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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bruce Montgomery, University of Washington
ClinicalTrials.gov Identifier:
NCT01023061
First received: November 30, 2009
Last updated: May 3, 2017
Last verified: May 2017
Results First Received: March 23, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment (Antihormone Therapy and Radiation Therapy)

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


Participant Flow:   Overall Study
    Treatment (Antihormone Therapy and Radiation Therapy)
STARTED   24 
COMPLETED [1]   22 
NOT COMPLETED   2 
Withdrawal prior to treatment                2 
[1] 2 patients enrolled but withdrew from study prior to receiving study therapy



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Men with intermediate or high risk localized prostate cancer

Reporting Groups
  Description
Treatment (Antihormone Therapy and Radiation Therapy)

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


Baseline Measures
   Treatment (Antihormone Therapy and Radiation Therapy) 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age 
[Units: Years]
Median (Standard Deviation)
 61  (9.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      24 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   24 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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   [ Time Frame: Up to 24 months after initiation of radiation therapy ]

2.  Primary:   Levels of Dihydrotestosterone (DHT) and Testosterone in Prostate Biopsy Sample Assessed by Mass Spectrometry   [ Time Frame: Week 12 ]

3.  Secondary:   Median Time to Prostate Specific Antigen Progression   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: rbmontgo@uw.edu


Publications:

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 )
Study First Received: November 30, 2009
Results First Received: March 23, 2017
Last Updated: May 3, 2017