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Antiandrogen

Androgen Deprivation Therapy + Enzalutamide for Prostate Cancer

Phase 2

Waitlist Available

Led By William L Dahut, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have previously untreated (with definitive therapy) prostate cancer with intermediate or high risk features defined as:

- Stage T2b or T2c

Must not have

Patients with distant metastatic disease beyond N1(regional) lymph nodes on conventional imaging studies (Computed tomography (CT), MRI or Bone Scan)

- Bleeding disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post treatment, approximately 1-3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to treat prostate cancer that hasn't spread in the body. The combination of androgen deprivation therapy and enzalutamide has been shown to make patients with advanced (metastatic disease) live longer. The investigators want to see if using it earlier can increase cure rate of surgery and identify genetic or molecular characteristics that are associated with better outcomes.

Who is the study for?

Men 18+ with non-metastatic prostate cancer, eligible for surgery. Must have detectable lesions on MRI, agree to travel for follow-ups and undergo biopsy. No prior definitive therapy; intermediate/high-risk features required. Adequate contraception is necessary during and post-treatment.

What is being tested?

The trial tests if advanced imaging (mpMRI) can better detect prostate cancer pre- and post-treatment with a drug combo (androgen deprivation therapy + enzalutamide) before surgery, aiming to improve cure rates and identify genetic markers of good outcomes.

What are the potential side effects?

Potential side effects include hot flashes, fatigue, sexual dysfunction due to hormone therapy; seizures or neurological issues from enzalutamide; discomfort or risks associated with biopsies; allergic reactions to MRI contrast agents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is at an intermediate or high risk stage and has not been treated yet.

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My cancer is at stage T2b or T2c.

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My prostate cancer has a Gleason score of 8 or higher.

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My prostate cancer diagnosis was confirmed by a recognized pathology lab.

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My kidney function is normal or only slightly below normal.

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I am a man aged 18 or older.

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I am fully active or have some restrictions but can still care for myself.

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I am willing to have a biopsy.

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My prostate cancer has a Gleason score of 7.

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I am eligible for and planning to have surgery to remove my prostate.

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My cancer has spread to the seminal vesicles.

Exclusion Criteria

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

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My cancer has spread beyond the regional lymph nodes.

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I have a bleeding disorder.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I am currently being treated for Hepatitis B or C.

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I am not taking medications for urinary symptoms or any that affect PSA levels while on enzalutamide.

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I haven't had cancer that would stop me from taking study drugs or having a prostate surgery in the last 3 years.

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I do not have severe heart problems like uncontrolled high blood pressure or recent heart attacks.

Select...

I have had treatment for prostate cancer, including surgery, radiation, or chemotherapy.

Select...

I cannot undergo a biopsy due to health risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post treatment, approximately 1-3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post treatment, approximately 1-3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and post treatment, approximately 1-3 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Median Tumor Volume Burden at Baseline Multi-parametric Magnetic Resonance Imaging (mpMRI) Before and After Surgery

Secondary study objectives

Initial Multiparametric Magnetic Resonance Imaging (mpMRI) Percentage of Relative Tumor Volume Sensitivity

Initial Multiparametric Magnetic Resonance Imaging (mpMRI) Percentage of Relative Tumor Volume Specificity

Biopsy

+6 more

Other study objectives

Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1/Arm 1- Enzalutamide and GoserelinExperimental Treatment3 Interventions

Patients will have an multi-parametric magnetic resonance imaging (mpMRI) guided biopsy, then receive enzalutamide and goserelin subcutaneous (SC) treatment for 6 months followed by a second mpMRI examination.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~3820

Goserelin

2008

Completed Phase 3

~4270