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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

Must not have

Use of investigational agents or herbal products affecting PSA levels

Known or suspected brain metastasis or active leptomeningeal disease

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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not using any experimental drugs or herbal products that affect PSA levels.

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I have brain metastasis or active leptomeningeal disease.

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I have a history of seizures or conditions that could lead to seizures.

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My cancer is not adenocarcinoma.

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My cancer has spread through my lymphatic system or blood.

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I have a serious heart condition.

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I have had interstitial lung disease or pneumonitis.

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I have a known HIV, HBV, or HCV infection.

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I have recently used specific medications or treatments.

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I have a history or risk of eye blood vessel blockage or swelling.

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I have had another type of cancer in the last 5 years.

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I have received treatment for prostate cancer before.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and prostatectomy will occur during the 2 week "window" between 6 and 8 weeks after enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

N-cadherin and vimentin expression

Awards & Highlights

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 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 19Eligibility criteria met