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

NCT02730338 | Active Not Recruiting DMC

• 1 other identifier: GAP4
• Study Type: interventional
• Target: 866
• Locations: 6 countries
• Sites: 18

Brief 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.

Conditions

Metastatic Prostate Cancer

Keywords

Castrate resistant; Exercise; Metastatic; Prostate cancer; Hormone sensitive

Outcome Measures

Primary Outcomes (1)

• Overall Survival

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

  up to 5 years

Secondary Outcomes (10)

• Disease Progression

  up to 5 years

• Symptomatic Skeletal Related Events (SSE)

  up to 5 years

• Opiate Use

  up to 5 years

• Analgesic Use

  up to 5 years

• Biomarker analysis

  up to 5 years

Study Arms (2)

Arm A: Supervised exercise group

ACTIVE COMPARATOR

Supervised high intensity aerobic and resistance exercise tapering to self management with psychosocial support

Behavioral: High intensity aerobic and resistance training; Behavioral: Psychosocial support

Arm B: Self directed exercise group

OTHER

Self directed exercise and psychosocial support group

Behavioral: Psychosocial support

Interventions

High intensity aerobic and resistance training BEHAVIORAL

Arm A: Supervised exercise group

Psychosocial support BEHAVIORAL

Arm A: Supervised exercise group; Arm B: Self directed exercise group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• Movember Foundation: lead
• University of California, San Francisco: collaborator
• Edith Cowan University: collaborator
• King's College London: collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator

Study Sites (18)

Cedars Sinai Medical Centre

Los Angeles, California, United States

Location

UCSF

San Francisco, California, United States

Location

UC Denver

Denver, Colorado, United States

Location

University of Minnesota

Minneapolis, Minnesota, United States

Location

Oregon Health & Science University

Portland, Oregon, United States

Location

Fred Hutchinson Cancer Centre

Seattle, Washington, United States

Location

Australian Prostate Cncr Research Centre

Brisbane, Queensland, Australia

Location

University of Queensland

Brisbane, Queensland, Australia

Location

Victoria University / Sunshine Hospital

Melbourne, Victoria, Australia

Location

Edith Cowan University

Perth, Western Australia, Australia

Location

University of Alberta

Edmonton, Alberta, Canada

Location

Centre Hospitalier de l'Université de Montréal (CRCHUM)

Montreal, Canada

Location

German Sport University Cologne

Cologne, Germany

Location

Erasmus MC

Rotterdam, Netherlands

Location

University of Surrey

Guildford, Surrey, United Kingdom

Location

Queen's University Belfast

Belfast, United Kingdom

Location

University of Glasgow

Glasgow, United Kingdom

Location

Kings College London

London, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 39632499 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.

  PMID: 38951803 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.

  PMID: 29764892 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Motor Activity; Neoplasm Metastasis

Interventions

Resistance Training; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Behavior; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Robert Newton

  Edith Cowan University

  STUDY CHAIR

• Fred Saad

  Centre hospitalier de l'Université de Montréal (CHUM)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: April 6, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 27, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4); US (6); DE (1); AU (4); CA (2); NL (1)