Trial Outcomes & Findings for AASUR in High Risk Prostate Cancer (NCT NCT02772588)
NCT ID: NCT02772588
Last Updated: 2026-04-13
Results Overview
Biochemical failure is defined as an increase in PSA by more than 2ng/mL above the nadir value. PSA rise equals or exceeds 2ng/mL will be the date of failure.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
36 months
Results posted on
2026-04-13
Participant Flow
Participant milestones
| Measure |
Patients With Prostate Cancer
Eligible patients will receive a total of 6 months of leuprolide, abiraterone, and ARN-509 to begin three months prior to RT and continuing until approximately 3 months post-RT. Patients will be assessed every 4 weeks (±1 week) (a cycle = 28 days) throughout their treatment with the study drugs, and at least once during RT.
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Patients With Prostate Cancer
Eligible patients will receive a total of 6 months of leuprolide, abiraterone, and ARN-509 to begin three months prior to RT and continuing until approximately 3 months post-RT. Patients will be assessed every 4 weeks (±1 week) (a cycle = 28 days) throughout their treatment with the study drugs, and at least once during RT.
|
|---|---|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Progressive disease
|
2
|
Baseline Characteristics
AASUR in High Risk Prostate Cancer
Baseline characteristics by cohort
| Measure |
Patients With Prostate Cancer
n=64 Participants
Eligible patients will receive a total of 6 months of leuprolide, abiraterone, and ARN-509 to begin three months prior to RT and continuing until approximately 3 months post-RT. Patients will be assessed every 4 weeks (±1 week) (a cycle = 28 days) throughout their treatment with the study drugs, and at least once during RT.
|
|---|---|
|
Age, Continuous
|
69 years
n=193 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=193 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=193 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=193 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=193 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=193 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=193 Participants
|
|
Region of Enrollment
United States
|
64 Participants
n=193 Participants
|
PRIMARY outcome
Timeframe: 36 monthsBiochemical failure is defined as an increase in PSA by more than 2ng/mL above the nadir value. PSA rise equals or exceeds 2ng/mL will be the date of failure.
Outcome measures
| Measure |
Patients With Prostate Cancer
n=64 Participants
Eligible patients will receive a total of 6 months of leuprolide, abiraterone, and ARN-509 to begin three months prior to RT and continuing until approximately 3 months post-RT. Patients will be assessed every 4 weeks (±1 week) (a cycle = 28 days) throughout their treatment with the study drugs, and at least once during RT.
|
|---|---|
|
Number of Participants With Biochemical Failure
Participants with increase in PSA by more than 2ng/mL above the nadir value
|
12 Participants
|
|
Number of Participants With Biochemical Failure
Participants without increase in PSA by more than 2ng/mL above the nadir value
|
52 Participants
|
Adverse Events
Patients With Prostate Cancer
Serious events: 6 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients With Prostate Cancer
n=64 participants at risk
Eligible patients will receive a total of 6 months of leuprolide, abiraterone, and ARN-509 to begin three months prior to RT and continuing until approximately 3 months post-RT. Patients will be assessed every 4 weeks (±1 week) (a cycle = 28 days) throughout their treatment with the study drugs, and at least once during RT.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/64 • 36 months
|
|
Investigations
Neutrophil count decreased
|
1.6%
1/64 • 36 months
|
|
Nervous system disorders
Presyncope
|
1.6%
1/64 • 36 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.6%
1/64 • 36 months
|
|
Vascular disorders
Hypertension
|
1.6%
1/64 • 36 months
|
|
Vascular disorders
Hypotension
|
1.6%
1/64 • 36 months
|
Other adverse events
| Measure |
Patients With Prostate Cancer
n=64 participants at risk
Eligible patients will receive a total of 6 months of leuprolide, abiraterone, and ARN-509 to begin three months prior to RT and continuing until approximately 3 months post-RT. Patients will be assessed every 4 weeks (±1 week) (a cycle = 28 days) throughout their treatment with the study drugs, and at least once during RT.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
10.9%
7/64 • 36 months
|
|
Cardiac disorders
Angina pectoris
|
1.6%
1/64 • 36 months
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
2/64 • 36 months
|
|
Cardiac disorders
Myocardial infarction
|
1.6%
1/64 • 36 months
|
|
Cardiac disorders
Palpitations
|
3.1%
2/64 • 36 months
|
|
Ear and labyrinth disorders
Tinnitus
|
1.6%
1/64 • 36 months
|
|
