protein and measured outcomes of exercise response and disease progression. Insulin/Glucose Metabolism: Serum aliquots (baseline and cycle 6) from all patient samples are intended for assessment of insulin levels by e.g. enzyme-linked immunosorbent assay (ELISA). Insulin sensitivity will be calculated using these fasting serum insulin values and plasma glucose determinations obtained in the additional clinical blood assessments, where the HOMA-IR method will be applied. C-peptide will also be assessed. Androgen biosynthesis: Serum aliquots from all patient samples at baseline are intended for assessment of androgen levels (Testosterone, DHT, androstenedione, DHEA, 17-hydroxy.
- Physical Function [ Time Frame: 24 months ]Physical function will be assessed using strength assessments (1RM), a cardiopulmonary exercise test (CPET) and a functional performance test (400m walk). Strength assessments will be quantified in kilograms lifted, and will be dependent upon the location and size of bone metastatic lesions present as to which tests are performed (Chest Press, Leg Press, Seated Row and Leg Extension). All strength assessments should be attempted if not contraindicated. Cardiopulmonary exercise capacity will be quantified by VO2peak (L.min and mL/(kg·min)) and workload achieved (watts) during a successful CPET (RPE ≥
- Quality of Life - Patient Reported Outcome Measures [ Time Frame: 24 months ]Symptoms will be considered independently of other outcome measures. Pain will be assessed via BPI-SF and medical record review at entry with a lead-in period (<28 days) and repeated measures will occur every three cycles. Changes occurring within 12 weeks of study initiation will be ignored in the absence of compelling evidence of disease progression. Response or progression of pain will be confirmed through repeat assessments separately by at least three weeks. Quality of life measured by the FACT-G, FACIT-Fatigue, QLQ-C30, EPIC-26, and EQ5D will be assessed every 3 cycles.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04507698
|Contact: Harriet Wyliefirstname.lastname@example.org|
|Queens University Belfast||Recruiting|
|Belfast, Northern Ireland, United Kingdom|
|Contact: Joe O'Sullivan email@example.com|
|Contact: Mal Brown firstname.lastname@example.org|
|University of Glasgow||Recruiting|
|Glasgow, United Kingdom|
|Contact: Hing Leung email@example.com|
|Contact: Christian Delles firstname.lastname@example.org|
|Guy's and St Thomas's NHS Trust||Recruiting|
|London, United Kingdom, SE1 9RT|
|Contact: Harriet Wylie 07464492509 email@example.com|
|Contact: Anna Haire 07464492509 firstname.lastname@example.org|
|University of Surrey||Recruiting|
|London, United Kingdom|
|Contact: Harry Roberts email@example.com|
|Contact: Ralph Manders firstname.lastname@example.org|