Enzalutamide in Combination With PSA-TRICOM in Patients With Non-Metastatic Castration Sensitive Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01875250

Recruitment Status : Completed

First Posted : June 11, 2013

Results First Posted : September 16, 2020

Last Update Posted : September 16, 2020

Sponsor:

Information provided by (Responsible Party):

Ravi A. Madan, M.D., National Cancer Institute (NCI)

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Prostate Cancer
Interventions	Biological: PROSTVAC-F (Fowlpox)/TRICOM Biological: PROSTVAC-V (Vaccinia)/TRICOM Drug: Enzalutamide (Xtandi)
Enrollment	38

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Arm A - Enzalutamide for 3 Months	Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Arm/Group Description	Enzalutamide for 3 months ...	Enzalutamide 3 months + PSA-TRICOM ...
Arm/Group Description	Enzalutamide for 3 months Enzalutamide (Xtandi): An androgen receptor inhibitor.	Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21 PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide (Xtandi): An androgen receptor inhibitor.
Period Title: Overall Study
Started	19	19
Completed	17	19
Not Completed	2	0
Reason Not Completed
Adverse Event	2	0

Baseline Characteristics

Arm/Group Title		Arm A - Enzalutamide for 3 Months	Arm B - Enzalutamide for 3 Months + PSA-TRICOM	Total
Arm/Group Description		Enzalutamide for 3 months ...	Enzalutamide 3 months + PSA-TRICOM ...	Total of all reporting groups
Arm/Group Description		Enzalutamide for 3 months Enzalutamide (Xtandi): An androgen receptor inhibitor.	Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21 PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide (Xtandi): An androgen receptor inhibitor.	Total of all reporting groups
Overall Number of Baseline Participants		19	19	38
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	19 participants	19 participants	38 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	8 42.1%	12 63.2%	20 52.6%
	>=65 years	11 57.9%	7 36.8%	18 47.4%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	19 participants	19 participants	38 participants
		65.7 (8.46)	66.07 (5.29)	65.88 (6.87)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	19 participants	19 participants	38 participants
	Female	0 0.0%	0 0.0%	0 0.0%
	Male	19 100.0%	19 100.0%	38 100.0%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	19 participants	19 participants	38 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%
	Not Hispanic or Latino	19 100.0%	19 100.0%	38 100.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	19 participants	19 participants	38 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	4 21.1%	3 15.8%	7 18.4%
	White	15 78.9%	16 84.2%	31 81.6%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment Measure Type: Number Unit of measure: Participants
United States	Number Analyzed	19 participants	19 participants	38 participants
United States		19	19	38

Outcome Measures

1.Primary Outcome


Title	Tumor Growth Rate
Description	Growth rate was measured using the growth rate equation -f(t) = exp (-...
Description	Growth rate was measured using the growth rate equation -f(t) = exp (-dt) + exp (gt) -1 where exp is the base of the natural algorithm, e = 2.7182 and t is days since treatment started. The tumor growth rate equation measures Prostate Specific Antigen (PSA) rise over time. The UOM is unitless because this is a way to measure PSA kinetics.
Time Frame	7 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Arm A - Enzalutamide for 3 Months	Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Arm/Group Description:	Enzalutamide for 3 months ...	Enzalutamide 3 months + PSA-TRICOM ...
Arm/Group Description:	Enzalutamide for 3 months Enzalutamide (Xtandi): An androgen receptor inhibitor.	Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21 PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide (Xtandi): An androgen receptor inhibitor.
Overall Number of Participants Analyzed	19	19
Measure Type: Number Unit of Measure: unitless
	0.031	0.030

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A - Enzalutamide for 3 Months, Arm B - Enzalutamide for 3 Months + PSA-TRICOM
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.74
	Comments	[Not Specified]
	Method	Wilcoxon rank sum tests
	Comments	[Not Specified]

2.Secondary Outcome


Title	Mean Pretreatment Plasma Vascular Endothelial Growth Factor (VEGF) Concentration 30 Days After the Start of Course 1 and Course 2 of Enzalutamide
Description	VEGF was measured by the enzyme-linked immunosorbent assay (ELISA) ass...
Description	VEGF was measured by the enzyme-linked immunosorbent assay (ELISA) assay. The lower limit of quantitation of assay was 9.0 pg/ml.
Time Frame	30 Days After the Start of Course 1 and Course 2 of Enzalutamide

Outcome Measure Data

Analysis Population Description

It was pre-specified to combine analysis for Arms of growth factors.


