Trial Outcomes & Findings for Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer (NCT NCT01088529)
NCT ID: NCT01088529
Last Updated: 2014-05-15
Results Overview
The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
At the end of Cycle 3 (at radical prostatectomy)
Results posted on
2014-05-15
Participant Flow
The study was conducted from 20 November 2009 to 14 March 2013. Participants were recruited at 1 study center in the United States.
66 participants were randomly allocated to the 2 treatment arms and were included in the intent-to-treat (ITT) analysis set. 65 participants received at least 1 dose of the study drug and were included in the safety analysis set.
Participant milestones
| Measure |
AA+LHRHa
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
|
LHRHa
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
22
|
|
Overall Study
Received Treatment
|
44
|
21
|
|
Overall Study
COMPLETED
|
44
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
AA+LHRHa
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
|
LHRHa
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
|
|---|---|---|
|
Overall Study
Did not receive study treatment
|
0
|
1
|
Baseline Characteristics
Neo-adjuvant Abiraterone + Luteinizing Hormone-Releasing Hormone (LHRH) Versus LHRH in Prostate Cancer
Baseline characteristics by cohort
| Measure |
AA+LHRHa
n=44 Participants
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
|
LHRHa
n=22 Participants
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 7.14 • n=5 Participants
|
59.9 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
61 years
STANDARD_DEVIATION 7.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the end of Cycle 3 (at radical prostatectomy)Population: Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study.
The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2.
Outcome measures
| Measure |
AA+LHRHa
n=44 Participants
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
|
LHRHa
n=22 Participants
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
|
|---|---|---|
|
Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2)
|
24 participants
|
8 participants
|
SECONDARY outcome
Timeframe: At the end of Cycle 3 (at radical prostatectomy)Population: Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study.
The table below shows number of participants in each treatment group who had positive surgical margins. A positive surgical margin is defined as tumor extending to the inked-surface or margin of the prostate.
Outcome measures
| Measure |
AA+LHRHa
n=44 Participants
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
|
LHRHa
n=22 Participants
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
|
|---|---|---|
|
Number of Participants With a Positive Surgical Margin at Radical Prostatectomy
|
6 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Cycle 3 Day 1Population: Intent-to-treat (ITT) analysis set, which included all participants who were randomized to study. Here, "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure.
The table below shows number of participants in each treatment group who achieved a prostate-specific antigen (PSA) response defined as a drop in PSA value to less than or equal to 0.2 ng/mL.
Outcome measures
| Measure |
AA+LHRHa
n=44 Participants
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
|
LHRHa
n=20 Participants
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
|
|---|---|---|
|
Number of Participants With Prostate-Specific Antigen Response
|
32 participants
|
0 participants
|
Adverse Events
AA+LHRHa
Serious events: 2 serious events
Other events: 43 other events
Deaths: 0 deaths
LHRHa
Serious events: 2 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AA+LHRHa
n=44 participants at risk
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
|
LHRHa
n=21 participants at risk
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
|
|---|---|---|
|
Gastrointestinal disorders
Gastric Ileus
|
0.00%
0/44 • 3 years
|
4.8%
1/21 • 3 years
|
|
Infections and infestations
Infected Lymphocele
|
2.3%
1/44 • 3 years
|
0.00%
0/21 • 3 years
|
|
Infections and infestations
Pelvic Abscess
|
0.00%
0/44 • 3 years
|
4.8%
1/21 • 3 years
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
2.3%
1/44 • 3 years
|
0.00%
0/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
2.3%
1/44 • 3 years
|
0.00%
0/21 • 3 years
|
Other adverse events
| Measure |
AA+LHRHa
n=44 participants at risk
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
|
LHRHa
n=21 participants at risk
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
52.3%
23/44 • 3 years
|
38.1%
8/21 • 3 years
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.5%
2/44 • 3 years
|
9.5%
2/21 • 3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
6.8%
3/44 • 3 years
|
9.5%
2/21 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
9.1%
4/44 • 3 years
|
9.5%
2/21 • 3 years
|
|
General disorders
Fatigue
|
43.2%
19/44 • 3 years
|
47.6%
10/21 • 3 years
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
18.2%
8/44 • 3 years
|
4.8%
1/21 • 3 years
|
|
Investigations
Alanine Aminotransferase Increased
|
50.0%
22/44 • 3 years
|
33.3%
7/21 • 3 years
|
|
Investigations
Aspartate Aminotransferase Increased
|
38.6%
17/44 • 3 years
|
33.3%
7/21 • 3 years
|
|
Investigations
Blood Sodium Increased
|
2.3%
1/44 • 3 years
|
9.5%
2/21 • 3 years
|
|
Investigations
Blood Urea Increased
|
0.00%
0/44 • 3 years
|
9.5%
2/21 • 3 years
|
|
Investigations
Blood Uric Acid Increased
|
6.8%
3/44 • 3 years
|
4.8%
1/21 • 3 years
|
|
Investigations
Platelet Count Decreased
|
9.1%
4/44 • 3 years
|
0.00%
0/21 • 3 years
|
|
Investigations
White Blood Cell Count Decreased
|
6.8%
3/44 • 3 years
|
0.00%
0/21 • 3 years
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
20.5%
9/44 • 3 years
|
23.8%
5/21 • 3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
20.5%
9/44 • 3 years
|
14.3%
3/21 • 3 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.3%
1/44 • 3 years
|
9.5%
2/21 • 3 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
13.6%
6/44 • 3 years
|
9.5%
2/21 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.4%
5/44 • 3 years
|
0.00%
0/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
3/44 • 3 years
|
4.8%
1/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.5%
2/44 • 3 years
|
9.5%
2/21 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
4/44 • 3 years
|
0.00%
0/21 • 3 years
|
|
Nervous system disorders
Cognitive Disorder
|
6.8%
3/44 • 3 years
|
0.00%
0/21 • 3 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/44 • 3 years
|
9.5%
2/21 • 3 years
|
|
Psychiatric disorders
Insomnia
|
6.8%
3/44 • 3 years
|
28.6%
6/21 • 3 years
|
|
Renal and urinary disorders
Pollakiuria
|
6.8%
3/44 • 3 years
|
0.00%
0/21 • 3 years
|
|
Renal and urinary disorders
Urinary Incontinence
|
6.8%
3/44 • 3 years
|
14.3%
3/21 • 3 years
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
2.3%
1/44 • 3 years
|
9.5%
2/21 • 3 years
|
|
Vascular disorders
Hot Flush
|
84.1%
37/44 • 3 years
|
85.7%
18/21 • 3 years
|
|
Vascular disorders
Hypertension
|
22.7%
10/44 • 3 years
|
14.3%
3/21 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60