Trial Outcomes & Findings for Using Multiparametric MRI to Evaluate Intraprostatic Tumor Responses and Androgen Resistance Patterns in Newly Diagnosed Prostate Cancer (NCT NCT02430480)

Last Updated: 2025-07-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2025-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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 treatment
Overall Study STARTED	39
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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 treatment
Overall Study Death	1
Overall Study Anesthesia concerns	1
Overall Study Progressed on treatment	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1/Arm 1- Enzalutamide and Goserelin n=39 Participants 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. 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 treatment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants
Median Prostate-Specific Antigen (PSA) at Baseline	9.56 ng/ml n=5 Participants
Number of Participants Pre-Treatment Clinical Stage at Baseline T2	6 Participants n=5 Participants
Number of Participants Pre-Treatment Clinical Stage at Baseline T3a	17 Participants n=5 Participants
Number of Participants Pre-Treatment Clinical Stage at Baseline T3b	11 Participants n=5 Participants
Number of Participants Pre-Treatment Clinical Stage at Baseline T4	5 Participants n=5 Participants
Number of Participants Pre-Treatment Clinical Stage at Baseline N1	11 Participants n=5 Participants
Median Prostate Volume on Magnetic Resonance Imaging at Baseline	42.0 cc n=5 Participants
Median Prostate Specific Antigen (PSA) Density	0.22 ng/ml^2 n=5 Participants
Median Magnetic Resonance Tumor Burden	3.47 Ratio n=5 Participants
Number of Participants in a Gleason Group (biopsy) 1	0 Participants n=5 Participants
Number of Participants in a Gleason Group (biopsy) 2	6 Participants n=5 Participants
Number of Participants in a Gleason Group (biopsy) 3	5 Participants n=5 Participants
Number of Participants in a Gleason Group (biopsy) 4	11 Participants n=5 Participants
Number of Participants in a Gleason Group (biopsy) 5	17 Participants n=5 Participants
Number of Participants in a Risk-Group Intermediate	3 Participants n=5 Participants
Number of Participants in a Risk-Group High	36 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Population: 37 out of 39 patients completed treatment and underwent pre- and post- mpMRI. Two patients did not-one patient died on study from a recreational drug overdose. The other had progression of disease on study.

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.

Outcome measures

Outcome measures
Measure	1/Arm 1- Enzalutamide and Goserelin n=37 Participants 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. 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 treatment	Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 2 is moderate, minimal.	Grade 3 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 3 is severe or medically significant but not immediately life threatening,
Median Tumor Volume Burden at Baseline Multi-parametric Magnetic Resonance Imaging (mpMRI) Before and After Surgery Baseline	3.44 cc Interval 0.44 to 54.75	—	—
Median Tumor Volume Burden at Baseline Multi-parametric Magnetic Resonance Imaging (mpMRI) Before and After Surgery 6 months	0.62 cc Interval 0.0 to 102.4	—	—

SECONDARY outcome

Timeframe: 6 months

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).

Outcome measures

Outcome measures
Measure	1/Arm 1- Enzalutamide and Goserelin n=37 Participants 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. 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 treatment	Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 2 is moderate, minimal.	Grade 3 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 3 is severe or medically significant but not immediately life threatening,
Median Nuclear Androgen Receptor (AR) Level in Biopsy Specimens Versus Residual Tumors biopsy specimen	0.7568 scores on a scale Interval -0.5 to 0.87	—	—
Median Nuclear Androgen Receptor (AR) Level in Biopsy Specimens Versus Residual Tumors residual tumor	0.1661 scores on a scale Interval 0.0 to 0.7	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

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).

Outcome measures

Outcome measures
Measure	1/Arm 1- Enzalutamide and Goserelin n=37 Participants 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. 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 treatment	Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 2 is moderate, minimal.	Grade 3 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 3 is severe or medically significant but not immediately life threatening,
Median Prostate Lesion Volume Before and After Treatment Baseline	39.5 cubic centimeters Interval 18.9 to 73.0	—	—
Median Prostate Lesion Volume Before and After Treatment 6 months	20.0 cubic centimeters Interval 10.1 to 103.0	—	—

SECONDARY outcome

Timeframe: After neoadjuvant treatment with androgen deprivation therapy (ADT) and enzalutamide, approximately 6 months

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).

Outcome measures

Outcome measures
Measure	1/Arm 1- Enzalutamide and Goserelin n=37 Participants 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. 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 treatment	Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 2 is moderate, minimal.	Grade 3 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 3 is severe or medically significant but not immediately life threatening,
Number of Participants With a Complete Response	2 Participants	—	—

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approximately 51 months and 2 days.

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.

Outcome measures

Outcome measures
Measure	1/Arm 1- Enzalutamide and Goserelin n=39 Participants 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. 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 treatment	Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 2 is moderate, minimal.	Grade 3 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 3 is severe or medically significant but not immediately life threatening,
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)	38 Participants	—	—

SECONDARY outcome

Timeframe: Baseline and 6 months

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.