Ear and labyrinth disorders
Vertigo
|
1.6%
1/64 • 36 months
|
|
Endocrine disorders
Hypothyroidism
|
3.1%
2/64 • 36 months
|
|
Eye disorders
Asthenopia
|
1.6%
1/64 • 36 months
|
|
Eye disorders
Blindness
|
1.6%
1/64 • 36 months
|
|
Eye disorders
Conjunctival haemorrhage
|
1.6%
1/64 • 36 months
|
|
Eye disorders
Dry eye
|
1.6%
1/64 • 36 months
|
|
Eye disorders
Glaucoma
|
1.6%
1/64 • 36 months
|
|
Eye disorders
Photophobia
|
1.6%
1/64 • 36 months
|
|
Eye disorders
Vision blurred
|
4.7%
3/64 • 36 months
|
|
Eye disorders
Visual impairment
|
1.6%
1/64 • 36 months
|
|
Gastrointestinal disorders
Abdominal distension
|
3.1%
2/64 • 36 months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
1/64 • 36 months
|
|
Gastrointestinal disorders
Anal haemorrhage
|
1.6%
1/64 • 36 months
|
|
Gastrointestinal disorders
Anal incontinence
|
1.6%
1/64 • 36 months
|
|
Gastrointestinal disorders
Constipation
|
23.4%
15/64 • 36 months
|
|
Gastrointestinal disorders
Diarrhoea
|
23.4%
15/64 • 36 months
|
|
Gastrointestinal disorders
Dry mouth
|
4.7%
3/64 • 36 months
|
|
Gastrointestinal disorders
Dyspepsia
|
1.6%
1/64 • 36 months
|
|
Gastrointestinal disorders
Flatulence
|
6.2%
4/64 • 36 months
|
|
Gastrointestinal disorders
Frequent bowel movements
|
4.7%
3/64 • 36 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.6%
1/64 • 36 months
|
|
Gastrointestinal disorders
Haematochezia
|
6.2%
4/64 • 36 months
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.6%
1/64 • 36 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
7.8%
5/64 • 36 months
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
1.6%
1/64 • 36 months
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.6%
1/64 • 36 months
|
|
Gastrointestinal disorders
Nausea
|
6.2%
4/64 • 36 months
|
|
Gastrointestinal disorders
Proctalgia
|
3.1%
2/64 • 36 months
|
|
Gastrointestinal disorders
Proctitis
|
1.6%
1/64 • 36 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
4.7%
3/64 • 36 months
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
2/64 • 36 months
|
|
General disorders
Fatigue
|
57.8%
37/64 • 36 months
|
|
General disorders
Gait disturbance
|
1.6%
1/64 • 36 months
|
|
General disorders
Localised oedema
|
1.6%
1/64 • 36 months
|
|
General disorders
Oedema peripheral
|
17.2%
11/64 • 36 months
|
|
General disorders
Pain
|
1.6%
1/64 • 36 months
|
|
General disorders
Pyrexia
|
4.7%
3/64 • 36 months
|
|
Infections and infestations
Upper respiratory tract infection
|
4.7%
3/64 • 36 months
|
|
Injury, poisoning and procedural complications
Animal bite
|
1.6%
1/64 • 36 months
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.6%
1/64 • 36 months
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
1.6%
1/64 • 36 months
|
|
General disorders
Muscle strain
|
1.6%
1/64 • 36 months
|
|
Investigations
Alanine aminotransferase increased
|
14.1%
9/64 • 36 months
|
|
Investigations
Aspartate aminotransferase increased
|
14.1%
9/64 • 36 months
|
|
Investigations
Blood alkaline phosphatase increased
|
3.1%
2/64 • 36 months
|
|
Investigations
Blood bilirubin increased
|
1.6%
1/64 • 36 months
|
|
Investigations
Blood creatinine decreased
|
1.6%
1/64 • 36 months
|
|
Investigations
Blood creatinine increased
|
4.7%
3/64 • 36 months
|
|
Investigations
Blood urea increased
|
9.4%
6/64 • 36 months
|
|
Investigations
Haematocrit decreased
|
7.8%
5/64 • 36 months
|
|
Investigations
Haemoglobin increased
|
1.6%
1/64 • 36 months
|
|
Investigations
Lymphocyte count decreased
|
15.6%
10/64 • 36 months
|
|
Investigations
Neutrophil count decreased
|
3.1%
2/64 • 36 months
|
|
Investigations
Platelet count decreased
|
6.2%
4/64 • 36 months
|
|
Investigations
Red blood cell count decreased
|
9.4%
6/64 • 36 months
|
|
Investigations
Red blood cell count increased
|
1.6%
1/64 • 36 months
|
|
Investigations
Tri-iodothyronine decreased
|
3.1%
2/64 • 36 months
|
|
Investigations
Weight decreased
|
7.8%
5/64 • 36 months
|
|
Investigations
Weight Increased
|
7.8%
5/64 • 36 months
|
|
Investigations
White blood cell count decreased
|
4.7%
3/64 • 36 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.7%
3/64 • 36 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.1%
2/64 • 36 months
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
3.1%
2/64 • 36 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
28.1%
18/64 • 36 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.2%
4/64 • 36 months
|
|
Metabolism and nutrition disorders
Hypocholesterolaemia
|
1.6%
1/64 • 36 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.2%
4/64 • 36 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
1/64 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
3/64 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.1%
2/64 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.6%
1/64 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.1%
2/64 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.7%
