A large clinical trial testing different combinations of hormone treatments, with or without chemotherapy called docetaxel, in men with advanced prostate cancer whose prostate-specific antigen levels haven’t dropped enough after 6 months of treatment
The INTENSIFY trial is for men with prostate cancer that has spread, where initial hormone treatment hasn't lowered a blood marker called PSA (prostate-specific antigen) below 0.2 ng/ml after about six months. Currently, these men keep taking hormone therapy. This trial wants to find out if adding chemotherapy, called docetaxel, to their existing hormone treatment sooner could help them live longer and improve their outcomes. Participants will be randomly assigned to either continue their hormone therapy or receive hormone therapy plus docetaxel chemotherapy. This study aims to provide clearer guidance for doctors on the best way to treat prostate cancer that isn't fully responding to initial hormone treatments.
At a glance
What is this study about?
When prostate cancer spreads to other parts of the body, it's called metastatic prostate cancer. While it can't be cured at this stage, it can be managed with treatments. The usual first treatment in the UK involves a combination of hormone injections and hormone tablets. To keep an eye on how well the treatment is working, doctors regularly check a blood test called PSA. Most men see their PSA level drop a lot after starting treatment.
However, sometimes, even after about six months of treatment, the PSA level doesn't fall below a certain point (0.2 ng/ml). When this happens, doctors know that the long-term outlook for these men might not be as good. The INTENSIFY study focuses on these men. Its main goal is to explore whether adding a chemotherapy drug called docetaxel to their existing hormone treatment earlier in their journey could help them live longer and healthier lives.
This study will carefully compare two groups of men: one continuing standard hormone therapy, and the other receiving hormone therapy plus docetaxel. By doing this, researchers hope to gather strong evidence to help doctors decide the best way to treat men with metastatic prostate cancer when their initial hormone treatment doesn't lower their PSA as much as hoped. This could lead to better treatment plans in the future.
Key takeaways
- The INTENSIFY study is for men with advanced prostate cancer.
- It's for those whose PSA level hasn't dropped enough after 6 months of hormone treatment.
- The study compares continuing hormone therapy with adding chemotherapy (docetaxel).
- It aims to find out if early chemotherapy helps men live longer.
- You would be randomly assigned to one of the two treatment groups.
- The study is run from Southampton Clinical Trial Unit in the UK.
Who may be eligible?
This study is looking for men who have prostate cancer that has spread to other parts of their body. You must have started hormone treatment for this condition between 5 and 8 months ago.
After about six months of this hormone treatment (which usually includes both injections and tablets), your PSA blood test result, which measures a protein related to prostate cancer, must still be 0.2 ng/ml or higher. Your PSA should never have dropped below 0.2 ng/ml since you started your hormone therapy. Also, your initial PSA before starting any hormone treatment needed to be 2 ng/ml or higher.
Overall, the study is for men whose prostate cancer isn't fully responding to their first hormone treatment as well as doctors would typically hope, based on their PSA levels.
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.
- Do I have prostate cancer that has spread to other parts of my body?
- Has my PSA level not dropped below 0.2 ng/ml after about 6 months of hormone therapy?
- Did I start my current hormone treatment for spreading prostate cancer between 5 and 8 months ago?
- Was my PSA level 2 ng/ml or higher before I started hormone treatment?
- Am I a man over 18 years old?
What does participation involve?
If you decide to join the study, you'll be randomly put into one of two groups, like flipping a coin. You won't get to choose which group you're in. One group will continue with their current hormone treatments (injections and tablets). The other group will continue their hormone treatments AND receive chemotherapy called docetaxel.
If you're in the chemotherapy group, you'll go to the hospital outpatient clinic every three weeks for up to six treatments. The docetaxel is given through a drip into your arm. Throughout the trial, you'll have regular hospital visits for blood tests and check-ups to monitor your health and how you're responding to treatment. The study is expected to run until January 2032, and your participation duration will be discussed with you.
Potential risks and benefits
Locations (1)
- -Approximate-, England
Common questions
What is PSA?
PSA stands for prostate-specific antigen. It's a protein made by the prostate gland. A blood test measures its level and can help doctors monitor prostate cancer.
What does 'metastatic' mean?
Metastatic means the cancer has spread from where it started (the prostate) to other parts of the body.
What is 'standard of care treatment'?
This refers to the usual and most accepted treatment that is currently given for your condition, based on what doctors generally agree is best.
Will I know which treatment group I'm in?
Yes, this is an 'open-label' study, meaning both you and your doctor will know whether you are receiving just hormone therapy or hormone therapy plus chemotherapy.
Who is funding this research?
The INTENSIFY trial is being funded by Prostate Cancer UK.
How to find out more
INTENSIFY Team
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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