Active not recruitingNAINTERVENTIONAL

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

The INTERVAL study aims to find out if a structured, intense exercise program can improve how long men with prostate cancer that has spread (metastatic prostate cancer) live. This program includes both strong aerobic exercises (like brisk walking or cycling) and resistance training (like lifting weights), along with emotional and social support. Researchers want to see if this guided approach is better than patients doing their own exercise without specific guidance. This study is important because it could show a new way for men with advanced prostate cancer to feel better and potentially live longer, by focusing on the power of exercise.

At a glance

Status

Active not recruiting

Phase

Sponsor

Movember Foundation

Enrolment target

866

Start

01 Jan 2016

Estimated completion

01 Oct 2026

Metastatic Prostate Cancer

What is this study about?

This study, called INTERVAL, is looking into how exercise can play a role in the lives of men with advanced prostate cancer. This is prostate cancer that has spread to other parts of the body, even after initial treatments. The main goal is to see if a dedicated, supervised exercise program can help men live longer compared to those who do their own exercise.

The exercise program in this study is quite intensive. It includes two main types of exercise: aerobic exercise, which gets your heart rate up (like running or swimming), and resistance training, which builds muscle (like lifting weights). Alongside the physical exercise, participants will also receive emotional and social support, which is often very helpful when dealing with a serious illness. This combination is designed to be a comprehensive approach to well-being.

By comparing men who follow this structured program with those who continue with their usual, self-guided exercise routines, the researchers hope to understand if a targeted exercise approach can make a significant difference to overall health and how long men with this type of prostate cancer live. If successful, this could offer a new and empowering way for patients to actively participate in their treatment and improve their quality of life.

Key takeaways

This study explores if intense exercise can help men with advanced prostate cancer live longer.
It involves a structured program of aerobic and resistance exercises, plus emotional support.
You would either follow a supervised exercise plan or continue with your own activities.
Participation requires your prostate cancer to have spread and be actively monitored or treated.
The study aims to improve health and survival outcomes through physical activity.

Who may be eligible?

To join this study, you need to be a man with prostate cancer that has spread to other parts of your body. This means your cancer is advanced and hasn't responded to initial hormone therapy that lowers your testosterone.

Your doctor will need to confirm that your cancer is currently active and spreading. This might be shown by new spots appearing on scans (like bone scans or PSMA PET/CT scans), or by your PSA blood test levels going up steadily. Even if you're already receiving treatments like Abiraterone, Enzalutamide, Apalutamide, or chemotherapy (like Docetaxel or Cabazitaxel), you might still be able to join, depending on how you're responding to those treatments.

Basically, the study is for men whose advanced prostate cancer is being monitored or treated, and your condition needs to be stable or improving on your current treatment, or you might be just starting new treatment. If your cancer is progressing very quickly and you're feeling unwell, or if your doctor plans to start you on chemotherapy very soon, it might not be the right time for you to join this particular study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a man with prostate cancer that has spread to other parts of your body?
Is your prostate cancer still active or being treated (even if you're on medication or recent chemotherapy)?
Have scans or blood tests shown that your cancer is progressing or being actively managed?
Are you generally able to do physical activity, even if you need guidance?
Are you 18 years old or older?

Answer every question to see your result.

What does participation involve?

The detailed involvement in this study would typically include an initial assessment to confirm you're eligible and healthy enough for intense exercise. Following that, you would either be assigned to a supervised high-intensity exercise program with additional support, or to a group that continues with self-directed exercise. The supervised program would involve regular, structured exercise sessions over a period of time, likely with trainers and possibly group meetings for support. You would have regular check-ups and assessments, which could include physical tests, blood samples, and questionnaires, to monitor your health, fitness, and how the cancer is responding. The total duration of participation in the study and follow-up would be explained by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as improved physical fitness, better mood, and potentially extending your life, although this is not guaranteed for everyone. You would also receive close monitoring of your health. However, as with any exercise program, especially intense exercise, there are potential risks, such as muscle soreness, strains, or in rare cases, more serious health events. The study team will carefully assess your health before you start to make sure the exercise program is safe for you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (18)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Cedars Sinai Medical Centre
Verified postcode
Los Angeles, United States
UCSF
Verified postcode
San Francisco, United States
UC Denver
Verified postcode
Denver, United States
University of Minnesota
Verified postcode
Minneapolis, United States
Oregon Health & Science University
Verified postcode
Portland, United States
Fred Hutchinson Cancer Centre
Verified postcode
Seattle, United States
Australian Prostate Cncr Research Centre
Verified postcode
Brisbane, Australia
University of Queensland
Verified postcode
Brisbane, Australia
Victoria University / Sunshine Hospital
Verified postcode
Melbourne, Australia
Edith Cowan University
Verified postcode
Perth, Australia
University of Alberta
Verified postcode
Edmonton, Canada
Centre Hospitalier de l'Université de Montréal (CRCHUM)
Verified postcode
Montreal, Canada

Common questions

What kind of exercise is 'high-intensity'?

High-intensity exercise means activities that make your heart beat faster and make you breathe harder, like brisk power walking, jogging, cycling, or lifting weights that challenge your muscles. It will be guided by experts to ensure it's safe for you.

Will I have a choice of which group I join?

No, participants are usually assigned to either the supervised exercise group or the self-directed exercise group randomly, like flipping a coin. This helps make sure the study results are fair and unbiased.

What is 'psychosocial support'?

Psychosocial support means help with the emotional and social challenges of living with cancer. This could involve meeting with professionals or support groups to talk about your feelings, share experiences, and learn coping strategies.

Do I need to stop my current cancer treatment to join?

No, you don't need to stop your cancer treatment. In fact, many participants will be continuing with their standard treatments. The study aims to see how exercise can work alongside your existing medical care.

How long will I be in the study?

The exact duration for each person can vary, but generally, studies like this involve an active phase of structured exercise and support, followed by a period of follow-up where researchers continue to monitor your health over time.