Active not recruitingPHASE3INTERVENTIONAL

A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer

This research study is for men with specific types of prostate cancer that has a high chance of spreading, even if it hasn't spread yet. Doctors are trying to find out if adding a new drug, apalutamide, to the usual treatment of radiotherapy and hormone therapy (LHRH agonist) can be more effective. The main goal is to see if this combination can stop the cancer from spreading for a longer time, or prolong life, compared to just having radiotherapy and hormone therapy. Participants will be carefully monitored, and the study will help us understand if this new treatment approach is better for certain high-risk prostate cancers.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Janssen Pharmaceutica N.V., Belgium

Enrolment target

692

Start

12 Nov 2020

Estimated completion

15 Sep 2031

Prostatic Neoplasms

What is this study about?

This study is investigating a new way to treat prostate cancer, specifically for men whose cancer has a high risk of spreading, even if it hasn't spread to other parts of the body yet. The usual treatments for this kind of prostate cancer often include radiotherapy (using radiation to kill cancer cells) and hormone therapy (which lowers the male hormones that can make prostate cancer grow). This research aims to see if adding an extra drug, called apalutamide, to this standard combination can improve outcomes.

Apalutamide is a drug that works by blocking the male hormones that can fuel prostate cancer growth. By adding it to the existing treatments, doctors hope to achieve a stronger effect against the cancer cells. The main goal is to find out if this triple treatment can prevent the cancer from spreading (this is called 'metastatic progression') for a longer period, or if it can help men live longer, compared to only receiving radiotherapy and hormone therapy.

To figure this out, some men in the study will get the standard treatment, while others will get the standard treatment plus apalutamide. Researchers will then compare how both groups fare over time. This kind of study helps doctors understand if new treatments are safe and more effective than current ones, ultimately improving care for people with prostate cancer.

Key takeaways

Tests a new drug (apalutamide) for high-risk prostate cancer.
Compares apalutamide plus standard treatment to standard treatment alone.
Aims to prevent cancer spreading and improve survival.
Focuses on men with prostate cancer previously treated with surgery.
Involves taking tablets and having regular check-ups and scans.

Who may be eligible?

This study is for men who have been diagnosed with a specific type of prostate cancer that has a high chance of coming back or spreading, even after previous surgery. You might be eligible if you've had surgery to remove your prostate, and either your PSA levels (a marker for prostate cancer) started low and then went up, or they never went down enough after surgery.

To join, doctors will need to confirm your prostate cancer diagnosis from a tissue sample. You also need to be able to swallow tablets or mix them with applesauce, as this is how the study drug is taken. You'll also have special scans (called PSMA-PET scans) to check the prostate cancer and make sure it hasn't spread widely at the beginning of the study.

Overall, the study is looking for men whose prostate cancer is considered 'high-risk' because of things like the type of cancer cells found in their initial surgery, or how quickly their PSA levels have changed. Doctors will review all your medical information to see if this study is suitable 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.

Have you been diagnosed with prostate cancer?
Have you had surgery (radical prostatectomy) for your prostate cancer?
Has your doctor told you your prostate cancer is considered 'high-risk'?
Are you able to swallow tablets or mix them with applesauce?
Are you male and over 18 years old?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to one of two groups. One group will receive the standard treatment which includes radiotherapy (radiation therapy) and a hormone therapy drug (LHRHa). The other group will receive the same standard treatment but will also take the study drug, apalutamide, in tablet form. You'll need to be able to swallow these tablets whole or follow instructions to mix them with applesauce.

Throughout the study, 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 assessments, such as PSMA-PET scans, will help doctors track the cancer's response. The total time you'd be involved in the study, including treatment and follow-up, would be determined by the study plan, and doctors will explain this in detail. Regular follow-up will be crucial to understand the long-term effects of the treatment.

Potential risks and benefits

Taking part in any study has potential benefits and risks. Potential benefits could include receiving cutting-edge treatment that might be more effective than current options, and contributing to medical knowledge that helps future patients. However, there are potential side effects from all medications and treatments used in this study, which your doctor will explain fully. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (141)

Arizona Urology Specialists
Verified postcode
Tucson, United States
Arkansas Urology
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Little Rock, United States
Colorado Clinical Research
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Lakewood, United States
Urological Research Network
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Hialeah, United States
First Urology, PSC
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Jeffersonville, United States
Michigan Institute of Urology
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Troy, United States
Associated Medical Professionals of Ny
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Syracuse, United States
The Urology Group
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Cincinnati, United States
Oregon Urology Institute
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Springfield, United States
MidLantic Urology
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Bala-Cynwyd, United States
Urology Austin
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Austin, United States
Houston Metro Urology
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Houston, United States

Common questions

What is 'hormone-sensitive prostate cancer'?

This means your prostate cancer is still responding to treatments that lower male hormones in your body.

What is apalutamide and how does it work?

Apalutamide is a medication that blocks the effects of male hormones, which can help stop prostate cancer cells from growing.

What does 'high-risk' prostate cancer mean?

It means your cancer has certain features that suggest it has a higher chance of spreading in the future, even if it hasn't yet.

What is a 'PSMA-PET scan'?

It's a special type of scan that helps doctors find prostate cancer cells more accurately in the body.

Will I know if I'm getting apalutamide or not?

In this type of study, participants usually don't know which treatment group they are in. This helps ensure fair results.