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RecruitingPHASE3INTERVENTIONAL

A Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer

This research study is for men with advanced prostate cancer that has spread to other parts of the body and is no longer responding to treatments that lower male hormones (doctors call this metastatic castration-resistant prostate cancer). The main goal is to find out if combining a new medicine called pasritamig with a standard chemotherapy drug, docetaxel, can keep the cancer from growing for a longer time, compared to using docetaxel by itself. This is measured by looking at scans. We want to see if this new combination offers a better way to manage the cancer and improve patient outcomes.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Janssen Research & Development, LLC
Enrolment target
800
Start
19 Dec 2025
Estimated completion
20 Jul 2029

What is this study about?

This study is looking into a new treatment approach for men with a type of prostate cancer that has spread (metastatic) and has become resistant to standard hormone-lowering therapies. This is often called metastatic castration-resistant prostate cancer, or mCRPC. For these men, the cancer continues to grow even when male hormone levels are kept very low. The study aims to see if adding an investigational drug called pasritamig to a well-known chemotherapy drug, docetaxel, can be more effective than docetaxel alone.

The main thing researchers want to find out is if the combination of pasritamig and docetaxel can allow men to live longer without their cancer getting worse (this is called radiographic progression-free survival, meaning doctors check scans to see if the cancer is growing). If the combination treatment can delay the cancer's progression, it could offer a new and better option for managing this advanced form of prostate cancer.

Understanding how different treatments work is crucial for improving care. By comparing the new combination with an existing treatment, doctors can learn more about the best ways to help patients. This study is an important step in that process, with the potential to provide valuable information that could benefit future patients.

Key takeaways

  • This study is for men with advanced, hormone-resistant prostate cancer that has spread.
  • It tests a new drug (pasritamig) combined with regular chemotherapy (docetaxel) against docetaxel alone.
  • The main goal is to see if the new combination can stop the cancer from growing for longer.
  • Participation involves regular clinic visits, tests, and scans to monitor your health.
  • You will be given either the new combination or the standard chemotherapy treatment.
  • You can stop participating in the study at any time.

Who may be eligible?

To be part of this study, you would need to be a man with prostate cancer that has spread, and your doctor must have confirmed this under a microscope. Your cancer should also be a type that has become resistant to hormone treatments, even though your male hormone levels are kept low, either by ongoing injections or if you've had surgery to remove your testicles. You will have already tried at least one other type of hormone therapy that targets the androgen receptor pathway, but no more than two, and you must have stopped taking it before joining the study.

There are also reasons why you might not be able to join. For example, if your prostate cancer has spread to your brain or the lining around your brain. Also, if you have certain genetic changes in the BRCA1 or BRCA2 genes, you might not be able to join unless you've already had a specific type of treatment (called a PARP inhibitor) or can't take it for medical reasons. If you've had another cancer that could affect how the study is measured, or if you've already had chemotherapy for your prostate cancer, you would likely not be able to participate. You also shouldn't have previously received treatments that specifically target human kallikrein 2 (KLK-2).

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.

  1. Do you have prostate cancer that has spread and is no longer responding to hormone therapy?
  2. Are you currently on hormone-lowering treatment (or have you had a bilateral orchiectomy)?
  3. Have you tried at least one, but no more than two, other hormone-related therapies for your prostate cancer that you've now stopped?
  4. Have you not received chemotherapy for your prostate cancer before?
  5. Do you have good general health and are able to carry out most daily activities?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the investigational drug pasritamig along with docetaxel and prednisone, or docetaxel and prednisone alone. The study involves regular visits to the clinic for treatments, medical checks, blood tests, and scans to monitor your health and how the treatment is affecting your cancer. These scans will help doctors see if your cancer is growing or staying stable. The duration of your participation will depend on how you respond to the treatment, or until your doctors decide it's no longer the best option for you. You will also have follow-up appointments after your treatment period ends.

Potential risks and benefits

Participating in a study like this might offer a potential benefit of accessing a new treatment combination that could be more effective than current standard options for your type of prostate cancer. However, there are also potential risks, as with any medical treatment. These could include side effects from the study drugs, which will be carefully monitored. The research team will explain all known side effects. It's important to remember that you can decide to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (117)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Arizona Clinical Trials
    Verified postcode
    Chandler, United States· Recruiting
  • Arkansas Urology
    Verified postcode
    Little Rock, United States· Recruiting
  • University Of California San Diego
    Verified postcode
    La Jolla, United States· Recruiting
  • USC Norris Comprehensive Cancer Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • Valkyrie Clinical Trials
    Verified postcode
    Los Angeles, United States· Recruiting
  • Kaiser Permanente Southern California
    Verified postcode
    Riverside, United States· Recruiting
  • Sharp Center for Research
    Verified postcode
    San Diego, United States· Recruiting
  • Providence Saint John s Health Center
    Verified postcode
    Santa Monica, United States· Recruiting
  • Rocky Mountain Cancer Centers
    Verified postcode
    Aurora, United States· Recruiting
  • Grand Valley Oncology
    Verified postcode
    Grand Junction, United States· Recruiting
  • Colorado Clinical Research
    Verified postcode
    Lakewood, United States· Recruiting
  • Florida Cancer Specialists
    Verified postcode
    Sarasota, United States· Recruiting

Common questions

What is prostate cancer?

Prostate cancer is a type of cancer that begins in the prostate gland, a small gland in men that helps produce semen.

What does 'metastatic castration-resistant' mean?

This means your prostate cancer has spread to other parts of your body (metastatic) and is still growing even though treatments have lowered your male hormone levels (castration-resistant).

What are docetaxel and prednisone?

Docetaxel is a chemotherapy drug commonly used for prostate cancer, and prednisone is a steroid medication often given with chemotherapy.

What is pasritamig?

Pasritamig is an investigational drug, meaning it's still being studied to see how safe and effective it is.

Will I know which treatment I'm getting?

In this type of study, participants are usually assigned to one group or another by chance, and sometimes neither you nor your doctor will know which treatment you are receiving until the end of the study. This helps ensure fair results.

How to find out more

Study Contact

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of Pasritamig With Docetaxel Versus Docetaxel in Par…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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