An open label, single-arm, phase 2 study of neoadjuvant PEMbrolizumab before radical PROstatectomy (PEM-PRO) in high-risk prostate cancer patients
This study, called PEM-PRO, is investigating a new treatment for men with high-risk prostate cancer. Currently, men with this type of cancer often have surgery to remove their prostate. This study wants to see if giving a medicine called Pembrolizumab (also known as Keytruda) before surgery can help improve their results. Pembrolizumab is an immunotherapy drug that helps your body's own immune system fight cancer. The main goal is to see if this treatment can reduce the chance of cancer spreading to the lymph nodes, which are small glands that are part of your immune system. Researchers hope that giving this drug first might lead to fewer men having cancer in their lymph nodes when they have their operation.
At a glance
What is this study about?
This research study, known as PEM-PRO, is focusing on men who have a type of prostate cancer considered 'high-risk.' This means the cancer might be more aggressive or has a higher chance of spreading. Currently, for many men with high-risk prostate cancer, the main treatment involves surgery to remove the prostate gland. This study is exploring a new approach: giving a specific medicine before that surgery.
The medicine being tested is called Pembrolizumab, which you might also know by its brand name, Keytruda. Keytruda is a type of 'immunotherapy' drug. This means it works by helping your own body's immune system recognise and fight the cancer cells. The doctors want to find out if giving Keytruda before the prostate surgery can make a difference to the treatment outcome. They are particularly interested in whether it can reduce the number of men who have cancer cells in their lymph nodes at the time of surgery. Detecting cancer in lymph nodes is important for predicting how the cancer might behave and guiding future treatment decisions.
The main aim of this study is to see if this new approach can lead to better results compared to what doctors currently see. Specifically, they are hoping to reduce the rate of cancer spreading to the lymph nodes by a significant amount. If successful, this could mean better long-term health outcomes for men with high-risk prostate cancer by making the surgery more effective and potentially reducing the need for further treatments later on.
Key takeaways
- This study is for men with high-risk prostate cancer.
- It tests a drug called Pembrolizumab (Keytruda) before prostate surgery.
- The main goal is to reduce cancer spread to lymph nodes.
- It's a Phase II study, meaning it's exploring how well the treatment works.
- Participation involves infusions, special scans, and follow-up appointments.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for men aged 18 or older to take part. There isn't an upper age limit, meaning older men are also welcome to join if they meet other criteria.
To be considered for this study, you must have been diagnosed with high-risk prostate cancer. This is a specific category of prostate cancer that doctors identify based on various tests like PSA levels, biopsy results, and scans. You would typically be someone who is already scheduled to have surgery to remove your prostate gland (a 'radical prostatectomy').
There will also be other health requirements and tests to make sure that taking part in the study would be safe for you. Your doctor will be able to check all of these details with you.
- Are you a man?
- Are you 18 years old or older?
- Have you been diagnosed with high-risk prostate cancer?
- Are you planning to have surgery to remove your prostate (radical prostatectomy)?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive the study medication, Pembrolizumab (Keytruda), as an infusion. An infusion means the medicine is given slowly into your vein, similar to a drip. You would receive this treatment in cycles before you have your planned prostate surgery. The study also involves a special type of scan called a [68GA]PSMA-HBED-CC scan. This scan uses a small amount of a radioactive substance to help doctors see the prostate cancer more clearly and to check for spread.
Throughout the study, you would have regular appointments, including physical examinations, blood tests, and potentially other scans or assessments, to monitor your health and how you are responding to the treatment. After your surgery, doctors would continue to follow up on your health and recovery for a period of time to understand the long-term effects of the treatment. The total duration of your active participation, including treatment and follow-up, would be fully explained by the study team.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What is 'high-risk prostate cancer'?
High-risk prostate cancer means the cancer is considered more aggressive or has a higher chance of spreading, based on specific medical tests.
What is Pembrolizumab (Keytruda)?
Pembrolizumab, or Keytruda, is a type of drug called immunotherapy. It helps your body's own immune system fight the cancer cells.
Why is this treatment given before surgery?
Doctors are trying to see if giving this drug before surgery can shrink the cancer or stop it from spreading to lymph nodes, potentially leading to better outcomes from the surgery.
What is a [68GA]PSMA-HBED-CC scan?
This is a special scan that helps doctors get a very clear picture of your prostate cancer and check if it has spread to other parts of your body, like lymph nodes.
Will I still have my prostate removed?
Yes, this study involves giving you medication before your planned surgery to remove your prostate (radical prostatectomy).
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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