Active not recruitingPHASE3INTERVENTIONAL

A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy

This research study, called a Phase 3 trial, is investigating a new treatment for men with high-risk prostate cancer that is still contained within the prostate or has only spread nearby. The main goal is to compare a drug called apalutamide, given alongside standard hormone therapy (ADT), with hormone therapy and a dummy drug (placebo). This treatment is given both before and after an operation to remove the prostate (radical prostatectomy) and surrounding lymph nodes. Researchers want to find out if this combined approach helps to eliminate all cancer cells in the removed prostate tissue more effectively and if it helps prevent the cancer from spreading to other parts of the body in the long term. This could potentially offer a new way to improve outcomes for men with this type of prostate cancer.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Research & Development, LLC

Enrolment target

2,517

Start

11 Jun 2019

Estimated completion

13 Oct 2028

Prostatic Neoplasms

What is this study about?

This study is a Phase 3 clinical trial, which means it's testing a potential new treatment on a larger group of people to see if it's safe and effective compared to existing treatments. The trial is focused on men with prostate cancer that is considered 'high-risk,' meaning it has certain features that suggest it might be more aggressive or likely to spread. This cancer is currently localised or locally advanced, which means it's confined to the prostate or has spread only to nearby tissues, but not to distant parts of the body.

The main idea behind this study is to see if adding a drug called apalutamide to standard hormone therapy (Androgen Deprivation Therapy, or ADT) can improve treatment outcomes. Both apalutamide and ADT work by blocking male hormones, which prostate cancer cells often need to grow. In this study, men will receive either apalutamide plus ADT or a placebo (a dummy drug) plus ADT. This pre-treatment will happen before they have surgery to remove the prostate and surrounding lymph nodes. After surgery, they will continue with their assigned treatment.

The researchers are particularly interested in two main things. Firstly, they want to see if the combination treatment leads to a higher rate of 'pathological complete response' (pCR). This means that when the prostate is removed during surgery, pathologists examine it under a microscope to see if any cancer cells are left. A pCR means no cancer cells are found, which is a very positive outcome. Secondly, they want to track how many men remain free from the cancer spreading to other parts of the body (metastasis-free survival) over time. By comparing these outcomes between the two groups, they hope to determine if apalutamide offers a significant advantage for men with high-risk prostate cancer.

Key takeaways

This study aims to improve treatment for high-risk prostate cancer that hasn't spread far.
It tests a drug called apalutamide alongside standard hormone therapy, before and after surgery.
The goal is to see if this combination shrinks cancer more effectively and prevents its spread.
Participation involves taking medication, having surgery, and regular follow-up appointments.
You might receive the new drug or a placebo, combined with standard hormone therapy.
All potential benefits and risks will be thoroughly discussed by the study team.

Who may be eligible?

This study is looking for men aged 18 or older with specific types of prostate cancer. Your cancer must be confirmed as adenocarcinoma and be considered 'high-risk.' This high-risk definition is based on several factors, including certain scores from your biopsy results (Gleason scores) and, in some cases, your PSA levels. Essentially, your cancer needs to show features that suggest it's more aggressive.

To join, doctors must also believe you are suitable for an operation to remove your prostate and nearby lymph nodes. You should generally be in good health, able to manage daily activities without much difficulty. Importantly, you cannot have had certain previous treatments for prostate cancer, such as other hormone-blocking drugs, before signing up for this study. You also cannot have cancer that has already spread to distant parts of your body. Doctors will check all these criteria carefully to ensure the study is safe and appropriate for you.

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?
Have you been diagnosed with high-risk prostate cancer that hasn't spread widely?
Are you suitable for surgery to remove your prostate and nearby lymph nodes?
Have you not previously received certain hormone-blocking treatments for prostate cancer?
Are you in generally good health and able to manage daily activities?
Are you able to take hormone therapy for at least 13 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first undergo a thorough check-up to confirm you meet all the requirements. This will involve various tests and scans. Once accepted, you will be assigned to one of two groups: either receiving apalutamide plus standard hormone therapy, or a placebo (a dummy pill) plus standard hormone therapy. Neither you nor your doctor will know which group you are in. You will take this medication before your prostatectomy operation.

After your surgery to remove the prostate and lymph nodes, you will continue with your assigned treatment for a period. Throughout the study, you will have regular clinic visits for blood tests, physical examinations, and scans to monitor your health and how the treatment is working. Doctors will carefully track your progress, including looking at the tissue removed during surgery. The total duration of your participation, including follow-up, will be determined by the study protocol, but the treatment phase before and after surgery will be closely monitored, and follow-up will continue for several years to track whether the cancer spreads.

Potential risks and benefits

Participating in any clinical trial involves potential benefits and risks. A potential benefit of this study is that you might receive a new treatment (apalutamide) that could be more effective at shrinking your cancer and preventing its spread compared to standard hormone therapy alone. However, there's no guarantee that the treatment will work for you, and it's also possible you will receive the placebo. Potential risks are associated with both the study medication and the standard treatments. Apalutamide and hormone therapy can have side effects, which will be fully explained by the study team. These might include fatigue, hot flashes, or skin rashes, among others. There are also risks associated with the surgery itself. All known risks will be discussed in detail before you decide to join. Remember, taking part is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (203)

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

UC San Diego Moores Cancer Center
Verified postcode
La Jolla, United States
University of Southern California
Verified postcode
Los Angeles, United States
Cedars Sinai Medical Center
Verified postcode
Los Angeles, United States
University of California Los Angeles
Verified postcode
Los Angeles, United States
University of California Irvine Medical Center Chao Family Comprehensive Cancer Center
Verified postcode
Orange, United States
UC Davis Medical Center
Verified postcode
Sacramento, United States
AdventHealth Medical Group Urology of Denver
Verified postcode
Denver, United States
Colorado Clinical Research
Verified postcode
Lakewood, United States
Stamford Hospital
Verified postcode
Stamford, United States
Urology Specialists LLC
Verified postcode
Hialeah, United States
Mayo Clinic - Division Of Hematology/oncology
Verified postcode
Jacksonville, United States
Miami Cancer Institute at Baptist Health / Baptist Health Medical Group
Verified postcode
Miami, United States

Common questions

What is 'high-risk localised or locally advanced prostate cancer'?

This means the cancer has certain features, like specific biopsy results, indicating it might be more aggressive, but it hasn't spread to distant parts of your body yet.

What is apalutamide?

Apalutamide is a drug designed to block the effects of male hormones that can fuel prostate cancer growth, working in a similar way to, but potentially in addition to, standard hormone therapy.

What is a 'placebo'?

A placebo is an inactive substance that looks just like the real study drug but contains no active medicine. It helps researchers compare the effects of the active drug accurately.

What does 'radical prostatectomy' mean?

This is a surgical operation to remove the entire prostate gland and sometimes nearby tissues, like lymph nodes, to treat prostate cancer.

Will I know if I'm getting the active drug or the placebo?

No, this is a 'blinded' study, meaning neither you nor your doctors will know if you're receiving apalutamide or the placebo. This ensures the results are unbiased.