The LIBERTAS STUDY is researching a way to potentially treat a type of prostate cancer that still responds to hormone therapy. Prostate cancer that spreads to other parts of the body but can still be controlled by interfering with the hormone function of the cancer is called metastatic castration-sensitive prostate cancer (mCSPC).
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC (LIBERTAS)
Why is this Clinical Research Study Being Done?
Doctors want to see if after a participant with prostate cancer responds to an investigational medication and hormone therapy for the first six months of receiving it, it is possible to take breaks from taking the hormone therapy.
Doctors are checking to see if this approach helps in two main ways:
- Keeping the cancer from growing or spreading as seen on imaging tests like CT, MRI or bone
- Reducing how often or how severe your hot flashes Hot flashes are a common side effect of hormone therapy.
What does participation in this study involve?
After the first six months of treatment with the investigational medication and hormone therapy if your blood test shows a decrease in Prostate Specific Antigen (PSA a protein in the blood that can indicate the presence of prostate cancer) to below a certain level you would either continue with both treatments or switch to taking breaks from the hormone therapy. Your PSA levels will be checked regularly for at least 18 months to monitor the effects. The safety and efficacy of the use of the investigational medications in this way have not been established.
Who is Eligible to be in the LIBERTAS Study?
To be part of the LIBERTAS study, participants must:
- Have a diagnosis of metastatic prostate cancer confirmed through specific tests.
- Show that the cancer has spread to more than one place outside the prostate through imaging tests like CT, MRI, or bone scans.
- Be in good enough health to participate.
- Be able to swallow the medication tablets.
- Participants who have had surgery to remove both testicles and/or are on hormone therapy as part of gender-affirming care.
Interested in Participation?
To learn more about this study, if you may be eligible and if the study is being conducted at a site near you, please visit: Clinicaltrials.gov or Janssen Clinical Trial Finder\LIBERTAS. To learn more about clinical trials, please visit: About Clinical Trials\Janssen Clinical Trial Finder
Locations
The study is happening in many places across the United States, including Alabama, Arizona, Arkansas, California, Colorado, Florida, Illinois, Indiana, Maryland, Michigan, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah and Virginia. If you or someone you know has metastatic castration-sensitive prostate cancer and meets the criteria, this study might offer an option.
To learn more, visit the official trial registration or contact the recruiting sites near you. Participation in any clinical trial is an important decision that should be made in consultation with your doctor.
Organization:
Janssen Research & Development, LLC
Janssen Global Trial Finder: ERLEADA – LIBERTAS Study
Clinical Trials.gov Information:
- NCT Number: NCT05884398
- Title: A Study of an Intermittent ADT Approach with Apalutamide Monotherapy in Participants With mCSPC (LIBERTAS)
Use the “clinical trials glossary” and “dictionary” for words, phrases and treatments that you may not understand.
Register your interest or comments about this trial with PHEN
Please Note: This information is provided for educational and awareness purposes. A decision on clinical trials participation is to be made between the patient and his doctor.
