Trial Outcomes & Findings for Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM) (NCT NCT02057939)
NCT ID: NCT02057939
Last Updated: 2019-06-26
Results Overview
Percentage of patients surviving 2 years from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks OR evidence of clinical progression or initiation of systemic therapy for progressive disease
COMPLETED
PHASE2
38 participants
2 years
2019-06-26
Participant Flow
Participant milestones
| Measure |
Enzalutamide
Enzalutamide, Androgen Deprivation, and Radiation Therapy
enzalutamide: 160 mg orally once daily for six months
Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.
Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy
|
|---|---|
|
Overall Study
STARTED
|
38
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Salvage Therapeutic Radiation With Enzalutamide and ADT in Men With Recurrent Prostate Cancer (STREAM)
Baseline characteristics by cohort
| Measure |
Enzalutamide
n=38 Participants
Enzalutamide, Androgen Deprivation, and Radiation Therapy
enzalutamide: 160 mg orally once daily for six months
Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.
Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy
|
|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 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
|
1 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
|
34 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
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses.
Percentage of patients surviving 2 years from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks OR evidence of clinical progression or initiation of systemic therapy for progressive disease
Outcome measures
| Measure |
Enzalutamide
n=37 Participants
Enzalutamide, Androgen Deprivation, and Radiation Therapy
enzalutamide: 160 mg orally once daily for six months
Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.
Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy
|
|---|---|
|
Two Year Progression-free Survival
|
64.9 percentage
Interval 47.3 to 77.9
|
SECONDARY outcome
Timeframe: every year, up to 3 yearsPopulation: One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses. Note that 11 patients did not have PSA measurements at 2 years and 24 did not have PSA measurements at 3 years. They are still included in the denominator.
The percentage of men with PSA less than 0.1 ng/mL and testosterone greater than 100
Outcome measures
| Measure |
Enzalutamide
n=37 Participants
Enzalutamide, Androgen Deprivation, and Radiation Therapy
enzalutamide: 160 mg orally once daily for six months
Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.
Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy
|
|---|---|
|
PSA Less Than 0.1
1 year
|
75.7 percentage
|
|
PSA Less Than 0.1
2 year
|
48.6 percentage
|
|
PSA Less Than 0.1
3 year
|
32.4 percentage
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses.
Percentage of patients surviving 3 years from the start of study treatment without progression of disease. PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks OR evidence of clinical progression or initiation of systemic therapy for progressive disease
Outcome measures
| Measure |
Enzalutamide
n=37 Participants
Enzalutamide, Androgen Deprivation, and Radiation Therapy
enzalutamide: 160 mg orally once daily for six months
Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.
Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy
|
|---|---|
|
Three Year Progression-free Survival
|
53.2 percentage
Interval 35.9 to 67.9
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses.
Percentage of patients surviving 2 and 3 years from the start of study treatment without progression of disease. Biochemical PFS was defined as the time from the date of study treatment initiation to the date of first documented progression or death due to any cause. Progression-free was defined as being without one of the following: serum PSA value of 0.2 ng/mL or more above post-radiotherapy PSA nadir that continues to increase 4 weeks later OR if no nadir is experienced, two rising PSA values over 4 or more weeks
Outcome measures
| Measure |
Enzalutamide
n=37 Participants
Enzalutamide, Androgen Deprivation, and Radiation Therapy
enzalutamide: 160 mg orally once daily for six months
Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.
Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy
|
|---|---|
|
Biochemical Progression-free Survival
2 year bPFS
|
64.9 percentage
Interval 47.3 to 77.9
|
|
Biochemical Progression-free Survival
3 year bPFS
|
53.2 percentage
Interval 35.9 to 67.9
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses.
Median PSA nadir post-radiation therapy
Outcome measures
| Measure |
Enzalutamide
n=37 Participants
Enzalutamide, Androgen Deprivation, and Radiation Therapy
enzalutamide: 160 mg orally once daily for six months
Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.
Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy
|
|---|---|
|
PSA Nadir
|
0 ng/ml
Interval 0.0 to 0.1
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: One patient did not receive radiotherapy due to continual scar tissue development surrounding the ureters. This patient is not considered for analyses.
Percentage of patients with recovering testosterone to \> 100 at 1, 2, and 3 years.
Outcome measures
| Measure |
Enzalutamide
n=37 Participants
Enzalutamide, Androgen Deprivation, and Radiation Therapy
enzalutamide: 160 mg orally once daily for six months
Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.
Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy
|
|---|---|
|
Time to Testosterone Recovery
1 year
|
94.6 percentage
|
|
Time to Testosterone Recovery
2 year
|
100 percentage
|
|
Time to Testosterone Recovery
3 year
|
100 percentage
|
SECONDARY outcome
Timeframe: 3 yearsSafety and tolerability will be assessed using CTCAE v4.0
Outcome measures
| Measure |
Enzalutamide
n=38 Participants
Enzalutamide, Androgen Deprivation, and Radiation Therapy
enzalutamide: 160 mg orally once daily for six months
Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.
Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy
|
|---|---|
|
Number of Patients With Adverse Events Related to Combination Enzalutamide, ADT, and XRT
|
36 participants
|
Adverse Events
Enzalutamide
Serious adverse events
| Measure |
Enzalutamide
n=38 participants at risk
Enzalutamide, Androgen Deprivation, and Radiation Therapy
enzalutamide: 160 mg orally once daily for six months
Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.
Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
2.6%
1/38 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other, Specify: BLADDER
|
2.6%
1/38 • 3 years
|
|
Renal and urinary disorders
Urinary retention
|
2.6%
1/38 • 3 years
|
Other adverse events
| Measure |
Enzalutamide
n=38 participants at risk
Enzalutamide, Androgen Deprivation, and Radiation Therapy
enzalutamide: 160 mg orally once daily for six months
Androgen Deprivation: Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.
Radiation Therapy: Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy
|
|---|---|
|
Renal and urinary disorders
Cystitis noninfective
|
2.6%
1/38 • 3 years
|
|
Renal and urinary disorders
Hematuria
|
2.6%
1/38 • 3 years
|
|
Renal and urinary disorders
Other, Specify: NOCTURIA
|
5.3%
2/38 • 3 years
|
|
Renal and urinary disorders
Other, Specify: NOCTURIA, RELATED TO RADIATION
|
2.6%
1/38 • 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
28.9%
11/38 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
23.7%
9/38 • 3 years
|
|
Cardiac disorders
Acute coronary syndrome
|
2.6%
1/38 • 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
2.6%
1/38 • 3 years
|
|
Ear and labyrinth disorders
Other, Specify: EAR PRESSURE
|
2.6%
1/38 • 3 years
|
|
Ear and labyrinth disorders
Tinnitus
|
2.6%
1/38 • 3 years
|
|
Ear and labyrinth disorders
Vertigo
|
2.6%
1/38 • 3 years
|
|
Eye disorders
Blurred vision
|
2.6%
1/38 • 3 years
|
|
Eye disorders
Other, Specify: FLOATERS
|
2.6%
1/38 • 3 years
|
|
Eye disorders
Other, Specify: PSUEDOPHAKIA
|
2.6%
1/38 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
1/38 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
18.4%
7/38 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
34.2%
13/38 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
5.3%
2/38 • 3 years
|
|
Gastrointestinal disorders
Flatulence
|
2.6%
1/38 • 3 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
2.6%
1/38 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
15.8%
6/38 • 3 years
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
2.6%
1/38 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/38 • 3 years
|
|
General disorders
Edema limbs
|
2.6%
1/38 • 3 years
|
|
General disorders
Fatigue
|
78.9%
30/38 • 3 years
|
|
General disorders
Fever
|
2.6%
1/38 • 3 years
|
|
General disorders
Gait disturbance
|
2.6%
1/38 • 3 years
|
|
General disorders
Injection site reaction
|
2.6%
1/38 • 3 years
|
|
General disorders
Irritability
|
2.6%
1/38 • 3 years
|
|
General disorders
Malaise
|
2.6%
1/38 • 3 years
|
|
General disorders
Non-cardiac chest pain
|
2.6%
1/38 • 3 years
|
|
General disorders
Pain
|
15.8%
6/38 • 3 years
|
|
Infections and infestations
Bronchial infection
|
2.6%
1/38 • 3 years
|
|
Infections and infestations
Other, Specify: COMMON COLD
|
2.6%
1/38 • 3 years
|
|
Infections and infestations
Other, Specify: TICK BITE WITH FEVER, CHILLS, BODY ACHES, HEADACHES
|
2.6%
1/38 • 3 years
|
|
Infections and infestations
Papulopustular rash
|
2.6%
1/38 • 3 years
|
|
Infections and infestations
Skin infection
|
7.9%
3/38 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
2.6%
1/38 • 3 years
|
|
Investigations
Alanine aminotransferase increased
|
7.9%
3/38 • 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
1/38 • 3 years
|
|
Investigations
Blood bilirubin increased
|
5.3%
2/38 • 3 years
|
|
Investigations
Cardiac troponin I increased
|
2.6%
1/38 • 3 years
|
|
Investigations
Lymphocyte count decreased
|
18.4%
7/38 • 3 years
|
|
Investigations
Platelet count decreased
|
2.6%
1/38 • 3 years
|
|
Investigations
Weight gain
|
5.3%
2/38 • 3 years
|
|
Investigations
Weight loss
|
5.3%
2/38 • 3 years
|
|
Investigations
White blood cell decreased
|
15.8%
6/38 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
5.3%
2/38 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.2%
5/38 • 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.6%
