Active not recruitingPHASE3INTERVENTIONAL

A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

This study is investigating a new treatment for men whose prostate cancer has returned after initial treatments like surgery or radiotherapy, shown by rising PSA levels. Even if regular scans don't show the cancer, a special scan (PSMA PET/CT) might pick it up. The study combines darolutamide, a drug that blocks male hormones, with standard hormone therapy (ADT). Male hormones can make prostate cancer grow, so blocking them helps. Researchers want to find out if this new combination helps men live longer without their cancer spreading or getting worse, compared to hormone therapy alone. Participants will take either darolutamide or a dummy pill, alongside hormone therapy, for two years, and will be monitored closely.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Bayer

Enrolment target

985

Start

03 Apr 2023

Estimated completion

29 Mar 2030

Biochemically Recurrent Prostate Cancer

What is this study about?

Imagine you've had treatment for prostate cancer, like surgery or radiotherapy, and everything seemed fine. But then, a blood test for a specific protein called PSA (Prostate Specific Antigen) shows that its levels are going up again. This can mean the cancer is trying to come back, even if regular scans don't show it yet. This is what doctors call 'biochemical recurrence' of prostate cancer.

Having your PSA levels rise means there's a higher chance the cancer could spread to other parts of your body, which then makes it harder to treat. That's why researchers are looking for better ways to catch and treat it early. In this study, they're using a special, more sensitive scan called a PSMA PET/CT scan, which can find tiny spots of cancer that regular scans might miss. This helps them understand if the new treatment is working effectively.

Prostate cancer often relies on male hormones, like testosterone, to grow. Standard treatment called 'androgen deprivation therapy' (ADT) works by lowering these hormone levels. This study is testing if adding a new drug called darolutamide, which blocks these hormones even more effectively at the cancer cell level, can improve the outcome when given alongside standard ADT. The goal is to see if this combination can keep the cancer from spreading and help you live longer without the cancer getting worse.

Key takeaways

This study investigates a new combination treatment for prostate cancer that has returned.
It aims to stop the cancer from spreading to other parts of the body.
You would receive either a new drug (darolutamide) or a dummy pill, both with standard hormone therapy.
The treatment part lasts about two years, with extensive monitoring and follow-up.
Special scans will be used to track the cancer's progress more accurately.

Who may be eligible?

This study is looking for men aged 18 or older who have prostate cancer.

You might be able to join if your prostate cancer was recently treated with surgery or radiotherapy, but its PSA levels have started to rise again, suggesting the cancer has come back. For special scans (PSMA PET/CT) to show at least one small spot of cancer. Your PSA levels also need to be at a certain level and rising fairly quickly. Your general health should be good enough for you to take part, and you shouldn't have any other serious medical conditions that would make taking the study drugs unsafe.

Quick self-check

Are you a man aged 18 or older?
Has your prostate cancer come back, shown by rising PSA levels after previous treatment?
Has a special PSMA PET/CT scan confirmed at least one cancer spot?
Is your general health good enough for you to take part?
Are you able to take tablets twice a day?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll first have a screening phase where various tests will be done to make sure you're suitable for the study. If you qualify, you'll be randomly assigned (like drawing names from a hat) to one of two groups: one group will receive darolutamide plus standard hormone therapy (ADT), and the other group will receive a dummy pill (placebo) plus standard hormone therapy (ADT). You'll take these tablets twice a day by mouth.

The treatment part of the study is planned to last for 24 months (two years). During this time, you'll have regular visits where the study team will do things like take blood and urine samples, measure your PSA and testosterone levels, perform physical exams, check your heart with an ECG, and monitor your general health and vital signs. You'll also have various scans, including the special PSMA PET/CT scans, along with CT, MRI, and bone scans, to check on your cancer. If needed, a small sample of your tumour might be taken. You'll also be asked about any medical problems you experience.

After your treatment finishes, or if you need to stop treatment early, the study team will continue to check on your health and cancer status for an extended period. This follow-up will continue until the end of the study or if you leave for any reason.

Potential risks and benefits

By taking part in this study, you might benefit from receiving a new treatment (darolutamide) that could be more effective at stopping your prostate cancer from spreading. However, there's also a chance you might receive the dummy pill. Like any medicine, darolutamide can have side effects, and the study team will monitor you closely for any issues. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (226)

Mayo Clinic Hospital - Phoenix - Cardiology
Phoenix, United States
City of Hope - Duarte Cancer Center
Duarte, United States
USC Norris Comprehensive Cancer Center
Los Angeles, United States
Tower Urology
Los Angeles, United States
UCLA Clark Urology Center
Los Angeles, United States
UCSF Bakar Precision Cancer Medicine Building - Genitourinary
San Francisco, United States
Colorado Urology - St. Anthony Hospital Campus
Lakewood, United States
Northwestern Medicine - Urology
Chicago, United States
The University of Kansas Cancer Center - Richard and Annette Bloch Radiation Oncology Pavilion
Kansas City, United States
Chesapeake Urology Associates - Towson
Baltimore, United States
Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins
Baltimore, United States
Dana-Farber Cancer Institute - Oncology Department
Boston, United States

+214 more sites — see the official record for the full list.

Common questions

What is 'biochemical recurrence'?

It means your prostate cancer's PSA levels are rising again after initial treatment, even if regular scans don't yet show the cancer.

What is ADT?

ADT stands for Androgen Deprivation Therapy. It's a type of hormone therapy that lowers male hormone levels to slow down prostate cancer growth.

What is darolutamide?

Darolutamide is a drug that works by blocking the action of male hormones on prostate cancer cells, which helps stop them from growing.

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

No, you won't know initially. This helps ensure unbiased results, but your doctor will have access to this information if medically necessary.

How long will I be in the study?

The treatment phase is planned for 24 months (two years), but you'll have follow-up checks for a longer period afterwards.