Arm/Group Title	All Participants
Arm/Group Description:	All participants who received Enzal...
Arm/Group Description:	All participants who received Enzalutamide for 3 months and Enzalutamide 3 months + PSA-TRICOM.
Overall Number of Participants Analyzed	36
Mean (Standard Deviation) Unit of Measure: pg/ml
Course 1	192 (82)
Course 2	165.04 (82.38)

3.Secondary Outcome


Title	Median Testosterone After 84 Days of Enzalutamide
Description	Normal testosterone is 270-1070 nd/dL.
Description	Normal testosterone is 270-1070 nd/dL.
Time Frame	84 days

Outcome Measure Data

Analysis Population Description

It was pre-specified to combine analysis for testosterone. In addition, data was not analyzed beyond Course 1 because it was not part of the initial statistical plan.


Arm/Group Title	All Participants
Arm/Group Description:	All participants who received Enzal...
Arm/Group Description:	All participants who received Enzalutamide for 3 months and Enzalutamide 3 months + PSA-TRICOM,
Overall Number of Participants Analyzed	36
Median (Full Range) Unit of Measure: ng/dl
	834 (308 to 1579)

4.Secondary Outcome


Title	Percent Change in Prostate Specific Antigen (PSA) After 84 Days of Enzalutamide in Course 1
Description	Median PSA change would be considered optimal.
Description	Median PSA change would be considered optimal.
Time Frame	84 days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Arm A - Enzalutamide for 3 Months	Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Arm/Group Description:	Enzalutamide for 3 months ...	Enzalutamide 3 months + PSA-TRICOM ...
Arm/Group Description:	Enzalutamide for 3 months Enzalutamide (Xtandi): An androgen receptor inhibitor.	Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21 PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide (Xtandi): An androgen receptor inhibitor.
Overall Number of Participants Analyzed	19	19
Median (Full Range) Unit of Measure: Percent change
	-99 (-84 to -99)	-99 (-87 to -99)

5.Secondary Outcome


Title	Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
Description	Here is the count of participants with serious and non-serious adverse...
Description	Here is the count 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.
Time Frame	Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Arm A - Enzalutamide for 3 Months	Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Arm/Group Description:	Enzalutamide for 3 months ...	Enzalutamide 3 months + PSA-TRICOM ...
Arm/Group Description:	Enzalutamide for 3 months Enzalutamide (Xtandi): An androgen receptor inhibitor.	Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21 PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide (Xtandi): An androgen receptor inhibitor.
Overall Number of Participants Analyzed	19	19
Measure Type: Count of Participants Unit of Measure: Participants
	19 100.0%	19 100.0%

6.Secondary Outcome


Title	Median Time Until Prostate Specific Antigen (PSA) Recovery From Baseline Following Course 1 and Course 2 of Enzalutamide
Description	PSA recovery is defined as the return above baseline PSA in participan...
Description	PSA recovery is defined as the return above baseline PSA in participants with normal testosterone and non-metastatic, castration sensitive prostate cancer.
Time Frame	up to 41 months

Outcome Measure Data

Analysis Population Description

It was pre-specified to combine analysis for Arms of PSA Recovery time.


Arm/Group Title	All Participants
Arm/Group Description:	All participants who received Enzal...
Arm/Group Description:	All participants who received Enzalutamide for 3 months and Enzalutamide 3 months + PSA-TRICOM.
Overall Number of Participants Analyzed	36
Median (Full Range) Unit of Measure: Days
Course 1	224 (84 to 1246)
Course 2	189 (78 to 400)

