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Hormone Therapy
Abiraterone/Enzalutamide/Apalutamide for Prostate Cancer
Phase 2
Waitlist Available
Research Sponsored by James J. Peters Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Receiving or will receive androgen-deprivation therapy
Age ≥18 years of age on day of signing informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial looked at how well two different drugs work in people with a certain kind of cancer. The drugs worked well, and the people who got them had better outcomes than people who didn't. The trial was done in a group of people who all have the same kind of cancer, and the results showed that the drugs worked well in this group.
Who is the study for?
This trial is for Veterans with advanced prostate cancer who are at least 18 years old, can consent to the study, have a good performance status (able to carry out daily activities), and haven't received certain other treatments. They should be on hormone therapy but not previously treated with abiraterone, enzalutamide, or apalutamide.Check my eligibility
What is being tested?
The trial is testing three medications: Enzalutamide, Apalutamide, and Abiraterone acetate in veterans with castrate-sensitive prostate cancer. It aims to find which drug works best for improving survival without disease progression.See study design
What are the potential side effects?
Possible side effects include fatigue, high blood pressure, skin rash, nausea, decreased appetite and weight loss. There may also be risks of liver function changes and potential heart issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am undergoing or will undergo hormone therapy for my cancer.
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I am 18 years old or older.
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My prostate cancer is confirmed without specific features.
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I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PSA Progression
Secondary outcome measures
PSA Response
Trial Design
2Treatment groups
Active Control
Group I: Abiraterone AcetateActive Control1 Intervention
Group II: Standard of CareActive Control2 Interventions
Find a Location
Who is running the clinical trial?
James J. Peters Veterans Affairs Medical CenterLead Sponsor
57 Previous Clinical Trials
2,700 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am undergoing or will undergo hormone therapy for my cancer.I have a specific type of cancer or condition.I have been on a steady dose of bisphosphonates or denosumab for over 4 weeks.I can swallow pills and follow the study's rules.I have had a blood clot in my leg or lung in the last 3 months.I have a history of seizures or conditions that could lead to seizures.My condition is at high risk of getting worse or spreading.I am 18 years old or older.I have not taken specific medications or been in certain trials before.My prostate cancer is confirmed without specific features.I am fully active or can carry out light work.I haven't had hormonal or biologic therapy in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Abiraterone Acetate
- Group 2: Standard of Care
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the dangers that have been associated with Abiraterone Acetate?
"Abiraterone acetate is currently being trialled in Phase 2, meaning that while there is evidence suggesting it is safe, none yet points to the medication's efficacy."
Answered by AI
Are researchers looking for more volunteers for this clinical trial?
"The clinical trial mentioned is not currently looking for new patients, as seen on clinicaltrials.gov. This specific study was posted on 6/30/2022 and updated lastly on 6/16/2022; however, there are many other trials (1461 in total) that are still enrolling individuals."
Answered by AI
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