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

Running, not enrolling · Not applicable

Conditions studied: Metastatic Prostate Cancer

In brief

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

Key facts

Study ID

NCT02730338

Run by

Movember Foundation

People needed

866

Starts

2016-01-01

Expected to finish

2026-10-01

Last updated by the study team

2024-11-27

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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)
• 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.

Where it is running

• Cedars Sinai Medical Centre — Los Angeles, California, United States
• UCSF — 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.