جميع الدراسات
نشط غير مجندالمرحلة 3تدخلي

Phase 3 Study of Xaluritamig vs Cabazitaxel or Second Androgen Receptor-Directed Therapy in Participants With Progressive Metastatic Castration-Resistant Prostate Cancer (XALute)

This study, named XALute, is for men with advanced prostate cancer that continues to grow despite standard hormone treatment (metastatic castration-resistant prostate cancer). It is testing a new drug, Xaluritamig, against current commonly used treatments such as Cabazitaxel or other hormone-based medicines (like Abiraterone or Enzalutamide). The main goal is to see if Xaluritamig can help men live longer compared to these existing options. Participants will be carefully monitored throughout the study. This research aims to find better ways to manage this type of prostate cancer and improve patients' lives. Researchers will compare how well Xaluritamig works against the doctor's choice of standard treatment.

نظرة سريعة

الحالة
نشط غير مجند
المرحلة
المرحلة 3
الراعي
Amgen
الهدف من التسجيل
707
ابدأ
09 ديسمبر 2024
التاريخ المتوقع للانتهاء
30 يوليو 2029

ما هو موضوع هذه الدراسة؟

This clinical trial is investigating a new treatment called Xaluritamig for men diagnosed with advanced prostate cancer. This specific type of cancer is called 'metastatic castration-resistant prostate cancer,' which means the cancer has spread to other parts of the body (metastatic) and is still growing even after hormone treatment to lower testosterone (castration-resistant).

The main purpose of this study is to compare Xaluritamig with treatments that doctors already use, such as Cabazitaxel or a second type of hormone therapy (like Abiraterone or Enzalutamide). The researchers want to find out if Xaluritamig is better at helping men live longer than these standard options. By conducting this research, doctors hope to discover more effective ways to treat this challenging form of prostate cancer.

Participation in this study could offer access to a new experimental treatment. However, it's important to remember that this is a research study, and we don't yet know if Xaluritamig will be more effective or safer than current treatments. All participants will be closely monitored by a medical team throughout the trial to ensure their safety and track their progress.

النقاط الرئيسية

  • Tests a new medicine, Xaluritamig, for advanced prostate cancer.
  • Compares Xaluritamig to existing standard treatments.
  • Aims to see if Xaluritamig helps men live longer.
  • For men whose prostate cancer has spread and is resistant to hormone treatment.
  • Requires previous treatment with at least one hormone therapy and one chemotherapy.

من قد يكون مؤهلاً؟

This study is looking for men aged 18 or older who have advanced prostate cancer that has spread and is no longer responding to initial hormone treatments. Your doctor must have confirmed your prostate cancer as adenocarcinoma, and it cannot be mixed with other types of cancer.

You must have signs of the cancer getting worse, which could be seen in your blood tests (like PSA levels), scans (like CT, MRI, or bone scans showing new or growing spots), or both. You must have already had surgery to remove your testicles or be receiving ongoing hormone therapy to keep your testosterone levels very low. You also need to have tried at least one hormone-blocking medicine before (like enzalutamide or abiraterone) and had one type of chemotherapy (taxane medicine) for your advanced prostate cancer.

Your general health and ability to perform daily activities need to be good, as assessed by a doctor. Specific types of earlier treatments might affect whether you can join, so your medical history will be carefully reviewed.

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.

  1. هل عمرك 18 سنة أو أكثر؟
  2. Do you have advanced prostate cancer that has spread and kept growing despite hormone treatment?
  3. Have you already had at least one hormone-blocking medicine and one chemotherapy for your advanced prostate cancer?
  4. هل صحتك العامة جيدة بما يكفي لتتمكن من إدارة الأنشطة اليومية؟
  5. Do your scans and blood tests show that your cancer is currently getting worse?
أجب عن كل سؤال لترى نتيجتك.

ماذا يتضمن المشاركة؟

If you decide to take part, you will be assigned to receive either the new medicine, Xaluritamig, or one of the standard treatments (Cabazitaxel or another hormone-based medicine chosen by your doctor). You will have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. These tests will help the doctors keep track of your cancer and any side effects you might experience.

The specific schedule for visits and tests will depend on the treatment you receive, but you can expect frequent monitoring throughout the study. The total duration of your participation will vary depending on how you respond to the treatment and the study's requirements. You will receive the study medication as directed by the research team. After treatment, there will likely be follow-up appointments to continue monitoring your long-term health and the effects of the treatment.

المخاطر والفوائد المحتملة

Taking part in this study could potentially offer you access to a new treatment that might be more effective than current options, though this is not guaranteed. All medicines can have side effects, and Xaluritamig is still being investigated, so its full range of risks isn't fully known yet. You will be closely monitored for any side effects, and the medical team will provide care and support. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (164)

  • جامعة ألاباما في برمنغهام
    الرمز البريدي المؤكد
    برمنغهام، الولايات المتحدة
  • مركز مدينة الأمل الطبي الوطني
    الرمز البريدي المؤكد
    دوارتي، الولايات المتحدة
  • Providence Saint Jude Medical Center
    الرمز البريدي المؤكد
    فوليرتون، الولايات المتحدة
  • مركز سيدرز سيناي الطبي
    الرمز البريدي المؤكد
    لوس أنجلوس، الولايات المتحدة
  • جامعة كاليفورنيا إيرفين
    الرمز البريدي المؤكد
    أورانج، الولايات المتحدة
  • جامعة كاليفورنيا سان فرانسيسكو
    الرمز البريدي المؤكد
    سان فرانسيسكو، الولايات المتحدة
  • University of Florida, College of Medicine
    الرمز البريدي المؤكد
    غينزفيل، الولايات المتحدة
  • Sylvester Comprehensive Cancer Center-Fox Building
    الرمز البريدي المؤكد
    ميامي، الولايات المتحدة
  • AdventHealth Orlando
    الرمز البريدي المؤكد
    أورلاندو، الولايات المتحدة
  • جامعة شيكاغو
    الرمز البريدي المؤكد
    شيكاغو، الولايات المتحدة
  • جامعة إنديانا
    الرمز البريدي المؤكد
    إنديانابوليس، الولايات المتحدة
  • University of Louisville Health - James Graham Brown Cancer Center
    الرمز البريدي المؤكد
    لويفيل، الولايات المتحدة

أسئلة شائعة

ما هو 'سرطان البروستاتا المقاوم للإخصاء النقيلي'؟

This means your prostate cancer has spread to other parts of your body (metastatic) and is still growing even though you're receiving hormone treatment to lower your testosterone (castration-resistant).

What is Xaluritamig?

Xaluritamig is a new experimental drug being tested in this study. We are trying to find out if it is a better treatment option for this type of prostate cancer.

What kinds of treatments will Xaluritamig be compared to?

It will be compared to existing treatments like Cabazitaxel (a chemotherapy) or a second type of hormone therapy such as Abiraterone or Enzalutamide.

هل سأعرف أي علاج أتلقى؟

Yes, in this study, you will know if you are receiving Xaluritamig or one of the standard treatments chosen by your doctor.

ما هو الهدف الرئيسي من الدراسة؟

The main goal is to see if Xaluritamig helps men with this type of prostate cancer live longer compared to men receiving the standard treatments.

كيفية معرفة المزيد

تحدث دائمًا إلى طبيبك العام أو الأخصائي قبل اتخاذ قرار بالمشاركة في دراسة.

نقاش

مناقشة المجتمع

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