NCT02430480CompletedPhase 2

Using Multiparametric MRI to Evaluate Intraprostatic Tumor Responses and Androgen Resistance Patterns in Newly Diagnosed Prostate Cancer

Neoadjuvant Androgen Deprivation and Enzalutamide: Using Multiparametric MRI to Evaluate Intraprostatic Tumor Responses and Androgen Resistance Patterns in Newly Diagnosed Prostate Cancer

Source: ClinicalTrials.gov · Last updated 16 Jul 2025

Brief summary (registry, in English)

Background: * There are several ways to treat prostate cancer. Researchers want to see how well a certain kind of imaging helps detect prostate cancer. They also want to see if a particular drug combination used before surgery will benefit people with prostate cancer that hasn't spread in the body (non-metastatic). The combination will be androgen deprivation therapy and enzalutamide. * 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. Objectives: \- To develop better ways of detecting prostate cancer before and after pre-operative treatment. Eligibility: \- Men at least 18 years old with non-metastatic prostate cancer. They must be candidates for a radical prostatectomy. Design: * Participants will be screened with medical history, physical exam, and blood tests. They will have scans and X-rays. * Before starting the study drugs, participants will have: * Vital signs taken, medical history, and blood tests. * Electrocardiogram (ECG) heart test, with patches stuck on the skin. * Small piece of tumor removed (biopsy) using image guidance from magnetic resonance imaging (MRI) and ultrasound. * 3T multi-parametric magnetic resonance imaging (mpMRI). Participants will lie on a table that slides into a metal cylinder. A probe will be inserted in the rectum. They will be in the scanner for about 60 minutes, lying still. The scanner makes loud knocking sounds. Participants will get earplugs. * Participants will take the 2 study drugs for 6 months. * Enzalutamide is taken as 4 pills once a day. * Androgen deprivation therapy is given by injection 2 times over 6 months. * During these 6 months, participants will visit the clinic monthly. They will have physical exam, vital signs, and blood drawn. * After finishing the study drugs, participants will have another 3T mpMRI. Then they will have prostate removal surgery.

Status (registry): Completed
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 39 (actual)
First submitted: 28 Apr 2015
Start date: 3 Jun 2015
Primary completion date: 1 Dec 2019
Lead sponsor: National Cancer Institute (NCI)
Diseases: Prostate cancer
NCT number: NCT02430480

What you commit to

Study type: Interventional · Phase 2
Participants enrolled: 39
From 3 Jun 2015 to the primary completion date, 1 Dec 2019
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Patients who are receiving any other investigational agents (in the past 28 days) or herbal medications (within 1 day).
Patients who have received any prior therapy for prostate cancer with surgery, radiation, and/or chemotherapy
Clinically significant cardiac disease, e.g. New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by an electrocardiogram (ECG).
Patients with known human immunodeficiency virus (HIV) are eligible. These patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. In addition, if patients are receiving combination antiretroviral therapy, there is potential for pharmacokinetic interactions with enzalutamide. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.
Patients who are taking medications that are strong inhibitors of Cytochrome P450 3A4 (CYP3A4) or P-glycoprotein (PgP) and need to remain on these medications. For a current table of Substrates, Inhibitors and Inducers please access the following website:
- http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm093664.htm
History of seizure, including any febrile seizure, loss of consciousness, or transient ischemic attack, or any condition that may pre-dispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization).
Other medications used for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter prostate specific antigen (PSA) (eg phytoestrogens and saw palmetto) cannot be taken while patients are receiving enzalutamide

Other illness

Patients with distant metastatic disease beyond N1(regional) lymph nodes on conventional imaging studies (Computed tomography (CT), MRI or Bone Scan).
History of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide or other agents used in study.
Contraindication to MRI:
- Patients weighing more than weight limit for the scanner tables
- Allergy to MR contrast agent
- Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic device
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients with known active treatment for Hepatitis B and C infections.
Patients with a malignancy within the past 3 years for which study drugs or a prostatectomy is a contraindication.

Lab values

Contraindication to biopsy:
- Bleeding disorders
- Prothrombin Time (PT)/Partial Thromboplastin Time (PTT) greater than or equal to 1.5 times the upper limit of normal
- Artificial heart valve

Criteria the registry did not label

INCLUSION CRITERIA:
Patients must have histologically or cytologically confirmed prostate cancer confirmed by the Laboratory of Pathology, National Cancer Institute (NCI) or Pathology Department at Walter Reed Bethesda
Must have previously untreated (with definitive therapy) prostate cancer with intermediate or high risk features defined as:
- Intermediate risk:
- Prostate-specific antigen, (PSA) level is between 10 and 20 ng/ml or
- Gleason score is 7 or
- Stage T2b or T2c
- High Risk:
- Gleason 8 and higher OR
- PSA greater than 20 at the time of diagnosis OR
- Seminal vesicle involvement OR
- Possible (on magnetic resonance imaging (MRI) Extra-capsular extension (T3 disease)
Patients must be eligible for and must be planning to undergo radical prostatectomy
Patients must have testosterone levels greater than or equal to 100 ng/dL
Men age greater than or equal to 18 years.
- Children are excluded because prostate cancer is not common in pediatric populations.
- Women are not eligible because this disease occurs only in men.
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
Patients must have normal organ and marrow function as defined below:
Hemoglobin greater than or equal to 9 g/dL
leukocytes greater than or equal to 3,000/mcL
absolute neutrophil count greater than or equal to 1,500/mcL
platelets greater than or equal to 150,000/mcL
total bilirubin within normal institutional limits
Aspartate aminotransferase (AST)/Serum glutamic-oxaloacetic transaminase(SGOT)/Alanine aminotransferase (ALT) Serum glutamic pyruvic transaminase (SGPT) less than or equal to 3 X institutional upper limit of normal
creatinine within normal institutional limits
- OR
creatinine clearance greater than or equal to 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal.
The effects of enzalutamide on the developing human fetus are unknown. For this reason and because androgen receptor antagonists as well as other therapeutic agents used in this trial are known to be teratogenic, male participants and their female partners of child bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence). Male participants should use a condom if having intercourse with a pregnant woman. Additionally, a condom plus another effective method of birth control is recommended during therapy and for 3 months after treatment for male participants having intercourse with a woman of reproductive potential. Should a woman become pregnant or suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately.
Ability of subject to understand and the willingness to sign a written informed consent document.
Willingness to undergo biopsy.
Ability to detect lesions within prostate on magnetic resonance imaging (MRI) for biopsy
Willingness to travel to National Institutes of Health (NIH) for follow-up visits.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Institutes of Health Clinical Center, 9000 Rockville Pike Coordinator of this site? Confirm its status	Bethesda	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.