Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A feasibility trial investigating inductive Apalutamide therapy combined with radical prostatectomy in patients with locally advanced T4 high risk prostate cancer

This research is a Phase II study for men diagnosed with an aggressive type of prostate cancer that is still contained within the prostate area. The main goal is to explore whether a new medication, JNJ-56021927, given for up to six months before surgery, can help shrink the cancer. Doctors will use scans and exams to check if the tumour becomes small enough for surgery. If the cancer hasn't shrunk enough after six months, treatment might be extended. The study also looks at how complete the cancer removal is during surgery, how many men have clear margins, and their quality of life. This helps doctors learn if this new approach could improve outcomes for patients needing prostate cancer treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitaet Des Saarlandes

Enrolment target

Start

18 Jan 2024

Patients with locally advanced T4 high risk prostate cancer

What is this study about?

This study is a Phase II clinical trial, which means it's one of the earlier steps in testing a new treatment. It's designed for men who have a type of prostate cancer that is considered 'high-risk' and 'locally advanced'. This means the cancer is aggressive and has grown within the prostate or slightly beyond its capsule, but it hasn't spread to distant parts of the body. The main idea behind this trial is to see if giving a specific drug, called JNJ-56021927, before surgery (this is called 'inductive therapy') can make the surgery more effective.

The researchers want to find out if this pre-surgery treatment can shrink the cancer enough to make it easier and safer to remove with surgery. They will carefully assess patients using MRI scans, ultrasound, and physical examinations by experienced surgeons to decide if the prostate can be successfully removed after the treatment. This initial treatment period could last up to six months, and if the cancer hasn't responded enough by then, the treatment might be extended for a bit longer.

Beyond just seeing if surgery becomes possible, the study will also look at lots of other important things. This includes how completely the cancer is removed during surgery, whether there are any cancer cells left at the edges of the removed tissue (called 'margins'), and if the men have a full recovery biochemically (meaning no detectable PSA in their blood) after surgery. The study also considers the patients' quality of life throughout the process, using questionnaires to understand how they are feeling.

Key takeaways

A study testing a new drug (JNJ-56021927) for aggressive prostate cancer.
The drug is given before surgery to try and shrink the cancer.
Aims to make surgery more successful and remove the cancer completely.
Close monitoring with scans and exams will be part of the trial.
Also looking at patient quality of life during treatment.

Who may be eligible?

To be considered for this study, you must be a man aged 18 or older. You need to have been diagnosed with a specific type of high-risk prostate cancer that is considered locally advanced, meaning it has grown within the prostate or slightly outside it, but has not spread to other parts of your body. Doctors will use medical imaging like MRI and ultrasound to confirm this type of cancer.

There will be other detailed medical criteria that your specialist will check to make sure the study treatment is safe and appropriate for your specific health situation. For instance, they will review your general health, other medical conditions you might have, and any previous treatments.

Essentially, the study is looking for men with a particular stage of aggressive prostate cancer who are otherwise well enough to potentially undergo surgery after the investigational treatment.

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.

Are you a man, aged 18 or older?
Do you have high-risk, locally advanced prostate cancer?
Has your cancer not spread to other parts of your body?
Are you generally well enough to undergo treatment and potentially surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study drug, JNJ-56021927, for up to six months before planned surgery to remove your prostate. Throughout this period, you would have regular appointments, including MRI scans, transrectal ultrasound, and physical examinations with two experienced surgeons. These assessments help doctors track how the cancer is responding to the treatment and determine if surgery is suitable. If your cancer hasn't responded enough after six months, your treatment might be extended for a short time.

After your prostatectomy (surgery), you would continue to have follow-up visits. These visits would include blood tests to check your PSA levels, to see if the cancer is completely gone, and to monitor for any complications. You would also complete questionnaires to assess your quality of life. The total duration of your participation, including follow-up, would be determined by several factors, including your treatment response and recovery.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as gaining access to a new treatment before it's widely available, which might improve your chances of successful surgery. You would also receive very close medical monitoring throughout the study. However, there are also potential risks; the new drug might cause side effects, and it's not guaranteed to work for everyone. There could also be risks associated with the surgery itself, as with any major operation. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What type of prostate cancer is this study for?

This study is for men with high-risk, locally advanced prostate cancer, meaning it's aggressive and has grown but hasn't spread to distant parts of the body.

What is JNJ-56021927?

JNJ-56021927 is a new drug being tested to see if it can shrink prostate cancer before surgery.

What does 'inductive therapy' mean?

Inductive therapy means you receive treatment with the study drug before undergoing surgery to remove your prostate.

Will I still have surgery if I join this study?

The aim of the study is to see if the pre-surgery treatment makes you eligible for surgery, which would then be planned.

How long will the pre-surgery treatment last?

The pre-surgery treatment with the drug could last up to six months, and potentially a bit longer if needed.