3/64 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.6%
1/64 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.6%
1/64 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
8/64 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.7%
3/64 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.1%
2/64 • 36 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
1.6%
1/64 • 36 months
|
|
Nervous system disorders
Cognitive disorder
|
6.2%
4/64 • 36 months
|
|
Nervous system disorders
Dizziness
|
20.3%
13/64 • 36 months
|
|
Nervous system disorders
Dysgeusia
|
4.7%
3/64 • 36 months
|
|
Nervous system disorders
Headache
|
12.5%
8/64 • 36 months
|
|
Nervous system disorders
Memory impairment
|
6.2%
4/64 • 36 months
|
|
Nervous system disorders
Neuralgia
|
1.6%
1/64 • 36 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.7%
3/64 • 36 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.7%
3/64 • 36 months
|
|
Nervous system disorders
Presyncope
|
1.6%
1/64 • 36 months
|
|
Nervous system disorders
Syncope
|
1.6%
1/64 • 36 months
|
|
Psychiatric disorders
Agitation
|
1.6%
1/64 • 36 months
|
|
Psychiatric disorders
Anxiety
|
4.7%
3/64 • 36 months
|
|
Psychiatric disorders
Confusional state
|
3.1%
2/64 • 36 months
|
|
Psychiatric disorders
Depression
|
7.8%
5/64 • 36 months
|
|
Psychiatric disorders
Insomnia
|
20.3%
13/64 • 36 months
|
|
Psychiatric disorders
Irritability
|
3.1%
2/64 • 36 months
|
|
Psychiatric disorders
Libido decreased
|
32.8%
21/64 • 36 months
|
|
Psychiatric disorders
Mood altered
|
1.6%
1/64 • 36 months
|
|
Psychiatric disorders
Restlessness
|
1.6%
1/64 • 36 months
|
|
Psychiatric disorders
Suicidal ideation
|
1.6%
1/64 • 36 months
|
|
Renal and urinary disorders
Chromaturia
|
1.6%
1/64 • 36 months
|
|
Renal and urinary disorders
Dysuria
|
7.8%
5/64 • 36 months
|
|
Renal and urinary disorders
Haematuria
|
9.4%
6/64 • 36 months
|
|
Renal and urinary disorders
Micturition urgency
|
28.1%
18/64 • 36 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.6%
1/64 • 36 months
|
|
Renal and urinary disorders
Nocturia
|
14.1%
9/64 • 36 months
|
|
Renal and urinary disorders
Pollakiuria
|
50.0%
32/64 • 36 months
|
|
Renal and urinary disorders
Proteinuria
|
1.6%
1/64 • 36 months
|
|
Renal and urinary disorders
Urinary hesitation
|
1.6%
1/64 • 36 months
|
|
Renal and urinary disorders
Urinary incontinence
|
3.1%
2/64 • 36 months
|
|
Renal and urinary disorders
Urinary retention
|
14.1%
9/64 • 36 months
|
|
Renal and urinary disorders
Urinary tract pain
|
12.5%
8/64 • 36 months
|
|
Renal and urinary disorders
Urine flow
|
7.8%
5/64 • 36 months
|
|
Reproductive system and breast disorders
Breast mass
|
1.6%
1/64 • 36 months
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
3.1%
2/64 • 36 months
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
10.9%
7/64 • 36 months
|
|
Reproductive system and breast disorders
Haematospermia
|
1.6%
1/64 • 36 months
|
|
Reproductive system and breast disorders
Nipple pain
|
1.6%
1/64 • 36 months
|
|
Reproductive system and breast disorders
Penile blister
|
1.6%
1/64 • 36 months
|
|
Reproductive system and breast disorders
Prostatic pain
|
1.6%
1/64 • 36 months
|
|
Reproductive system and breast disorders
Prostatomegaly
|
1.6%
1/64 • 36 months
|
|
Reproductive system and breast disorders
Scrotal pain
|
1.6%
1/64 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
1.6%
1/64 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.1%
9/64 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.6%
1/64 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.6%
10/64 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.1%
2/64 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
1.6%
1/64 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
1.6%
1/64 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.1%
2/64 • 36 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
7.8%
5/64 • 36 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
4/64 • 36 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
3.1%
2/64 • 36 months
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
1.6%
1/64 • 36 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.8%
5/64 • 36 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.1%
9/64 • 36 months
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.6%
1/64 • 36 months
|
|
Skin and subcutaneous tissue disorders
Skin texture abnormal
|
1.6%
1/64 • 36 months
|
|
Vascular disorders
Flushing
|
1.6%
1/64 • 36 months
|
|
Vascular disorders
Haematoma
|
1.6%
1/64 • 36 months
|
|
Vascular disorders
Hot flush
|
79.7%
51/64 • 36 months
|
|
Vascular disorders
Hypertension
|
50.0%
32/64 • 36 months
|
|
Vascular disorders
Hypotension
|
1.6%
1/64 • 36 months
|
Additional Information
Dr. Sean McBride, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-608-2450
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place