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Trial record 40 of 1081 for:    prostate cancer AND radiation

Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002874
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Results First Posted : August 18, 2017
Last Update Posted : August 18, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: bicalutamide
Radiation: radiation therapy
Drug: placebo

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Bicalutamide Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Placebo Radiation therapy (64.8 Gy) + placebo (daily 2 years)

Participant Flow:   Overall Study
    Bicalutamide   Placebo
STARTED   421   419 
COMPLETED [1]   376   384 
NOT COMPLETED   45   35 
Withdrawal by Subject                1                1 
Protocol Violation                44                34 
[1] Subjects with data available for the primary analysis are considered to have completed the study.



  Baseline Characteristics

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.
Eligible patients who have not withdrawn

Reporting Groups
  Description
Bicalutamide Radiation therapy (64.8 Gy) + bicalutamide (150 mg daily 2 years)
Placebo Radiation therapy (64.8 Gy) + placebo (daily 2 years)
Total Total of all reporting groups

Baseline Measures
   Bicalutamide   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 376   384   760 
Age 
[Units: Years]
Median (Full Range)
 65 
 (45 to 81) 
 65 
 (40 to 83) 
 65 
 (40 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      376 100.0%      384 100.0%      760 100.0% 


  Outcome Measures

1.  Primary:   Overall Survival (12-year Rates Reported)   [ Time Frame: From date of randomization to 12 years. ]

2.  Secondary:   Non-Prostate Cancer Death (12-year Rates Reported)   [ Time Frame: From date of randomization to 12 years. ]

3.  Secondary:   Second PSA Recurrence (12-year Rates Reported)   [ Time Frame: From date of randomization to 12 years. ]

4.  Secondary:   Third PSA Recurrence (12-year Rates Reported)   [ Time Frame: From start of salvage hormone therapy to 12 years. ]

5.  Secondary:   PSA Complete Response at End of Protocol Treatment   [ Time Frame: End of protocol treatment, which is planned to last for two years ]

6.  Secondary:   Distant Failure (12-year Rates Reported)   [ Time Frame: From date of randomization to 12 years. ]

7.  Secondary:   Prostate Cancer Death (12-year Rates Reported)   [ Time Frame: From date of randomization to 12 years. ]

8.  Secondary:   Progression-free Survival (12-year Rates Reported)   [ Time Frame: From date of randomization to 12 years. ]

9.  Secondary:   Grade 3+ Toxicity   [ Time Frame: From date of randomization to four years. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org


Publications of Results:

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00002874     History of Changes
Other Study ID Numbers: RTOG-9601
CDR0000065158
RTOG-R9601
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: June 6, 2017
Results First Posted: August 18, 2017
Last Update Posted: August 18, 2017