Outcome measures

Outcome measures
Measure	1/Arm 1- Enzalutamide and Goserelin n=37 Participants 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. 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 treatment	Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 2 is moderate, minimal.	Grade 3 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 3 is severe or medically significant but not immediately life threatening,
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) Baseline	58 Lesions	—	—
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) 6 months	40 Lesions	—	—

SECONDARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure	1/Arm 1- Enzalutamide and Goserelin n=37 Participants 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. 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 treatment	Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 2 is moderate, minimal.	Grade 3 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 3 is severe or medically significant but not immediately life threatening,
Initial Multiparametric Magnetic Resonance Imaging (mpMRI) Percentage of Relative Tumor Volume Sensitivity	81 Percentage of sensitivity	—	—

SECONDARY outcome

Timeframe: post treatment, approximately 1-3 months

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).

Outcome measures

Outcome measures
Measure	1/Arm 1- Enzalutamide and Goserelin n=37 Participants 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. 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 treatment	Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 2 is moderate, minimal.	Grade 3 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 3 is severe or medically significant but not immediately life threatening,
Number of Participants With Reduction in Phosphatase and Tensin Homolog (PTEN) Levels	21 Participants	—	—

SECONDARY outcome

Timeframe: Approximately one month-3 months post-treatment

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

Outcome measures

Outcome measures
Measure	1/Arm 1- Enzalutamide and Goserelin n=37 Participants 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. 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 treatment	Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 2 is moderate, minimal.	Grade 3 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 3 is severe or medically significant but not immediately life threatening,
Number of Participants With Positive Erythroblast Transformation-specific (ETS)-Related Gene (ERG) Protein Overexpression	14 Participants	—	—

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	1/Arm 1- Enzalutamide and Goserelin n=36 Participants 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. 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 treatment	Grade 2 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 2 is moderate, minimal.	Grade 3 Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 3 is severe or medically significant but not immediately life threatening,
Initial Multiparametric Magnetic Resonance Imaging (mpMRI) Percentage of Relative Tumor Volume Specificity	87 Percentage of specificity	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 51 months and 2 days.

Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event (i.e., Grade 1) is any untoward medical occurrence. A serious adverse event (i.e., Grade 2-3) is an adverse event or suspected adverse reaction that results in an adverse drug experience, and/or disruption of the ability to conduct normal life functions attributable to the research.

Outcome measures

Outcome measures
Measure	1/Arm 1- Enzalutamide and Goserelin n=39 Participants 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. 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 treatment	Grade 2 n=39 Participants Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 2 is moderate, minimal.	Grade 3 n=39 Participants Common Terminology Criteria for Adverse Events (CTCAE) v4 Grade 3 is severe or medically significant but not immediately life threatening,
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Dizziness	5 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Memory impairment	3 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Concentration impairment	3 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Fatigue	20 Adverse events	2 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Edema, limbs	2 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Erectile dysfunction	9 Adverse events	3 Adverse events	1 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Gynecomastia	3 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Dysuria	1 Adverse events	1 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Hot flashes	34 Adverse events	1 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Hypertension	1 Adverse events	7 Adverse events	7 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Confusion	2 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Libido decreased	15 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Urinary incontinence	2 Adverse events	4 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Insomnia	12 Adverse events	4 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Mood changes	2 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Personality change	3 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Restlessness	2 Adverse events	1 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Headache	5 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Dysgeusia	1 Adverse events	1 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Dyspepsia	2 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Nausea	4 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Cough	3 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Sore throat	2 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Arthralgia	2 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Back pain	3 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Muscle weakness	2 Adverse events	0 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Myalgia	2 Adverse events	1 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Rash	1 Adverse events	2 Adverse events	0 Adverse events
Any Grade 1 Adverse Events in More Than One Patient and Grades 2 -3 Attributable to Research Weight gain	2 Adverse events	0 Adverse events	0 Adverse events

Adverse Events

1/Arm 1- Enzalutamide and Goserelin

Serious events: 2 serious events

Other events: 38 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	1/Arm 1- Enzalutamide and Goserelin n=39 participants at risk 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. 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 treatment
General disorders Sudden death NOS	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Vascular disorders Thromboembolic event	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.

