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Antiandrogen
Anti-Testosterone Drugs + Radiation Therapy for Prostate Cancer
Phase 2
Waitlist Available
Led By Sean M McBride, MD, MPH
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males 18 years of age and above
Radiographic stage ≥T3 disease as determined by a ≥75% probability of extracapsular extension or seminal vesicle invasion per reading radiologist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study Summary
This trial will test whether anti-testosterone drugs can stop prostate cancer from recurring after high-dose radiation therapy.
Who is the study for?
Men over 18 with advanced prostate cancer, not previously treated for it, can join this trial. They need a PSA level ≥20 ng/mL and clinical stage ≥T3 disease. Key organ functions must be normal, including liver and kidney tests. Participants should have no active infections like HIV or hepatitis that would make steroid use risky, no recent other cancer treatments or surgeries, and agree to use contraception during the study.Check my eligibility
What is being tested?
The trial is testing if anti-testosterone drugs (Abiraterone and ARN-509) combined with Leuprolide and high-dose precision radiotherapy can prevent prostate cancer from returning. Patients will receive these medications before, during, and after the radiation treatment to see how effective they are together.See study design
What are the potential side effects?
Possible side effects include hormonal changes due to testosterone suppression which may cause fatigue, hot flashes, sexual dysfunction; liver function changes; potential impact on heart rhythm; gastrointestinal issues affecting drug absorption; risk of seizures in susceptible individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man aged 18 or older.
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My cancer is advanced, with a high chance of spreading beyond its original location.
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My prostate cancer is aggressive (Gleason score 9-10 or >4 cores of Gleason 8).
Select...
I am mostly able to care for myself.
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My prostate cancer is high-risk or has a Gleason score of 8-10.
Select...
My prostate cancer diagnosis was confirmed with a tissue test.
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My prostate cancer is advanced, as confirmed by a physical exam.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
proportion of patients with biochemical failure
Trial Design
1Treatment groups
Experimental Treatment
Group I: patients with prostate cancerExperimental Treatment4 Interventions
Eligible patients will receive a total of 6 months of leuprolide, abiraterone, and ARN-509 to begin three months prior to RT and continuing until approximately 3 months post-RT. Patients will be assessed every 4 weeks (±1 week) (a cycle = 28 days) throughout their treatment with the study drugs, and at least once during RT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abiraterone
2012
Completed Phase 4
~2830
ARN-509
2013
Completed Phase 2
~110
Leuprolide
2008
Completed Phase 4
~18970
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,140 Total Patients Enrolled
132 Trials studying Prostate Cancer
52,010 Patients Enrolled for Prostate Cancer
Janssen PharmaceuticalsIndustry Sponsor
80 Previous Clinical Trials
205,007 Total Patients Enrolled
4 Trials studying Prostate Cancer
176 Patients Enrolled for Prostate Cancer
Weill Medical College of Cornell UniversityOTHER
1,054 Previous Clinical Trials
1,316,552 Total Patients Enrolled
48 Trials studying Prostate Cancer
35,575 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a specific type of inflammatory bowel disease.I have a specific condition affecting my digestive system.I have active symptoms of viral hepatitis or chronic liver disease.I have had heart problems within a certain time frame.I have a stomach or intestine problem that affects how I absorb medications.My liver is severely damaged.I have not taken certain medications recently.I have seizures or conditions that could lead to seizures.I do not have uncontrolled diabetes, heart disease, or high blood pressure.I cannot undergo MRI or have markers placed in my body.My pelvic or retroperitoneal lymph nodes are smaller than 1.5 cm.I haven't had any other cancer besides this one in the last 3 years.I am not taking medication that strongly activates liver enzymes.I have not had major surgery in the last 4 weeks.I am a man aged 18 or older.My cancer is advanced, with a high chance of spreading beyond its original location.My prostate cancer is aggressive (Gleason score 9-10 or >4 cores of Gleason 8).I am mostly able to care for myself.My prostate cancer is high-risk or has a Gleason score of 8-10.My scans show I have at least one cancerous lymph node.I have had issues with my pituitary or adrenal glands.My prostate cancer diagnosis was confirmed with a tissue test.I do not have any infections or conditions that prevent me from taking prednisone.I have had prostate cancer treatment, but only hormone therapy for less than a month with approval.I do not have an active infection or a condition that prevents steroid use.My prostate cancer is advanced, as confirmed by a physical exam.
Research Study Groups:
This trial has the following groups:- Group 1: patients with prostate cancer
Awards:
This trial has 1 awards, including:- 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.
Has the FDA cleared stereotactic, ultra-fractionated radiotherapy for patient use?
"There is limited data supporting the safety of stereotactic, ultra-fractionated radiotherapy, which Power has rated a 2 on its 3-point scale."
Answered by AI
Are there any other investigations that have looked at using ultra-fractionated radiotherapy in a stereotactic way?
"The original study into stereotactic, ultra-fractionated radiotherapy was published in 2004 by researchers at SUNY Downstate Medical Center. Since then, there have been 248 completed studies on the topic. As of now, there are 177 clinical trials actively recruiting patients; a large number of these trials are based in Uniondale, New york."
Answered by AI
How many people fit the requirements for this research project?
"Unfortunately, this study is no longer recruiting patients. Although the listing was last updated on February 8th, 2022, recruitment for this trial ended long ago. There are still 1367 other clinical trials enrolling patients with prostate cancer and 177 trials for stereotactic, ultra-fractionated radiotherapy that are actively seeking participants."
Answered by AI
What do doctors usually treat with stereotactic, ultra-fractionated radiotherapy?
"Stereotactic, ultra-fractionated radiotherapy can be used to target and treat advanced prostate cancer, castration, and resistance to hormone therapy."
Answered by AI
In how many different medical clinics is this clinical trial being run today?
"This study is looking for participants from 11 different enrolment sites, including Uniondale, Rockville Centre and New york. To limit travel burdens, patients are encouraged to choose the closest location to them."
Answered by AI
Are new participants being enrolled in this experiment at the moment?
"This particular study is not looking for new patients at the moment. The listing was created on May 1st, 2016 and last updated on February 8th, 2022. There are other active clinical trials though; 1367 recruiting prostate cancer patients and 177 studies seeking participants that will receive stereotactic, ultra-fractionated radiotherapy."
Answered by AI
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