Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Stacey Kenfield

Description

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.

Official Title

INTense ExeRcise for surviVAL Among Men With Metastatic Prostate Cancer (INTERVAL - GAP4): A Multicentre, Randomised, Controlled, Phase III Study

Keywords

Metastatic Prostate Cancer Castrate resistant Exercise Metastatic Prostate cancer Hormone sensitive Prostatic Neoplasms High intensity aerobic and resistance training Psychosocial support

Eligibility

For males ages 18 years and up

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:

  • 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
  • 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.

Locations

  • UCSF not yet accepting patients
    San Francisco California United States
  • Cedars Sinai Medical Centre in progress, not accepting new patients
    Los Angeles California United States

Lead Scientist at UCSF

  • Stacey Kenfield
    Associate Professor, Urology. Authored (or co-authored) 88 research publications.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Movember Foundation
ID
NCT02730338
Study Type
Interventional
Last Updated