Adverse Events

Time Frame	Date treatment consent signed to date off study, approximately 43 months and 13 days for Arm A, and 78 months and 6 days for Arm B.
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Arm A - Enzalutamide for 3 Months		Arm B - Enzalutamide for 3 Months + PSA-TRICOM
Arm/Group Description	Enzalutamide for 3 months ...		Enzalutamide 3 months + PSA-TRICOM ...
Arm/Group Description	Enzalutamide for 3 months Enzalutamide (Xtandi): An androgen receptor inhibitor.		Enzalutamide 3 months + PSA-TRICOM (Prostvac-V/F) on weeks 1, 3, 5, 9,13,17 and 21 PROSTVAC-F (Fowlpox)/TRICOM: A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules. PROSTVAC-V (Vaccinia)/TRICOM: A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules. Enzalutamide (Xtandi): An androgen receptor inhibitor.
All-Cause Mortality
	Arm A - Enzalutamide for 3 Months		Arm B - Enzalutamide for 3 Months + PSA-TRICOM
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/19 (0.00%)		0/19 (0.00%)
Serious Adverse Events Serious Adverse Events
	Arm A - Enzalutamide for 3 Months		Arm B - Enzalutamide for 3 Months + PSA-TRICOM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0.00%)		1/19 (5.26%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify ^† 1 [1]	0/19 (0.00%)	0	1/19 (5.26%)	1
1 Term from vocabulary, CTCAE (4.0) † Indicates events were collected by systematic assessment [1] Surgical biopsy 1/5 and 6 weeks of radiation scheduled to start January 2017.
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Arm A - Enzalutamide for 3 Months		Arm B - Enzalutamide for 3 Months + PSA-TRICOM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/19 (100.00%)		19/19 (100.00%)
Blood and lymphatic system disorders
Anemia ^† 1	5/19 (26.32%)	6	8/19 (42.11%)	11
Blood and lymphatic system disorders - Other, specify ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Thrombotic thrombocytopenic purpura ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Cardiac disorders
Atrial fibrillation ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Cardiac disorders - Other, specify ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Chest pain - cardiac ^† 1	1/19 (5.26%)	1	1/19 (5.26%)	1
Palpitations ^† 1	0/19 (0.00%)	0	2/19 (10.53%)	2
Ear and labyrinth disorders
Ear pain ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Eye disorders
Blurred vision ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Cataract ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Eye disorders - Other, Diplopia Lightheadedness intermittent ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Eye disorders - Other, Tearfullness ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Flashing lights ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Gastrointestinal disorders
Abdominal pain ^† 1	1/19 (5.26%)	1	1/19 (5.26%)	2
Bloating ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Constipation ^† 1	1/19 (5.26%)	2	5/19 (26.32%)	6
Diarrhea ^† 1	3/19 (15.79%)	3	5/19 (26.32%)	5
Dry mouth ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Dysphagia ^† 1	1/19 (5.26%)	1	1/19 (5.26%)	1
Esophageal obstruction ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Gastroesophageal reflux disease ^† 1	1/19 (5.26%)	1	1/19 (5.26%)	2
Gastrointestinal disorders - Other, Damaged broken tooth ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Gastrointestinal disorders - Other, Reflux ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Mucositis oral ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Nausea ^† 1	7/19 (36.84%)	8	4/19 (21.05%)	7
Rectal hemorrhage ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Stomach pain ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Toothache ^† 1	0/19 (0.00%)	0	2/19 (10.53%)	2
Vomiting ^† 1	2/19 (10.53%)	2	2/19 (10.53%)	3
General disorders
Chills ^† 1	2/19 (10.53%)	2	3/19 (15.79%)	7
Edema limbs ^† 1	5/19 (26.32%)	6	2/19 (10.53%)	2
Fatigue ^† 1	16/19 (84.21%)	26	16/19 (84.21%)	28
Fever ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	3
Flatulence ^† 1	1/19 (5.26%)	1	1/19 (5.26%)	1
Flu like symptoms ^† 1	1/19 (5.26%)	1	6/19 (31.58%)	7
Injection site reaction ^† 1	0/19 (0.00%)	0	18/19 (94.74%)	70
Pain ^† 1	4/19 (21.05%)	6	5/19 (26.32%)	7
Immune system disorders
Autoimmune disorder ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Infections and infestations
Bronchial infection ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Eye infection ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Gum infection ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Infections and infestations - Diverticulitis-received 2 antibiotics ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Infections and infestations - Other, Flu 2-3 weeks ago, ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Infections and infestations - Other, No antibiotics ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Infections and infestations - Other, URI and rash ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Infections and infestations - Other, URI-head cold, uses Dayquil ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Infections and infestations - Other, UTI ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Infections and infestations - Other, Viral infection ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Infections and infestations - Other, Wound infection ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Infections and infestations - Other, Cold ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Infections and infestations - Other, Cold- OTC meds ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Infections and infestations - Other, Erythema ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Infections and infestations - Other, Fungal infection-Terbinafine ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Infections and infestations - Other, URI- no antibiotics ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Lip infection ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Rhinitis infective ^† 1	1/19 (5.26%)	1	1/19 (5.26%)	1
Sinusitis ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Upper respiratory infection ^† 1	3/19 (15.79%)	3	5/19 (26.32%)	5
Injury, poisoning and procedural complications
Fall ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Fracture ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Injury, poisoning and procedural complications - Other, specify ^† 1	0/19 (0.00%)	0	2/19 (10.53%)	2
Investigations
