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Radiation Therapy in Treating Patients With Prostate Cancer

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: NCT01434290
Recruitment Status : Active, not recruiting
First Posted : September 14, 2011
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Prostate Cancer
Psychosocial Effects of Cancer and Its Treatment
Radiation Toxicity
Sexual Dysfunction
Interventions: Radiation: 36.25 Gy IMRT
Radiation: 51.6 Gy IMRT

  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
5 Fractions 36.25 Gy IMRT (intensity modulated radiation therapy) in 5 fractions over two and a half weeks
12 Fractions 51.6 Gy IMRT in 12 fractions over two and a half weeks

Participant Flow:   Overall Study
    5 Fractions   12 Fractions
STARTED   127   128 
COMPLETED   119 [1]   121 [1] 
NOT COMPLETED   8   7 
Protocol Violation                6                3 
No protocol treatment                2                4 
[1] Eligible subjects included in analysis



  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 started protocol treatment

Reporting Groups
  Description
5 Fractions 36.25 Gy IMRT in 5 fractions over two and a half weeks
12 Fractions 51.6 Gy IMRT in 12 fractions over two and a half weeks
Total Total of all reporting groups

Baseline Measures
   5 Fractions   12 Fractions   Total 
Overall Participants Analyzed 
[Units: Participants]
 119   121   240 
Age 
[Units: Years]
Median (Full Range)
 64 
 (48 to 77) 
 66 
 (50 to 79) 
 65 
 (48 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      119 100.0%      121 100.0%      240 100.0% 


  Outcome Measures

1.  Primary:   Percentage of Patients With Reduction From Baseline to the One-year EPIC Bowel Domain Score That Exceeds 5 Points   [ Time Frame: Baseline and one year from the end of protocol treatment ]

2.  Primary:   The Percentage of Patients With Reduction From Baseline to One-year EPIC Urinary Domain Score That Exceeds 2 Points   [ Time Frame: Baseline and one year from the end of protocol treatment ]

3.  Secondary:   Acute and Late Gastrointestinal (GI) and Genitourinary (GU) Toxicity for Each Arm   [ Time Frame: Start of protocol treatment to one year from the end of protocol treatment ]

4.  Secondary:   Rate of PSA Failure   [ Time Frame: Registration to one year from the end of protocol treatment ]

5.  Secondary:   Rate of Disease-free Survival (DFS)   [ Time Frame: Registration to 1 year from the end of protocol treatment ]

6.  Secondary:   Change From Baseline in EPIC Bowel and Urinary HRQOL as Continuous Variables at One Year   [ Time Frame: Baseline and one year from the end of protocol treatment ]

7.  Secondary:   The Percentage of Patients With Reduction From Baseline at One Year in EPIC Sexual Domain Score That Exceeds 11 Points   [ Time Frame: Baseline one year from the end of protocol treatment ]

8.  Secondary:   The Percentage of Patients With Reduction From Baseline at One Year in EPIC Hormonal Domain Score That Exceeds 3 Points   [ Time Frame: Baseline and one year from the end of protocol treatment ]

9.  Secondary:   Change From Baseline in EQ-5D Scores   [ Time Frame: Baseline and one year from the end of protocol treatment ]

10.  Secondary:   Utilization of Sexual Medications/Devices Questionnaire Response Frequences   [ Time Frame: Baseline and one year from the end of protocol treatment ]

11.  Secondary:   Genetic Markers Associated With Normal Tissue Toxicities Resulting From Radiotherapy   [ Time Frame: Study entry to 5 years from the end of protocol treatment ]

12.  Secondary:   Quality Adjusted Life Years at 5 Years Using the EQ-5D and DFS   [ Time Frame: Registration to 5 years from the end of protocol treatment ]
Results not yet reported.   Anticipated Reporting Date:   06/2021  


  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



Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT01434290     History of Changes
Other Study ID Numbers: RTOG 0938
CDR0000703580
NCI-2011-03629 ( Registry Identifier: CTRP (Clinical Trials Reporting Program) )
First Submitted: September 13, 2011
First Posted: September 14, 2011
Results First Submitted: August 24, 2017
Results First Posted: November 17, 2017
Last Update Posted: November 17, 2017