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Abiraterone Prednisone and Hormonal Therapy Before and During Radiation Therapy in Localized Prostate Cancer (RAD1)

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ClinicalTrials.gov Identifier: NCT01023061
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bruce Montgomery, University of Washington

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Prostate
Stage II Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Interventions Drug: abiraterone acetate
Drug: prednisone
Drug: leuprolide acetate
Other: laboratory biomarker analysis
Radiation: external beam radiation therapy
Drug: goserelin acetate
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Antihormone Therapy and Radiation Therapy)
Hide Arm/Group Description

Patients receive abiraterone acetate and prednisone daily for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

abiraterone acetate: Given orally

prednisone: Given orally

leuprolide acetate: Given via injection

laboratory biomarker analysis: Correlative study

external beam radiation therapy: Undergo radiotherapy

goserelin acetate: Given via injection

Period Title: Overall Study
Started 24
Completed [1] 22
Not Completed 2
Reason Not Completed
Withdrawal prior to treatment             2
[1]
2 patients enrolled but withdrew from study prior to receiving study therapy
Arm/Group Title Treatment (Antihormone Therapy and Radiation Therapy)
Hide Arm/Group Description

Patients receive abiraterone acetate and prednisone for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

abiraterone acetate: Given orally

prednisone: Given orally

leuprolide acetate: Given via injection

laboratory biomarker analysis: Correlative study

external beam radiation therapy: Undergo radiotherapy

goserelin acetate: Given via injection

Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
Men with intermediate or high risk localized prostate cancer
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants
61  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Female
0
   0.0%
Male
24
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants
24
1.Primary Outcome
Title Incidence of Acute and Chronic Grade 3 or Greater Toxicity as Evaluated Using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 3.0
Hide Description Incidence of acute and chronic grade 3 or greater toxicity as evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0he distribution of time to late adverse events (observed severities of adverse events over time) will be estimated using the Kaplan-Meier method.
Time Frame Up to 24 months after initiation of radiation therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated patients
Arm/Group Title Treatment (Antihormone Therapy and Radiation Therapy)
Hide Arm/Group Description:

Patients receive abiraterone acetate PO and prednisone PO for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

abiraterone acetate: Given PO

prednisone: Given PO

leuprolide acetate: Given via injection

laboratory biomarker analysis: Correlative study

external beam radiation therapy: Undergo radiotherapy

goserelin acetate: Given via injection

Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
6
  27.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Treatment (Antihormone Therapy and Radiation Therapy)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.74
Estimation Comments [Not Specified]
2.Primary Outcome
Title Levels of Dihydrotestosterone (DHT) and Testosterone in Prostate Biopsy Sample Assessed by Mass Spectrometry
Hide Description The levels from patients treated in this study will be compared to a control set of biopsies acquired from a separate but similar population of men with intermediate and high risk prostate cancer treated with three months of combined Luteinizing hormone releasing hormone agonist and bicalutamide as part of standard of care.
Time Frame Week 12
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Hide Analysis Population Description
Treated patients with measurable tissue DHT
Arm/Group Title Treatment (Antihormone Therapy and Radiation Therapy)
Hide Arm/Group Description:

Patients receive abiraterone acetate PO and prednisone PO for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

abiraterone acetate: Given PO

prednisone: Given PO

leuprolide acetate: Given via injection

laboratory biomarker analysis: Correlative study

external beam radiation therapy: Undergo radiotherapy

goserelin acetate: Given via injection

Overall Number of Participants Analyzed 22
Median (90% Confidence Interval)
Unit of Measure: pg/mg
0.050
(0.050 to 0.050)
3.Secondary Outcome
Title Median Time to Prostate Specific Antigen Progression
Hide Description Defined as the date of an increase of 2ng/mL or more above the Prostate specific antigen nadir achieved after completion of radiation with the date of progression defined as the date on which that value was measured. Distribution of time-to-event variables will be estimated using the Kaplan-Meier product-limit method. Estimated with two-sided 95% confidence intervals.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Treated patients
Arm/Group Title Treatment (Antihormone Therapy and Radiation Therapy)
Hide Arm/Group Description:

Patients receive abiraterone acetate PO and prednisone PO for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

abiraterone acetate: Given PO

prednisone: Given PO

leuprolide acetate: Given via injection

laboratory biomarker analysis: Correlative study

external beam radiation therapy: Undergo radiotherapy

goserelin acetate: Given via injection

Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: years
5  (1)
Time Frame Median follow-up 21 months
Adverse Event Reporting Description Tracked grade 1 and 2 toxicities >10% and grade 3 toxicities that were either possibly or probably related to radiation, abiraterone or prednisone, or Luteinizing hormone releasing hormone agonist.
 
Arm/Group Title Treatment (Antihormone Therapy and Radiation Therapy)
Hide Arm/Group Description

Patients receive abiraterone acetate and prednisone for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

abiraterone acetate: Given orally

prednisone: Given orally

leuprolide acetate: Given via injection

laboratory biomarker analysis: Correlative study

external beam radiation therapy: Undergo radiotherapy

goserelin acetate: Given via injection

All-Cause Mortality
Treatment (Antihormone Therapy and Radiation Therapy)
Affected / at Risk (%)
Total   0/24 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Antihormone Therapy and Radiation Therapy)
Affected / at Risk (%) # Events
Total   0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Antihormone Therapy and Radiation Therapy)
Affected / at Risk (%) # Events
Total   19/22 (86.36%)    
Blood and lymphatic system disorders   
Lymphopenia * 1  19/22 (86.36%)  19
Cardiac disorders   
Hypertension * 1  8/22 (36.36%)  8
Gastrointestinal disorders   
Diarrhea * 1  9/22 (40.91%)  9
General disorders   
fatigue * 1  15/22 (68.18%)  15
insomnia * 1  3/22 (13.64%)  3
Hepatobiliary disorders   
Hyperbilirubinemia * 1  5/22 (22.73%)  5
Investigations   
hypokalemia syndrome * 1  12/22 (54.55%)  12
Metabolism and nutrition disorders   
ALT and AST: increased * 1  7/22 (31.82%)  7
Renal and urinary disorders   
urinary tract discomfort * 1  19/22 (86.36%)  19
Reproductive system and breast disorders   
erectile dysfunction * 1  7/22 (31.82%)  7
Vascular disorders   
Hot flashes * 1  15/22 (68.18%)  15
1
Term from vocabulary, MedDRA (10.0)
*
Indicates events were collected by non-systematic assessment
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
Name/Title: Bruce Montgomery
Organization: University of Washington
Phone: 206-598-0860
Responsible Party: Bruce Montgomery, University of Washington
ClinicalTrials.gov Identifier: NCT01023061     History of Changes
Other Study ID Numbers: 7048
NCI-2009-01346 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
7048 - AbiRAD
7048 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: November 30, 2009
First Posted: December 2, 2009
Results First Submitted: March 23, 2017
Results First Posted: June 6, 2017
Last Update Posted: June 6, 2017