Alanine aminotransferase increased ^† 1	5/19 (26.32%)	9	5/19 (26.32%)	8
Aspartate aminotransferase increased ^† 1	3/19 (15.79%)	6	2/19 (10.53%)	6
Blood bilirubin increased ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
CPK increased ^† 1	4/19 (21.05%)	10	4/19 (21.05%)	5
Cholesterol high ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Creatinine increased ^† 1	2/19 (10.53%)	2	2/19 (10.53%)	2
Lymphocyte count decreased ^† 1	7/19 (36.84%)	15	8/19 (42.11%)	22
Neutrophil count decreased ^† 1	1/19 (5.26%)	3	2/19 (10.53%)	4
Platelet count decreased ^† 1	2/19 (10.53%)	2	4/19 (21.05%)	9
Weight gain ^† 1	1/19 (5.26%)	1	1/19 (5.26%)	1
Weight loss ^† 1	1/19 (5.26%)	1	2/19 (10.53%)	2
White blood cell decreased ^† 1	5/19 (26.32%)	9	8/19 (42.11%)	12
Metabolism and nutrition disorders
Anorexia ^† 1	3/19 (15.79%)	4	4/19 (21.05%)	5
Hypercalcemia ^† 1	1/19 (5.26%)	1	2/19 (10.53%)	3
Hyperglycemia ^† 1	9/19 (47.37%)	26	8/19 (42.11%)	14
Hyperkalemia ^† 1	1/19 (5.26%)	1	1/19 (5.26%)	2
Hypernatremia ^† 1	4/19 (21.05%)	6	3/19 (15.79%)	3
Hypoalbuminemia ^† 1	1/19 (5.26%)	3	2/19 (10.53%)	3
Hypocalcemia ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	2
Hypoglycemia ^† 1	2/19 (10.53%)	3	2/19 (10.53%)	3
Hypokalemia ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Hyponatremia ^† 1	3/19 (15.79%)	3	2/19 (10.53%)	3
Hypophosphatemia ^† 1	9/19 (47.37%)	26	7/19 (36.84%)	24
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/19 (5.26%)	1	1/19 (5.26%)	1
Back pain ^† 1	4/19 (21.05%)	4	8/19 (42.11%)	12
Buttock pain ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Joint range of motion decreased ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Muscle weakness lower limb ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Muscle weakness upper limb ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Musculoskeletal and connective tissue disorder - Other, specify ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Myalgia ^† 1	3/19 (15.79%)	3	7/19 (36.84%)	7
Neck pain ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Pain in extremity ^† 1	2/19 (10.53%)	2	2/19 (10.53%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Nervous system disorders
Concentration impairment ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Depressed level of consciousness ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	2
Dizziness ^† 1	5/19 (26.32%)	10	5/19 (26.32%)	7
Dysgeusia ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Facial nerve disorder ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	2
Headache ^† 1	2/19 (10.53%)	2	6/19 (31.58%)	13
Lethargy ^† 1	3/19 (15.79%)	4	4/19 (21.05%)	4
Memory impairment ^† 1	1/19 (5.26%)	1	3/19 (15.79%)	3
Nervous system disorders - Other, specify ^† 1	1/19 (5.26%)	2	0/19 (0.00%)	0
Paresthesia ^† 1	1/19 (5.26%)	1	2/19 (10.53%)	2
Peripheral sensory neuropathy ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Somnolence ^† 1	1/19 (5.26%)	1	1/19 (5.26%)	1
Tremor ^† 1	0/19 (0.00%)	0	2/19 (10.53%)	2
Psychiatric disorders
Anxiety ^† 1	1/19 (5.26%)	2	3/19 (15.79%)	3
Depression ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Insomnia ^† 1	1/19 (5.26%)	2	3/19 (15.79%)	3
Renal and urinary disorders
Hematuria ^† 1	1/19 (5.26%)	1	3/19 (15.79%)	3
Hemoglobinuria ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Urinary frequency ^† 1	3/19 (15.79%)	3	6/19 (31.58%)	6
Urinary incontinence ^† 1	0/19 (0.00%)	0	2/19 (10.53%)	2
Urinary retention ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Urinary tract obstruction ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Urinary tract pain ^† 1	1/19 (5.26%)	1	1/19 (5.26%)	1
Urine discoloration ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Reproductive system and breast disorders
Breast atrophy ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Breast pain ^† 1	15/19 (78.95%)	19	16/19 (84.21%)	21
Erectile dysfunction ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Gynecomastia ^† 1	9/19 (47.37%)	13	7/19 (36.84%)	8
Libido decreased ^† 1	1/19 (5.26%)	1	3/19 (15.79%)	4
Nipple deformity ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis ^† 1	3/19 (15.79%)	3	2/19 (10.53%)	2
Cough ^† 1	4/19 (21.05%)	5	2/19 (10.53%)	2
Hoarseness ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Nasal congestion ^† 1	2/19 (10.53%)	2	1/19 (5.26%)	1
Pharyngolaryngeal pain ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Respiratory, thoracic and mediastinal disorders - Other, specify ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Sneezing ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Sore throat ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Voice alteration ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Skin and subcutaneous tissue disorders
Dermatitis radiation ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Dry skin ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Erythema multiforme ^† 1	0/19 (0.00%)	0	2/19 (10.53%)	2
Pruritus ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Rash acneiform ^† 1	1/19 (5.26%)	2	0/19 (0.00%)	0
Rash maculo-papular ^† 1	1/19 (5.26%)	2	2/19 (10.53%)	3
Skin and subcutaneous tissue disorders - Other, Dry skin ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Skin and subcutaneous tissue disorders - Other, Fullness B/L in temporal area-not painful ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Skin and subcutaneous tissue disorders - Other, Pre cancerous lesion ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Skin and subcutaneous tissue disorders - Other, Sores on feet ^† 1	1/19 (5.26%)	1	0/19 (0.00%)	0
Skin and subcutaneous tissue disorders - Other, Abraasion ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Skin and subcutaneous tissue disorders - Other, Allergic reaction ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Skin and subcutaneous tissue disorders - Other, Callus ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Skin and subcutaneous tissue disorders - Other, Cold sore ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	2
Skin and subcutaneous tissue disorders - Other, Dry skin ^† 1	0/19 (0.00%)	0	1/19 (5.26%)	1
Vascular disorders
Hot flashes ^† 1	3/19 (15.79%)	4	3/19 (15.79%)	4
Hypertension ^† 1	2/19 (10.53%)	2	1/19 (5.26%)	1
Hypotension ^† 1	1/19 (5.26%)	1	1/19 (5.26%)	1
1 Term from vocabulary, CTCAE (4.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Dr. Ravi A. Madan
Organization:	National Cancer Institute
Phone:	301-480-7168
EMail:	m480i@nih.gov

