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Trial · Interventional

CompletedPhase 2Results postedRegistry data

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

NCTNCT02430480 (opens ClinicalTrials.gov in a new tab)Other id150124Other id15-C-0124

Overview

Status
Completed
Phase
Phase 2
Enrollment
39 participants (actual)
Sponsor
National Cancer Institute (NCI) · Nih
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
3 Jun 2015
Primary completion
1 Dec 2019
Completion
11 Jun 2024
First posted
30 Apr 2015 (estimated)
Last update posted
16 Jul 2025
Conditions
Prostate Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162018202020222024
  1. Ph 2

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

    NCT02430480

    3 Jun 2015 to 11 Jun 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • GoserelinDrug
  • EnzalutamideDrug
  • mpMRIDevice

Arms1

  • Experimental

    1/Arm 1- Enzalutamide and Goserelin

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline and 6 months

    Registry description

    The prostate lesion is contoured manually by an expert radiologist. Research software (mim-vista) calculates the volume. Greater tumor volumes may indicate higher prostate tumor growth.

Secondary outcomes(9)
  1. Median Nuclear Androgen Receptor (AR) Level in Biopsy Specimens Versus Residual Tumors

    Time frame · 6 months

    Registry description

    The effect of intense androgen suppression and inhibition was measured on tumors using anti-AR immunostains of biopsy and surgical specimens. Detection of tumor nuclear AR was quantified on a per-nucleus basis using computer-aided image analysis with Definiens Developer XD 64, grouping nuclei into high, medium, low, and absent bins, a histology score was assigned to each sample. Nucleus classification is low vs. med. at 0.7; med. vs. high at 0.95. Definiens reported the total # of positively stained nuclei or cells, along with the distribution of low-, med.-, and high-intensity stained nuclei/cells for ea. tumor focus. A %positive index score was calculated using a weighted avg. divided by the total # of objects, where index = \[ (1 × nuclei/cells stained low) + (2 × nuclei/cells stained med.) + (3 × nuclei/cells stained high) \](3 × total nuclei).

  2. Median Prostate Lesion Volume Before and After Treatment

    Time frame · Baseline and 6 months

    Registry description

    Prostate lesion volumes on baseline and post-treatment multiparametric magnetic resonance imaging (mpMRI) were calculated from T2W-MRI sequences using software embedded in the PACS after manual contouring by the same radiologist. Lesion volume scores were categorized as low (2 or fewer positive sequences), moderate (3 positive sequences) and high (4 positive sequences). Lesion volume values are in cubic centimeters (cc's).

  3. Number of Participants With a Complete Response

    Time frame · After neoadjuvant treatment with androgen deprivation therapy (ADT) and enzalutamide, approximately 6 months

    Registry description

    Complete response was evaluated after neoadjuvant treatment with androgen deprivation therapy (ADT) and enzalutamide and assessed by pathologic exam. Pathologic complete response: the absence of residual invasive cancer confirmed by immunohistochemistry (IHC).

  4. Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

    Time frame · Date treatment consent signed to date off study, approximately 51 months and 2 days.

    Registry description

    Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

  5. Number of Prostate Lesions Detected Within the Study Population at Baseline Multi-parametric Magnetic Resonance Imaging (mpMRI) and 6 Months After Enzalutamide Plus Androgen Deprivation Therapy (ADT)

    Time frame · Baseline and 6 months

    Registry description

    Prostate lesion volumes on baseline and post-treatment mpMRI were calculated from T2W-MRI sequences using software embedded in the PACS after manual contouring by the same radiologist.

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

    Time frame · 6 months

    Registry description

    The Youden index was used as a measure for evaluating biomarker effectiveness and was calculated to determine the cutoffs that gave the optimal combination of sensitivity and specificity for patient response to treatment. The index is: J=sensitivity + specificity -1. Its value ranges from 0 through 1 (inclusive). A value of 1 indicates that there are no false positives or false negatives, i.e. the test is perfect. The index gives equal weight to false positive and false negative values, so all tests with the same value of the index give the same proportion of total misclassified results. Sensitivity and specificity are the probability of truly identifying relative tumor burden on multiparametric magnetic resonance imaging (mpMRI) respectively at a statistically established cut point.

  7. Number of Participants With Reduction in Phosphatase and Tensin Homolog (PTEN) Levels

    Time frame · post treatment, approximately 1-3 months

    Registry description

    PTEN level reduction was evaluated using immunohistochemistry in post treatment specimens. For anti-PTEN immunohistochemistry, a case was considered PTEN-reduced (abnormal) if at least 5% of tumor cells demonstrated reduced PTEN intensity relative to PTEN in benign cells (lower than 5%, then abnormal).

  8. Number of Participants With Positive Erythroblast Transformation-specific (ETS)-Related Gene (ERG) Protein Overexpression

    Time frame · Approximately one month-3 months post-treatment

    Registry description

    ERG protein overexpression was evaluated using immunohistochemistry in post treatment specimens. A positive ETS-related ERG overexpression is a bad outcome.

