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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
- Intermediate risk:
Must have previously untreated (with definitive therapy) prostate cancer with intermediate or high risk features defined as:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post treatment, approximately 1-3 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 condition is considered to be of intermediate risk.
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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 MRI shows my cancer has grown beyond the organ it started in.
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My kidney function is normal or only slightly below normal.
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I agree to use effective birth control during and for 3 months after the study.
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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.
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My organ and bone marrow functions are normal.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median Tumor Volume Burden at Baseline Multi-parametric Magnetic Resonance Imaging (mpMRI) Before and After Surgery
Secondary outcome measures
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 outcome measures
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research

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
Goserelin
2008
Completed Phase 3
~7100
Enzalutamide
2014
Completed Phase 4
~2760
mpMRI
2014
N/A
~370

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,915,607 Total Patients Enrolled
559 Trials studying Prostate Cancer
507,115 Patients Enrolled for Prostate Cancer
William L Dahut, M.D.Principal InvestigatorNational Cancer Institute (NCI)
11 Previous Clinical Trials
3,698 Total Patients Enrolled
6 Trials studying Prostate Cancer
2,464 Patients Enrolled for Prostate Cancer
Fatima Karzai, M.D.Principal InvestigatorNational Cancer Institute (NCI)

Media Library

Enzalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT02430480 — Phase 2
Prostate Cancer Research Study Groups: 1/Arm 1- Enzalutamide and Goserelin
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT02430480 — Phase 2
Enzalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02430480 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is sign-up for this trial open now?

"Per the information provided on clinicaltrials.gov, no further candidates are being recruited for this study which was posted in June 2015 and edited lastly in June 2022. However, there are 1472 other trials that remain open to potential participants at present time."

Answered by AI

What is the current tally of participants in this research project?

"This clinical trial has ceased recruitment of new participants. Initially published on June 3rd 2015, it was last updated on June 27th 2022. Currently 1315 studies are searching for prostate cancer patients and 157 trials require mpMRI volunteers."

Answered by AI

What is the current regulatory status of mpMRI?

"The safety of mpMRI is thought to be a 2, as it has not yet seen efficacy results in its Phase 2 trial but there is evidence that supports the drug's security."

Answered by AI

What is the predominant purpose of magnetic resonance imaging (MRI)?

"Magnetic particle imaging (mpMRI) is frequently employed for radiation therapy, but can also be beneficial in relieving pain associated with end-of-life care and reducing uterine haemorrhages."

Answered by AI

Is this particular experiment a new endeavor?

"mpMRI has been studied since the year 2000, when AstraZeneca sponsored a clinical trial involving 600 participants. The drug was granted Phase 3 approval soon after and currently there are 157 active studies of mpMRI spanning 59 countries and 2082 cities."

Answered by AI
Recent research and studies
~4 spots leftby Mar 2025