Trial Outcomes & Findings for Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer (NCT NCT02064582)
NCT ID: NCT02064582
Last Updated: 2020-10-12
Results Overview
Assessment will number of participants who experience adverse events greater than or equal to Grade 3, as defined by NCI Common terminology criteria for adverse events(CTCAE) v4.0
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
12 months following initiation of treatment with enzalutamide plus GnRH agonist
Results posted on
2020-10-12
Participant Flow
7 met criteria and were enrolled in the trial
Participant milestones
| Measure |
Enzalutamide, Leuprolide, Radiation
Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care
Enzalutamide: 160mg by mouth each day
Leuprolide acetate: 22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months
radiation: External beam radiation will be delivered as per standard radiation therapy protocol
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer
Baseline characteristics by cohort
| Measure |
Enzalutamide, Leuprolide, Radiation
n=7 Participants
Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care
Enzalutamide: 160mg by mouth each day
Leuprolide acetate: 22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months
radiation: External beam radiation will be delivered as per standard radiation therapy protocol
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months following initiation of treatment with enzalutamide plus GnRH agonistAssessment will number of participants who experience adverse events greater than or equal to Grade 3, as defined by NCI Common terminology criteria for adverse events(CTCAE) v4.0
Outcome measures
| Measure |
Enzalutamide, Leuprolide, Radiation
n=7 Participants
Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care
Enzalutamide: 160mg by mouth each day
Leuprolide acetate: 22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months
radiation: External beam radiation will be delivered as per standard radiation therapy protocol
|
|---|---|
|
Safety, as Measured by the Number of Patients With at Least One Adverse Event as Assess by NCI Common Terminology Criteria for Adverse Events (CTCAE) vs. 40 When Combining Enzalutamide With a GnRH and External Beam Radiation
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsFold change of Intra-tumoral Androgen Regulated Gene Expression (PSA, FKBP5, TMPRSS2, and NDRG1) will be measure at 12 months post therapy.
Outcome measures
| Measure |
Enzalutamide, Leuprolide, Radiation
n=7 Participants
Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care
Enzalutamide: 160mg by mouth each day
Leuprolide acetate: 22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months
radiation: External beam radiation will be delivered as per standard radiation therapy protocol
|
|---|---|
|
Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy
Fold change in PSA
|
0.54 Fold change
Interval 0.16 to 21.0
|
|
Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy
Fold change in FKBP5
|
2.2 Fold change
Interval 0.72 to 22.15
|
|
Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy
Fold change in TMPRSS2
|
0.65 Fold change
Interval 0.17 to 3.3
|
|
Fold Change in Intra-tumoral Androgen Regulated Gene Expression Pre and Post Combination Therapy
Fold change in NDRG1
|
0.36 Fold change
Interval 0.0 to 7.53
|
Adverse Events
Enzalutamide, Leuprolide, Radiation
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Enzalutamide, Leuprolide, Radiation
n=7 participants at risk
Single arm Enzalutamide 160 mg daily for 6 months Leuprolide acetate 22.5mg every 3 months or 45mg every 6 months Radiation therapy as standard of care
Enzalutamide: 160mg by mouth each day
Leuprolide acetate: 22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months
radiation: External beam radiation will be delivered as per standard radiation therapy protocol
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain / bloating
|
57.1%
4/7 • Number of events 4 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Vascular disorders
Aneurysm internal iliac artery
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Psychiatric disorders
Anxiety / depression
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Musculoskeletal and connective tissue disorders
Lower extremity edema
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Eye disorders
Blurred vision
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Gastrointestinal disorders
constipation
|
57.1%
4/7 • Number of events 4 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
fatigue
|
85.7%
6/7 • Number of events 6 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
hot flashes / night sweats
|
100.0%
7/7 • Number of events 8 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Gastrointestinal disorders
Diarrhea / loose stools
|
57.1%
4/7 • Number of events 7 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Gastrointestinal disorders
Heartburn
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Dizziness
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
85.7%
6/7 • Number of events 6 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Bone metastasis
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Cardiac disorders
Bruit of left carotid artery
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Eye disorders
Cataract, both eyes
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Change in mole on neck
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Skin and subcutaneous tissue disorders
Clammy skin, oiliness, filminess skin/teeth
|
14.3%
1/7 • Number of events 2 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Chest pain
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Lower back pain
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Eye disorders
Color perception changes
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Skin and subcutaneous tissue disorders
Neuropathy
|
71.4%
5/7 • Number of events 5 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Decrease in energy
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Eye disorders
Decreased night vision
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Psychiatric disorders
Emotional depression/insomina
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Erectile dysfunction
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Fall
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Folliculitis
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Frontal headaches
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Ear and labyrinth disorders
Hearing loss
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Gastrointestinal disorders
Hematochezia
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Renal and urinary disorders
Noctoria
|
42.9%
3/7 • Number of events 4 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Renal and urinary disorders
burning on urination
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Nausea
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Hoarseness/ fullness in throat
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Cardiac disorders
Hypertension
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Weight gain
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Hot flashes with sweating/night sweats
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Endocrine disorders
Hyperglycemia
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Vivid dreams
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Increased hunger
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Renal and urinary disorders
Urethral pain/ dysuria
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Renal and urinary disorders
Urinary dribbling
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Renal and urinary disorders
Urinary frequency
|
57.1%
4/7 • Number of events 4 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Lightheadedness
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Loss of smell
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Musculoskeletal and connective tissue disorders
Bone / joint pain
|
100.0%
7/7 • Number of events 7 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Skin and subcutaneous tissue disorders
Left pectoralis skin lesion bx squamous cell
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Hepatobiliary disorders
Transaminitis
|
42.9%
3/7 • Number of events 3 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Musculoskeletal and connective tissue disorders
Morning Stiffness/ arthralgia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Internal tension
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Memory loss
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Musculoskeletal and connective tissue disorders
Muscle pull left wrist
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Blood and lymphatic system disorders
Adenopathy
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Pelvic pain/prostate/ inguinal
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Skin and subcutaneous tissue disorders
Rash
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Metabolism and nutrition disorders
Poor appetite
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Surgical and medical procedures
Radiation proctitis
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Rectal burning / irritation
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Recurrence of claudication in setting of PVD
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Right breast tenderness and swelling
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Short term memory impairment
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
28.6%
2/7 • Number of events 2 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Endocrine disorders
Ringing in ears
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Seasonal Allergies
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Spontaneous passage of kidney stone
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Stress Incontinence
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
Infections and infestations
Upper respiratory infection
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
|
General disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • Adverse events were collected from time of consent and ended 30 days post medication, an average of one year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place