Publications:

Furr BJ. "Casodex" (ICI 176,334)--a new, pure, peripherally-selective anti-androgen: preclinical studies. Horm Res. 1989;32 Suppl 1:69-76.

Chen Y, Clegg NJ, Scher HI. Anti-androgens and androgen-depleting therapies in prostate cancer: new agents for an established target. Lancet Oncol. 2009 Oct;10(10):981-91. doi: 10.1016/S1470-2045(09)70229-3.

Sartor AO, Tangen CM, Hussain MH, Eisenberger MA, Parab M, Fontana JA, Chapman RA, Mills GM, Raghavan D, Crawford ED; Southwest Oncology Group. Antiandrogen withdrawal in castrate-refractory prostate cancer: a Southwest Oncology Group trial (SWOG 9426). Cancer. 2008 Jun;112(11):2393-400. doi: 10.1002/cncr.23473.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Madan RA, Karzai F, Donahue RN, Al-Harthy M, Bilusic M, Rosner II, Singh H, Arlen PM, Theoret MR, Marté JL, Cordes L, Couvillon A, Hankin A, Williams M, Owens H, Lochrin SE, Chau CH, Steinberg S, Figg WD, Dahut W, Schlom J, Gulley JL. Clinical and immunologic impact of short-course enzalutamide alone and with immunotherapy in non-metastatic castration sensitive prostate cancer. J Immunother Cancer. 2021 Mar;9(3). pii: e001556. doi: 10.1136/jitc-2020-001556.

Layout table for additonal information

Responsible Party:	Ravi A. Madan, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT01875250
Other Study ID Numbers:	130153 13-C-0153
First Submitted:	June 7, 2013
First Posted:	June 11, 2013
Results First Submitted:	August 13, 2020
Results First Posted:	September 16, 2020
Last Update Posted:	September 16, 2020

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