1/38 • 3 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.6%
1/38 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.6%
1/38 • 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.6%
1/38 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.6%
1/38 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
2.6%
1/38 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.9%
3/38 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.9%
3/38 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.6%
1/38 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
4/38 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.6%
1/38 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.6%
1/38 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.6%
1/38 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Other, Specify
|
2.6%
1/38 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.6%
1/38 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
13.2%
5/38 • 3 years
|
|
Nervous system disorders
Akathisia
|
2.6%
1/38 • 3 years
|
|
Nervous system disorders
Dizziness
|
7.9%
3/38 • 3 years
|
|
Nervous system disorders
Dysesthesia
|
2.6%
1/38 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
18.4%
7/38 • 3 years
|
|
Nervous system disorders
Headache
|
18.4%
7/38 • 3 years
|
|
Nervous system disorders
Memory impairment
|
13.2%
5/38 • 3 years
|
|
Nervous system disorders
Movements involuntary
|
2.6%
1/38 • 3 years
|
|
Nervous system disorders
Other, Specify: RESTLESS LEG SYNDROME
|
2.6%
1/38 • 3 years
|
|
Nervous system disorders
Other, Specify: RESTLESS LEGS
|
13.2%
5/38 • 3 years
|
|
Nervous system disorders
Other, Specify: RESTLESS LEGS; INTERMITTENT/AT NIGHT
|
2.6%
1/38 • 3 years
|
|
Nervous system disorders
Other, Specify: VIVID DREAMS
|
5.3%
2/38 • 3 years
|
|
Nervous system disorders
Paresthesia
|
5.3%
2/38 • 3 years
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.6%
1/38 • 3 years
|
|
Nervous system disorders
Tremor
|
2.6%
1/38 • 3 years
|
|
Nervous system disorders
Vasovagal reaction
|
2.6%
1/38 • 3 years
|
|
Psychiatric disorders
Anxiety
|
10.5%
4/38 • 3 years
|
|
Psychiatric disorders
Depression
|
5.3%
2/38 • 3 years
|
|
Psychiatric disorders
Insomnia
|
39.5%
15/38 • 3 years
|
|
Psychiatric disorders
Libido decreased
|
7.9%
3/38 • 3 years
|
|
Psychiatric disorders
Personality change
|
5.3%
2/38 • 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
2.6%
1/38 • 3 years
|
|
Renal and urinary disorders
Urinary retention
|
10.5%
4/38 • 3 years
|
|
Renal and urinary disorders
Urinary tract pain
|
2.6%
1/38 • 3 years
|
|
Renal and urinary disorders
Urinary urgency
|
13.2%
5/38 • 3 years
|
|
Reproductive system and breast disorders
Breast pain
|
2.6%
1/38 • 3 years
|
|
Reproductive system and breast disorders
Gynecomastia
|
5.3%
2/38 • 3 years
|
|
Reproductive system and breast disorders
Testicular pain
|
2.6%
1/38 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.6%
1/38 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
4/38 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.5%
4/38 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.9%
3/38 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
13.2%
5/38 • 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.9%
3/38 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
2.6%
1/38 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.3%
2/38 • 3 years
|
|
Skin and subcutaneous tissue disorders
Other, Specify: A LUMP JUST ABOVE ANTECUBITAL SPACE OF LEFT ARM
|
2.6%
1/38 • 3 years
|
|
Skin and subcutaneous tissue disorders
Other, Specify: ABRASION WITH EDEMA, LEFT ANKLE, DUE TO TRAUMA TO LEFT LEG
|
2.6%
1/38 • 3 years
|
|
Skin and subcutaneous tissue disorders
Other, Specify: ECZEMA BILATERAL ELBOWS AND LEFT SHIN
|
2.6%
1/38 • 3 years
|
|
Skin and subcutaneous tissue disorders
Other, Specify: ONE SPOT ON EACH ARM
|
2.6%
1/38 • 3 years
|
|
Skin and subcutaneous tissue disorders
Other, Specify: SKIN IRRITATION
|
2.6%
1/38 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
5.3%
2/38 • 3 years
|
|
Surgical and medical procedures
Other, Specify: MOHS SURGERY FOR BASAL CELL
|
2.6%
1/38 • 3 years
|
|
Surgical and medical procedures
Other, Specify: RECTAL IRRITATION, RELATED TO RADIATION
|
2.6%
1/38 • 3 years
|
|
Vascular disorders
Hot flashes
|
73.7%
28/38 • 3 years
|
|
Vascular disorders
Hypertension
|
18.4%
7/38 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place