Evaluation of Neoadjuvant Xaluritamig in Localized Prostate Cancer
This study explores a new medicine called xaluritamig for men with prostate cancer that is contained within the prostate gland and has not spread elsewhere. The main goals are to check if xaluritamig is safe and well-tolerated when given before a surgery called a radical prostatectomy. We are investigating xaluritamig both on its own and in combination with another type of prostate cancer drug called a GnRH antagonist. We also want to understand if it's feasible and safe to perform the radical prostatectomy after patients have received xaluritamig treatment. This combination approach, giving medicine before surgery, is known as 'neoadjuvant therapy' and aims to shrink the tumour or make surgery more effective.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
This research is focused on men who have prostate cancer that is still contained within the prostate gland and hasn't spread to other parts of the body. This type of treatment, where medicine is given before surgery, is called 'neoadjuvant therapy'. The idea behind it is that by giving medicine first, we might be able to shrink the cancer, making the surgery easier or more effective, or even reducing the chances of the cancer coming back.
The main aim of this study is to look at a new drug called xaluritamig. We want to find out if it's safe for men to take before they have an operation to remove their prostate (called a radical prostatectomy). We're testing xaluritamig in two ways: some men will receive it on its own, and others will get it alongside another common prostate cancer medicine called a GnRH antagonist. GnRH antagonists are already used to lower hormone levels that can feed prostate cancer.
Another important part of this study is to see if having a radical prostatectomy is still safe and goes well after someone has taken xaluritamig. By carefully checking the side effects and how patients recover, we can learn more about how this new treatment approach might help men with prostate cancer in the future.
النقاط الرئيسية
- This study tests a new drug (xaluritamig) for prostate cancer that hasn't spread.
- The treatment is given before prostate surgery (radical prostatectomy).
- It aims to see if xaluritamig is safe and improves surgery outcomes.
- Participants may receive xaluritamig alone or with another common prostate cancer medicine.
- Regular hospital visits and checks are part of taking part.
من قد يكون مؤهلاً؟
This study is for men who have prostate cancer that hasn't spread beyond the prostate or nearby lymph nodes, and who are planning to have surgery to remove their prostate. Your doctors will need to confirm you have prostate cancer based on a biopsy, and it should be an 'intermediate-' or 'high-risk' type, which they will explain to you.
To be considered, you'll need to have had specific scans recently, like a PSMA-PET scan, to help determine the extent of your cancer. Your general health and ability to carry out daily activities will also be assessed, usually by a simple performance score.
You won't be able to join if you've already had treatment for your prostate cancer (though there might be a small exception if you've recently had a specific type of hormone therapy). Also, if your cancer has spread to other parts of your body, or if you have certain other serious health conditions like an active infection or an autoimmune disease that permanently affects your immune system, you won't be able to take part.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- Are you a man with prostate cancer?
- Is your prostate cancer considered 'intermediate-' or 'high-risk'?
- Are you planning to have surgery to remove your prostate?
- Has your prostate cancer not spread beyond the prostate or nearby lymph nodes?
- Have you not received previous treatment for your prostate cancer (with some exceptions)?
ماذا يتضمن المشاركة؟
If you decide to take part in this study, you will receive either xaluritamig on its own or xaluritamig combined with a GnRH antagonist, before your planned prostatectomy surgery. The study involves regular visits to the hospital for checks, which may include physical exams, blood tests, and scans. These visits will monitor how you are responding to the medication and check for any side effects. After your surgery, you will continue to have follow-up appointments to monitor your recovery and the long-term effects of the treatment. The total duration of your participation, including the treatment period and follow-up, will be explained in detail by the study team, but typically involves several months of treatment followed by ongoing checks.
المخاطر والفوائد المحتملة
المواقع (9)
- جامعة كاليفورنيا سان فرانسيسكوالرمز البريدي المؤكدسان فرانسيسكو، الولايات المتحدة· التوظيف
- Washington Universityالرمز البريدي المؤكدسانت لويس، الولايات المتحدة· التوظيف
- جامعة ولاية أوهايوالرمز البريدي المؤكدكولومبوس، الولايات المتحدة· التوظيف
- جامعة توماس جيفرسونالرمز البريدي المؤكدفيلادلفيا، الولايات المتحدة· التوظيف
- مركز كارولينا لأبحاث المسالك البوليةالرمز البريدي المؤكدميرتل بيتش، الولايات المتحدة· التوظيف
- Fred Hutchinson Cancer Centerالرمز البريدي المؤكدسياتل، الولايات المتحدة· التوظيف
- Medical College of Wisconsinالرمز البريدي المؤكدميلووكي، الولايات المتحدة· التوظيف
- مستشفى جامعة إيسنالرمز البريدي المؤكدإيسن، ألمانيا· التوظيف
- Universitaetsklinikum Hamburg Eppendorfالرمز البريدي المؤكدهامبورغ، ألمانيا· التوظيف
أسئلة شائعة
ماذا يعني مصطلح 'العلاج المساعد الجديد'؟
Neoadjuvant means giving treatment, like medication, before the main treatment, which in this case is surgery. The goal is often to shrink the cancer or make surgery more effective.
What is xaluritamig?
Xaluritamig is the new medicine being tested in this study for prostate cancer. It's not yet approved for general use, so we are studying its effects.
What is a GnRH antagonist?
A GnRH antagonist is a type of hormone medicine often used for prostate cancer to lower the levels of hormones that can make the cancer grow.
Will I still need surgery if I join this study?
Yes, this study involves taking medication *before* you have your planned surgery to remove the prostate (radical prostatectomy).
What kind of prostate cancer is this study for?
This study is for men with prostate cancer that is contained within the prostate or nearby lymph nodes and hasn't spread further. It's typically for 'intermediate-' or 'high-risk' prostate cancer.
كيفية معرفة المزيد
Amgen Call Center
تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.
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نقاش
مناقشة المجتمع
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