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Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00002597
First received: November 1, 1999
Last updated: May 8, 2017
Last verified: May 2017
Results First Received: May 8, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: flutamide
Drug: Zoladex
Drug: Lupron
Radiation: radiation therapy

  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
No text entered.

Reporting Groups
  Description
Hormone Therapy + Radiation Therapy Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
Radiation Therapy Alone Radiation therapy alone

Participant Flow:   Overall Study
    Hormone Therapy + Radiation Therapy   Radiation Therapy Alone
STARTED   1013   1015 
COMPLETED   987 [1]   992 [1] 
NOT COMPLETED   26   23 
Protocol Violation                19                17 
Withdrawal by Subject                7                6 
[1] Subjects with data available for the primary analysis are considered to have completed the study.



  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.
All eligible patients.

Reporting Groups
  Description
Hormone Therapy + Radiation Therapy Neoadjuvant total androgen suppression (TAS) - Flutamide and Zoladex or Lupron - two months before and during radiation therapy.
Radiation Therapy Alone Radiation therapy alone
Total Total of all reporting groups

Baseline Measures
   Hormone Therapy + Radiation Therapy   Radiation Therapy Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 987   992   1979 
Age 
[Units: Years]
Median (Full Range)
 70 
 (47 to 91) 
 71 
 (47 to 88) 
 71 
 (47 to 91) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      987 100.0%      992 100.0%      1979 100.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival Rate (10-year)   [ Time Frame: From date of randomization to 10 years ]

2.  Secondary:   Disease-specific Survival Rate (10 Years)   [ Time Frame: From registration to 10 years ]

3.  Secondary:   Local Progression Rate (10 Years)   [ Time Frame: From registration to 10 years ]

4.  Secondary:   Distant Failure Rate (10 Years)   [ Time Frame: From registration to 10 years ]

5.  Secondary:   Biochemical Failure Rate (10 Years)   [ Time Frame: From registration to 10 years ]

6.  Secondary:   Clinical Relapse Rate (10 Years)   [ Time Frame: From registration to 10 years ]

7.  Secondary:   Second Biochemical Relapse Rate (10 Years)   [ Time Frame: From registration to 10 years ]

8.  Secondary:   Disease-free Survival Rate (10 Years)   [ Time Frame: From registration to 10 years ]

9.  Secondary:   Positive Re-biopsy Rate at Two Years   [ Time Frame: From registration to two years ]


  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
No text entered.


  More Information
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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:
McGowan D, Hunt D, Jones C, et al.: Effect of short-term endocrine therapy prior to and during radiation therapy on overall survival in patients with T1b-T2b adenocarcinoma of the prostate and PSA equal to or less than 20: initial results of RTOG 94-08. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-6, 2010.

Other Publications:
Bruner D, Scott C, McGowan D, et al.: Factors influencing sexual outcomes in prostate cancer patients enrolled on radiation therapy oncology group studies 90-20 and 94-08. [Abstract] Proceedings of the International Society for Quality of Life Research 7: 575, 1998.
Bruner DW, Scott CB, McGowan D, et al.: Validation of the sexual adjustment questionnaire (SAQ) in prostate cancer patients enrolled on Radiation Therapy Oncology Group studies 90-20 and 94-08. [Abstract] Int J Radiat Oncol Biol Phys 42 (suppl 1): A-156, 202, 1998.


Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00002597     History of Changes
Other Study ID Numbers: RTOG-9408
CDR0000063821
Study First Received: November 1, 1999
Results First Received: May 8, 2017
Last Updated: May 8, 2017