Other adverse events

Other adverse events
Measure	1/Arm 1- Enzalutamide and Goserelin n=39 participants at risk 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. 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 treatment
Renal and urinary disorders Acute kidney injury	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Investigations Alanine aminotransferase increased	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Metabolism and nutrition disorders Anorexia	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Psychiatric disorders Anxiety	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Musculoskeletal and connective tissue disorders Arthralgia	7.7% 3/39 • Number of events 3 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Investigations Aspartate aminotransferase increased	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Musculoskeletal and connective tissue disorders Back pain	10.3% 4/39 • Number of events 4 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Renal and urinary disorders Bladder spasm	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Eye disorders Blurred vision	7.7% 3/39 • Number of events 3 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Reproductive system and breast disorders Breast pain	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
General disorders Chills	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Investigations Cholesterol high	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Nervous system disorders Cognitive disturbance	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Nervous system disorders Concentration impairment	7.7% 3/39 • Number of events 3 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Psychiatric disorders Confusion	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Gastrointestinal disorders Constipation	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Respiratory, thoracic and mediastinal disorders Cough	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Metabolism and nutrition disorders Dehydration	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Psychiatric disorders Depression	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Gastrointestinal disorders Diarrhea	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Nervous system disorders Dizziness	15.4% 6/39 • Number of events 6 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Skin and subcutaneous tissue disorders Dry skin	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Nervous system disorders Dysgeusia	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Gastrointestinal disorders Dyspepsia	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
General disorders Edema limbs	7.7% 3/39 • Number of events 3 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Reproductive system and breast disorders Ejaculation disorder	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Respiratory, thoracic and mediastinal disorders Epistaxis	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Reproductive system and breast disorders Erectile dysfunction	30.8% 12/39 • Number of events 12 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Injury, poisoning and procedural complications Fall	7.7% 3/39 • Number of events 3 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
General disorders Fatigue	59.0% 23/39 • Number of events 24 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
General disorders Fever	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Eye disorders Floaters	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
General disorders Flu like symptoms	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Injury, poisoning and procedural complications Fracture	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Gastrointestinal disorders Gastroesophageal reflux disease	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Reproductive system and breast disorders Gynecomastia	7.7% 3/39 • Number of events 3 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Nervous system disorders Headache	15.4% 6/39 • Number of events 6 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Vascular disorders Hematoma	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Renal and urinary disorders Hematuria	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Vascular disorders Hot flashes	89.7% 35/39 • Number of events 36 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Vascular disorders Hypertension	43.6% 17/39 • Number of events 28 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Metabolism and nutrition disorders Hypophosphatemia	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Psychiatric disorders Insomnia	38.5% 15/39 • Number of events 16 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Psychiatric disorders Libido decreased	38.5% 15/39 • Number of events 15 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Vascular disorders Lymphocele	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Nervous system disorders Memory impairment	7.7% 3/39 • Number of events 3 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Musculoskeletal and connective tissue disorders Myalgia	7.7% 3/39 • Number of events 3 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Gastrointestinal disorders Nausea	10.3% 4/39 • Number of events 4 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Musculoskeletal and connective tissue disorders Neck pain	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Musculoskeletal and connective tissue disorders Non-cardiac chest pain	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Ear and labyrinth disorders Otitis media	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
General disorders Pain	10.3% 4/39 • Number of events 4 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Musculoskeletal and connective tissue disorders Pain in extremity	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Skin and subcutaneous tissue disorders Pain of skin	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Cardiac disorders Palpitations	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Nervous system disorders Paresthesia	10.3% 4/39 • Number of events 4 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Reproductive system and breast disorders Perineal pain	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Nervous system disorders Peripheral sensory neuropathy	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Psychiatric disorders Personality change	7.7% 3/39 • Number of events 3 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Respiratory, thoracic and mediastinal disorders Productive cough	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Reproductive system and breast disorders Prostatic pain	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Skin and subcutaneous tissue disorders Pruritus	7.7% 3/39 • Number of events 3 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Psychiatric disorders Psychiatric disorders - Other, Mood changes	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Skin and subcutaneous tissue disorders Rash acneiform	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Skin and subcutaneous tissue disorders Rash maculo-papular	12.8% 5/39 • Number of events 6 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Renal and urinary disorders Renal calculi	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Psychiatric disorders Restlessness	7.7% 3/39 • Number of events 3 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Cardiac disorders Sinus bradycardia	15.4% 6/39 • Number of events 6 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Cardiac disorders Sinus tachycardia	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Skin and subcutaneous tissue disorders Skin induration	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Infections and infestations Skin infection	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Respiratory, thoracic and mediastinal disorders Sore throat	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Psychiatric disorders Suicidal ideation	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Nervous system disorders Syncope	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Reproductive system and breast disorders Testicular pain	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Ear and labyrinth disorders Tinnitus	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Infections and infestations Upper respiratory infection	17.9% 7/39 • Number of events 9 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Renal and urinary disorders Urinary frequency	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Renal and urinary disorders Urinary incontinence	25.6% 10/39 • Number of events 10 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Renal and urinary disorders Urinary retention	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Infections and infestations Urinary tract infection	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Renal and urinary disorders Urinary tract pain	5.1% 2/39 • Number of events 4 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Renal and urinary disorders Urinary urgency	12.8% 5/39 • Number of events 7 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Cardiac disorders Ventricular arrhythmia	7.7% 3/39 • Number of events 3 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Respiratory, thoracic and mediastinal disorders Voice alteration	5.1% 2/39 • Number of events 2 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Gastrointestinal disorders Vomiting	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Eye disorders Watering eyes	2.6% 1/39 • Number of events 1 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Investigations Weight gain	5.1% 2/39 • Number of events 4 • Date treatment consent signed to date off study, approximately 51 months and 2 days.
Investigations Weight loss	12.8% 5/39 • Number of events 5 • Date treatment consent signed to date off study, approximately 51 months and 2 days.

Additional Information

Dr. Fatima Karzai

National Cancer Institute

Phone: 301-480-7174

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place