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Hormone Therapy
Hormone Therapy + Targeted Drugs for Prostate Cancer
Phase 2
Waitlist Available
Led By Robert Reiter, M.D.
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with adenocarcinoma of the prostate with planned radical prostatectomy (RP) with curative intent
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prostatectomy will occur during the 2 week "window" between 6 and 8 weeks after enrollment
Awards & highlights
Study Summary
This trial is testing whether adding targeted drugs to hormone therapy can improve outcomes for men with prostate cancer.
Who is the study for?
Men over 18 with advanced prostate cancer who haven't had treatment for it yet can join this trial. They should be planning to have surgery, be in good health otherwise, and have a life expectancy of at least 6 months. Key requirements include normal organ function tests, no history of heart failure or arrhythmias, and they must use contraception.Check my eligibility
What is being tested?
The study is testing if adding targeted cancer drugs (dasatinib or trametinib) to hormone therapy before surgery helps more than just hormone therapy alone. Men will get either the hormone drug degarelix plus enzalutamide or that combo with one of the other drugs.See study design
What are the potential side effects?
Possible side effects include blood clots, liver problems, high blood pressure, fatigue, skin reactions like rash or dryness, diarrhea or constipation. There's also a risk of heart issues such as low ejection fraction.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am diagnosed with prostate cancer and scheduled for surgery to remove it.
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I am fully active or can carry out light work.
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I am a candidate for major prostate surgery.
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My tumor can be easily reached for a biopsy.
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I am 18 years old or older.
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My prostate cancer is localized and not spread.
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I can take pills and have no major stomach or intestine issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ prostatectomy will occur during the 2 week "window" between 6 and 8 weeks after enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~prostatectomy will occur during the 2 week "window" between 6 and 8 weeks after enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
N-cadherin and vimentin expression
Trial Design
3Treatment groups
Active Control
Group I: AR inhibition onlyActive Control2 Interventions
AR inhibition only Group 1: degarelix + enzalutamide
Endocrine therapy with degarelix and enzalutamide will continue for a minimum of 6 weeks and a maximum of 8 weeks in all groups prior to the planned prostatectomy.
Group II: AR inhibition plus MEK inhibitionActive Control3 Interventions
AR inhibition plus MEK inhibition Group 2: trametinib + degarelix + enzalutamide
In Group 2, treatment with trametinib will begin on Day 29 (i.e. four weeks after initiation of androgen deprivation). Thus, trametinib will be administered for no less than two weeks and no more than four weeks.
Group III: AR inhibition plus SRC inhibitionActive Control3 Interventions
AR inhibition plus SRC inhibition Group 3: dasatinib + degarelix + enzalutamide
In Group 3, treatment with dasatinib will begin on Day 29 (i.e. four weeks after initiation of androgen deprivation). Thus, dasatinib will be administered for no less than two weeks and no more than four weeks.
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Who is running the clinical trial?
NovartisIndustry Sponsor
1,610 Previous Clinical Trials
2,719,225 Total Patients Enrolled
21 Trials studying Prostate Cancer
4,889 Patients Enrolled for Prostate Cancer
Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,030 Total Patients Enrolled
38 Trials studying Prostate Cancer
3,955 Patients Enrolled for Prostate Cancer
Medivation, Inc.Industry Sponsor
75 Previous Clinical Trials
11,197 Total Patients Enrolled
11 Trials studying Prostate Cancer
623 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not using any experimental drugs or herbal products that affect PSA levels.I am diagnosed with prostate cancer and scheduled for surgery to remove it.I have brain metastasis or active leptomeningeal disease.I have a history of seizures or conditions that could lead to seizures.My cancer is not adenocarcinoma.My cancer has spread through my lymphatic system or blood.I have a serious heart condition.I have had interstitial lung disease or pneumonitis.I have a known HIV, HBV, or HCV infection.I have recently used specific medications or treatments.I have a history or risk of eye blood vessel blockage or swelling.I am fully active or can carry out light work.I have had another type of cancer in the last 5 years.I do not have any health issues that would make it unsafe for me to join a study.I am a candidate for major prostate surgery.My tumor can be easily reached for a biopsy.I am 18 years old or older.My kidney, liver, blood, clotting, and heart functions are all normal.My prostate cancer is localized and not spread.I can take pills and have no major stomach or intestine issues.I have received treatment for prostate cancer before.
Research Study Groups:
This trial has the following groups:- Group 1: AR inhibition only
- Group 2: AR inhibition plus MEK inhibition
- Group 3: AR inhibition plus SRC inhibition
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.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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.
Are there any opportunities for new participants to join this trial?
"No, this research trial is not currently accepting volunteers. It was initially posted on September 23rd 2014 and last edited August 25th 2022. There are 1321 other studies actively registering participants with prostate cancer, as well as 275 more for AR inhibition specifically that are now open to applicants."
Answered by AI
For which ailments is AR inhibition typically prescribed?
"AR Inhibition is the recommended treatment course for those with unresectable melanoma, advanced prostate cancer, and castration resistant forms of these cancers."
Answered by AI
Are there any other research endeavors that have focused exclusively on AR inhibition?
"Presently, there are 275 active clinical trials focused on the inhibition of AR. 51 of those studies have moved into Phase 3 and most originate in Saint Louis, Missouri; however, across 15391 different sites worldwide research on this intervention is being conducted."
Answered by AI
What have been the effects of AR inhibition on human beings?
"Based on the available evidence, the team at Power gave AR inhibition a safety rating of 2. This is because there's been limited testing to prove its efficacy but some data demonstrating its potential for being safe."
Answered by AI
What is the total capacity of this research trial?
"No longer accepting participants, this medical experiment was initially posted on September 23rd 2014 and made its last edit on August 25th 2022. Fortunately, there are numerous other clinical trials enrolling patients with prostate cancer (1321), as well as those researching AR inhibition specifically (275)."
Answered by AI
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