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

    Time frame · 6 months

    Registry description

    The Youden index was used as a measure for evaluating biomarker effectiveness and was calculated to determine the cutoffs that gave the optimal combination of sensitivity and specificity for patient response to treatment. The index is: J=sensitivity + specificity -1. Its value ranges from 0 through 1 (inclusive). A value of 1 indicates that there are no false positives or false negatives, i.e. the test is perfect. The index gives equal weight to false positive and false negative values, so all tests with the same value of the index give the same proportion of total misclassified results. Sensitivity and specificity are the probability of truly identifying relative tumor burden on multiparametric magnetic resonance imaging (mpMRI) respectively at a statistically established cut point.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Baseline and 6 months

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

GroupValue (cc)
1/Arm 1- Enzalutamide and Goserelin3.44
Secondary and other outcome results(7)
Secondary outcomeMedian· 6 months

Median Nuclear Androgen Receptor (AR) Level in Biopsy Specimens Versus Residual Tumors

GroupValue (scores on a scale)
1/Arm 1- Enzalutamide and Goserelin0.7568
Secondary outcomeMedian· Baseline and 6 months

Median Prostate Lesion Volume Before and After Treatment

GroupValue (cubic centimeters)
1/Arm 1- Enzalutamide and Goserelin39.5
Secondary outcomeCount of participants· After neoadjuvant treatment with androgen deprivation therapy (ADT) and enzalutamide, approximately 6 months

Number of Participants With a Complete Response

GroupValue (Participants)
1/Arm 1- Enzalutamide and Goserelin2
Secondary outcomeCount of participants· Date treatment consent signed to date off study, approximately 51 months and 2 days.

Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)

GroupValue (Participants)
1/Arm 1- Enzalutamide and Goserelin38
Secondary outcomeNumber· Baseline and 6 months

Number of Prostate Lesions Detected Within the Study Population at Baseline Multi-parametric Magnetic Resonance Imaging (mpMRI) and 6 Months After Enzalutamide Plus Androgen Deprivation Therapy (ADT)

GroupValue (Lesions)
1/Arm 1- Enzalutamide and Goserelin58
Secondary outcomeNumber· 6 months

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

GroupValue (Percentage of sensitivity)
1/Arm 1- Enzalutamide and Goserelin81
Secondary outcomeCount of participants· post treatment, approximately 1-3 months

Number of Participants With Reduction in Phosphatase and Tensin Homolog (PTEN) Levels

GroupValue (Participants)
1/Arm 1- Enzalutamide and Goserelin21

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
1/Arm 1- Enzalutamide and GoserelinPatients 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. Goserelin: 10.8mg administered subcutaneously every 12 weeks (2 doses) Enzalutamide: 160mg orally, daily for 24 weeks mpMRI: Multiparametric MRI - One at baseline and after 6 months of treatment1 / 392 / 3938 / 39

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2019

mpMRI preoperative staging in men treated with antiandrogen and androgen deprivation therapy before robotic prostatectomy.

Gold et al. 2019Urologic oncologycited by 8

PMID 31000430PMC8132295DOI 10.1016/j.urolonc.2019.01.012PUB-31000430

Rights unknown
Source link

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedWilkinson S, Ku AT, Lis RT, King IM, Low D, Trostel SY, Bright JR, Terrigino NT, Baj A, Summerbell ER, Heyward KE, Kartal S, Fenimore JM, Li C, Singler C, Vo B, Jansen CS, Ye H, Whitlock NC, Harmon SA, Carrabba NV, Atway R, Lake R, Takeda DY, Kissick HT, Pinto PA, Choyke PL, Turkbey B, Dahut WL, Karzai F, Sowalsky AG. Localized high-risk prostate cancer harbors an androgen receptor activity-low subpopulation susceptible to HER2 inhibition. J Clin Invest. 2025 Sep 4;135(22):e189900. doi: 10.1172/JCI189900. eCollection 2025 Nov 17. PMID 40906535
  • DerivedRathi N, Blake Z, Hyman J, Nemirovsky DR, Gelikman DG, Hesswani C, Koller C, Nethala D, Mendhiratta N, Kenigsberg AP, Noun J, Dahut W, Karzai FY, Linehan WM, Pinto PA, Turkbey B, Gurram S. Castration Levels of Testosterone Results in Atrophy of Androgen-sensitive Perineal Muscles: A Potential Biomarker for Male Hypogonadism. Urology. 2025 Feb;196:313-320. doi: 10.1016/j.urology.2024.10.006. Epub 2024 Oct 18. PMID 39427924
  • DerivedKarzai F, Walker SM, Wilkinson S, Madan RA, Shih JH, Merino MJ, Harmon SA, VanderWeele DJ, Cordes LM, Carrabba NV, Bright JR, Terrigino NT, Chun G, Bilusic M, Couvillon A, Hankin A, Williams MN, Lis RT, Ye H, Choyke PL, Gulley JL, Sowalsky AG, Turkbey B, Pinto PA, Dahut WL. Sequential Prostate Magnetic Resonance Imaging in Newly Diagnosed High-risk Prostate Cancer Treated with Neoadjuvant Enzalutamide is Predictive of Therapeutic Response. Clin Cancer Res. 2021 Jan 15;27(2):429-437. doi: 10.1158/1078-0432.CCR-20-2344. Epub 2020 Oct 6. PMID 33023952

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
* 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. EXCLUSION CRITERIA: * Patients who are receiving any other investigational agents (in the past 28 days) or herbal medications (within 1 day). * Patients with distant metastatic disease beyond N1(regional) lymph nodes on conventional imaging studies (Computed tomography (CT), MRI or Bone Scan). * Patients who have received any prior therapy for prostate cancer with surgery, radiation, and/or chemotherapy * History of allergic reactions attributed to compounds of similar chemical or biologic composition to enzalutamide or other agents used in study. * 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). * 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 * 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 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 with known active treatment for Hepatitis B and C infections. * 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 * Patients with a malignancy within the past 3 years for which study drugs or a prostatectomy is a contraindication.

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