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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
| Edith Cowan University | OTHER |
| King's College London | OTHER |
| Centre hospitalier de l'Université de Montréal (CHUM) |
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To determine if supervised high intensity aerobic and resistance training increases overall survival compared to self-directed exercise in patients with metastatic prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Supervised exercise group | Active Comparator | Supervised high intensity aerobic and resistance exercise tapering to self management with psychosocial support |
|
| Arm B: Self directed exercise group | Other | Self directed exercise and psychosocial support group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High intensity aerobic and resistance training | Behavioral |
| ||
| Psychosocial support |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival will be measured from the time of randomization until death | up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Progression | 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 mPC (clinical progression), or first occurrence of a Symptomatic Skeletal Related Event (SSE). | up to 5 years |
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Inclusion Criteria:
mCRPC status:
mCRPC patients defined as; adenocarcinoma of the prostate with systemic metastatic disease despite castrate levels of testosterone (<50 ng/dL) due to orchiectomy or LHRH agonist.
o Patients must have one or more of the following to be considered mCRPC
Metastatic 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.
PSA Progression: PSA ≥2 ng/ml that has risen serially on at least two occasions, each at least one week apart (PSA1 < PSA2 < PSA3).
PSMA PET/CT scan progression: Appearance of one or more new lesions on PSMA PET/CT scan attributable to prostate cancer.
At enrolment, mCRPC patients must fit into one of the following 5 categories:
Treatment naïve for mCRPC (have not yet started approved therapies for CRPC ie: Abiraterone/Enzalutamide/Apalutamide / or Docetaxel, Cabazitaxel or other approved first line chemotherapy; less than 4 weeks on approved therapies is still considered to be treatment naïve) Or
Receiving Abi/Enza/Apa for mCRPC AND responding or stable (PSA values must be stable or declining after at least 4 weeks since starting Abi/Enza/Apa for mCRPC) Or
Patients with PSA progression while on Abi/Enza/Apa are eligible as long as they are asymptomatic AND there is no intent on starting chemotherapy within 6 months Or
Patients treated with Docetaxel, Cabazitaxel or other approved first line chemotherapy as first line for mCRPC who are asymptomatic without ANY evidence of progression Or
Patients may have progressed following first line Docetaxel, Cabazitaxel or other first line chemotherapy and are now receiving treatment with Abi/Enza/Apa. These patients must absolutely be responding or stable (PSA values must be stable or declining after starting Abi/Enza/Apa treatment) and have an estimated life expectancy of more than 1 year.
mHSPC Status:
mHSPC patients must be classified as either high-risk or high-volume mHSPC. These groups are defined as adenocarcinoma of the prostate with systemic metastatic disease and patients also fit into one of the following 2 categories: 6. High-risk: defined as having at least 2 of three criteria: (i) Gleason score ≥8, (ii) presence of ≥3 lesions on bone scan, or (iii) presence of INTERVAL Protocol Version 5.0, 19 August 2019 4 measurable visceral lesions (PSMA PET imaging should not be used in the definition of high-risk disease) Or 7. High-volume: defined as having the presence of visceral metastases and/or ≥ four bone metastases with at least one outside of the vertebral column and pelvis (PSMA PET imaging should not be used in the definition of high-volume disease)
Additional criteria for all groups:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Newton | Edith Cowan University | Study Chair |
| Fred Saad | Centre hospitalier de l'Université de Montréal (CHUM) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Centre | Los Angeles | California | United States | |||
| UCSF |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39632499 | Derived | Umlauff L, Kenfield SA, Newton RU, Hart NH, Saad F, Courneya KS, Greenwood R, Bloch W; INTERVAL-GAP4 Steering Committee/Coordinating Centres Members/Protocol Development Working Group Members; Schumann M. Meeting Aerobic Physical Activity Guidelines and Associations With Physical Fitness in Men With Metastatic Prostate Cancer: Baseline Results of the Multicentre INTERVAL-GAP4 Trial. Cancer Med. 2024 Dec;13(23):e70261. doi: 10.1002/cam4.70261. | |
| 38951803 |
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| OTHER |
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| Behavioral |
|
| Symptomatic Skeletal Related Events (SSE) |
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:
|
| up to 5 years |
| Opiate Use | 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. | up to 5 years |
| Analgesic Use | 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. | up to 5 years |
| Biomarker analysis | Inflammatory and cytokine systemic milieu | up to 5 years |
| Biomarker analysis | Insulin/Glucose Metabolism | up to 5 years |
| Biomarker analysis | Androgen biosynthesis | up to 5 years |
| Quality of Life | Physical and emotional 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. | up to 5 years |
| Physical Function | Physical function will be assessed using strength assessments (1RM), a cardiopulmonary exercise test (CPET) and a functional performance test (400m walk) | up to 5 years |
| Pain | 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 | up to 5 years |
| San Francisco |
| California |
| United States |
| UC Denver | Denver | Colorado | United States |
| University of Minnesota | Minneapolis | Minnesota | United States |
| Oregon Health & Science University | Portland | Oregon | United States |
| Fred Hutchinson Cancer Centre | Seattle | Washington | United States |
| Australian Prostate Cncr Research Centre | Brisbane | Queensland | Australia |
| University of Queensland | Brisbane | Queensland | Australia |
| Victoria University / Sunshine Hospital | Melbourne | Victoria | Australia |
| Edith Cowan University | Perth | Western Australia | Australia |
| University of Alberta | Edmonton | Alberta | Canada |
| Centre Hospitalier de l'Université de Montréal (CRCHUM) | Montreal | Canada |
| German Sport University Cologne | Cologne | Germany |
| Erasmus MC | Rotterdam | Netherlands |
| University of Surrey | Guildford | Surrey | United Kingdom |
| Queen's University Belfast | Belfast | United Kingdom |
| University of Glasgow | Glasgow | United Kingdom |
| Kings College London | London | United Kingdom |
| Derived |
| Kim JS, Taaffe DR, Galvao DA, Clay TD, Redfern AD, Gray ES, Newton RU. Enhancing circulatory myokines and extracellular vesicle uptake with targeted exercise in patients with prostate cancer (the MYEX trial): a single-group crossover study. BMC Cancer. 2024 Jul 1;24(1):784. doi: 10.1186/s12885-024-12530-0. |
| 29764892 | Derived | Newton RU, Kenfield SA, Hart NH, Chan JM, Courneya KS, Catto J, Finn SP, Greenwood R, Hughes DC, Mucci L, Plymate SR, Praet SFE, Guinan EM, Van Blarigan EL, Casey O, Buzza M, Gledhill S, Zhang L, Galvao DA, Ryan CJ, Saad F. Intense Exercise for Survival among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL-GAP4): a multicentre, randomised, controlled phase III study protocol. BMJ Open. 2018 May 14;8(5):e022899. doi: 10.1136/bmjopen-2018-022899. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D009043 | Motor Activity |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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