A Phase III clinical trial of high-intensity exercise in the management of advanced prostate cancer

According to a news release just issued by Queen’s University, Belfast, a group of  150 researchers around the world is coming together to expand enrollment and access to the Australian INTERVAL trial into a global trial to test whether serious exercise should be prescribed as part of the treatment for men with advanced prostate cancer.

The INTERVAL-mCRPC trial (properly known as the INTense Exercise foR surVivAL among men with Metastatic Castrate-Resistant Prostate Cancer trial) was initiated in Australia back in 2016. The trial is described as a randomized, controlled trial designed to find out whether high-intensity aerobic and resistance exercise along with psychosocial support could increase overall survival compared to psychosocial support alone in patients with mCRPC.  Other secondary endpoints include things like time to different types of disease progression between the exercise group and the control group of patients, the impact on different types of biomarkers, and effects on quality of life.

Earlier pilot research carried out in Australia (see here) has already shown that high-intensity exercise (in combination with other forms of therapy) has the potential to extend the lives of men with advanced prostate cancer — while simultaneously preserving physical function and improving quality of life.

According to the new media release from Queens University, Belfast, it appears that the INTERVAL-mCRPC trial is being extended to enroll patients in parts of Europe and North America (and Queens University in Belfast will be one of the new European sites enrolling patients). The expanded trial will

  • Enroll 866 patients with advanced prostate cancer across three continents
  • Prescribe high-intensity exercise (tailored to the level of fitness of individual participants) alongside traditional treatments such as radiotherapy, androgen deprivation therapy (ADT), and chemotherapy for a randomized group of these men
  • Test, in a rigorous manner, whether high-intensity aerobic and resistance training alongside “standard” forms of psycho-social support offered to prostate cancer patients will lead to increased overall survival
  • Collect relevant medical, biological, and biochemical data to support study of secondary trial endpoints

Clearly, not all men with advanced prostate cancer will be suitable candidates for inclusion in this trial. Many men with advanced prostate cancer may have other co-morbid conditions that make high-intensity exercise either impossible or difficult. Thus (at least at Queens University, Belfast) there is also going to be a concomitant low-intensity exercise initiative (a walking program) in which men who are not good candidates for this global trial of high-intensity exercise may be able to participate.

The INTERVAL-mCRPC trial is being led and funded globally by the Movember Foundation and it is a part of initiatives included under Movember’s Global Action Plan 4.

As yet we are not specifically aware of any sites in the USA that will be enrolling patients, but we will see what we can find out.

4 Responses

  1. According to the ClinicalTrials.gov record for NCT02730338, the following sites in North America are currently recruiting patients:

    • Cedars Sinai Medical Centre / Los Angeles, CA
    • Oregon Health & Science University / Portland, OR
    • University of Alberta / Edmonton, Alberta

  2. Thanks Paul. When I had searched ClinicalTrials.gov for this trial yesterday (using a variety of different search strategies) it didn’t show up at all (which only goes to show that using the ClinicalTrials.gov site is an art rather than a science!).

    I note that several other North American sites are “not yet recruiting” patients, but presumably they will be in the not too distant future. These include:

    — UCSF / San Francisco, CA
    — University of Colorado / Denver, CO
    — Fred Hutchinson Cancer Center / Seattle, WA
    — Princess Margaret Cancer Center / Toronto, ON
    — Centre Hospitalier de l’Université de Montréal (CRCHUM) / Montreal, QC

  3. A concern in trial design is how this can be truly random. Are they planning on forbidding men in the control group from exercising? Then we may find out later that occasionally they took a walk, or a bike ride etc. And surely it is unethical to restrict a man with advanced PCa from exercise.

    This reminds me a bit of the PSA trial where we learnt later that some men changed their minds and sought out a test.

  4. Dear Rick:

    Since one of the recruiting sites is UCSF, I suggest you go talk to your friends there to find out exactly what is involved in ensuring the exercise levels for the high-intensity exercise group. If your look at the study protocol you will see that all men in the high-intensity exercise group are required to attend designated exercise sites for up to three times a week over the course of a year so that their exercise levels can be appropriately supervised and monitored.

    I am quite sure that it was never the intent to “ban” people in the control group from exercising. They simply don’t get any form of encouragement or active oversight of any exercise they may want to take. Most people’s idea of “exercise” at age 60+ is pretty limited. High-intensity exercise means dripping with sweat for a minimum of 30 minutes.

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