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Metastatic Prostate CancerINTERVALNCT02730338

INTense ExeRcise for SurviVAL Among Men with Metastatic Prostate Cancer (INTERVAL - GAP4)

A study testing High intensity aerobic and resistance training and Psychosocial support in people with Metastatic Prostate Cancer, run by Movember Foundation at 18 sites in 6 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To determine if supervised high intensity aerobic and resistance training increases overall survival compared to self-directed exercise in patients with metastatic prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Prostate Cancer
What is being tested?
High intensity aerobic and resistance training and Psychosocial support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
866 participants
Where
18 sitesin 6 countries
Study dates
Jan 2016to Oct 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 29Show fewer
  • 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:
  • All patients will be required to be on ADT during the study period or have had a prior bilateral orchiectomy.
  • Men with small cell neuroendocrine tumours or features of small cell disease are not eligible.
  • ≥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 (< 160/90) on anti-hypertensive therapy.
  • Halabi Nomogram score <1951 (Risk Category rated as low or intermediate risk)
  • Age ≥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 Coordination Centre (ECC) review and approval of subject's screening bone scan / areas with bone metastases.
  • Men participating in vigorous aerobic exercise for >60 min/week or structured resistance exercise ≥2 days/week, are not eligible.
  • Subject is willing and able to use technological aspects of the trial.
  • The subject is fluent in the language as designated by the institution at which he would be enrolled.

Who cannot join

None listed.

Trial locations and contacts

18 sites in 6 countries.

18 sites in 6 countries

United States6 sites

  • UC Denver

    Denver, Colorado

  • Cedars Sinai Medical Centre

    Los Angeles, California

  • University of Minnesota

    Minneapolis, Minnesota

  • Oregon Health & Science University

    Portland, Oregon

  • UCSF

    San Francisco, California

  • Fred Hutchinson Cancer Centre

    Seattle, Washington

Other trials in United States

Australia4 sites

  • Australian Prostate Cncr Research Centre

    Brisbane, Queensland

  • University of Queensland

    Brisbane, Queensland

  • Victoria University / Sunshine Hospital

    Melbourne, Victoria

  • Edith Cowan University

    Perth, Western Australia

Other trials in Australia

United Kingdom4 sites

  • Queen's University Belfast

    Belfast

  • University of Glasgow

    Glasgow

  • University of Surrey

    Guildford, Surrey

  • Kings College London

    London

Other trials in United Kingdom

Canada2 sites

  • University of Alberta

    Edmonton, Alberta

  • Centre Hospitalier de l'Université de Montréal (CRCHUM)

    Montreal

Other trials in Canada

Germany1 site

  • German Sport University Cologne

    Cologne

Other trials in Germany

Netherlands1 site

  • Erasmus MC

    Rotterdam

Other trials in Netherlands

About this study

Official title: INTense ExeRcise for SurviVAL Among Men with Metastatic Prostate Cancer (INTERVAL - GAP4): a Multicentre, Randomised, Controlled, Phase III Study

To determine if supervised high intensity aerobic and resistance training increases overall survival compared to self-directed exercise in patients with metastatic prostate cancer.

Being tested
High intensity aerobic and resistance training, Psychosocial support
Keywords
Castrate resistant, Exercise, Metastatic, Prostate cancer, Hormone sensitive
Medical subject headings
Prostatic Neoplasms, Motor Activity, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High intensity aerobic and resistance trainingBehavioural

  • Psychosocial supportBehavioural

Study groups in NCT02730338
Study groupRoleWhat they receive
Arm A: Supervised exercise groupActive comparatorSupervised high intensity aerobic and resistance exercise tapering to self management with psychosocial support
Receives: Behavioral: High intensity aerobic and resistance training; Behavioral: Psychosocial support
Arm B: Self directed exercise groupOtherSelf directed exercise and psychosocial support group
Receives: Behavioral: Psychosocial support

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Overall survival will be measured from the time of randomization until death

    Measured: up to 5 years

Secondary outcomes (10)

  1. 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).

    Measured: up to 5 years

  2. 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:

    • 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

    Measured: up to 5 years

  3. 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.

    Measured: up to 5 years

  4. 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.

    Measured: up to 5 years

  5. Biomarker analysis

    Inflammatory and cytokine systemic milieu

    Measured: up to 5 years

  6. Biomarker analysis

    Insulin/Glucose Metabolism

    Measured: up to 5 years

  7. Biomarker analysis

    Androgen biosynthesis

    Measured: up to 5 years

  8. 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.

    Measured: up to 5 years

  9. Physical Function

    Physical function will be assessed using strength assessments (1RM), a cardiopulmonary exercise test (CPET) and a functional performance test (400m walk)

    Measured: up to 5 years

  10. 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

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionOct 2025 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
866 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02730338
Sponsor's protocol ID
GAP4
Acronym
INTERVAL
Status last verified
Mar 2023
First submitted
10 Mar 2016
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39632499

  • 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.

    PubMed 38951803

  • 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.

    PubMed 29764892

Questions about this trial

What is this clinical trial studying?

A study testing High intensity aerobic and resistance training and Psychosocial support in people with Metastatic Prostate Cancer, run by Movember Foundation at 18 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 29 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States, Australia, United Kingdom, Canada, Germany and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02730338, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.

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