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Trial record 22 of 1272 for:    prostate cancer AND radiation

Samarium Sm 153 Lexidronam Pentasodium and 3-Dimensional Conformal Radiation Therapy or Intensity-Modulated Radiation Therapy in Treating Patients With Rising Prostate-Specific Antigen Levels After Radical Prostatectomy for 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: NCT00551525
Recruitment Status : Completed
First Posted : October 31, 2007
Results First Posted : July 25, 2017
Last Update Posted : July 25, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Radiation: Radiotherapy
Drug: Samarium 153

  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
Radiotherapy + Samarium 153 Samarium 153 infusion followed by radiotherapy 12 weeks later

Participant Flow:   Overall Study
    Radiotherapy + Samarium 153
STARTED   67 
COMPLETED   62 [1] 
NOT COMPLETED   5 
Protocol Violation                5 
[1] Subjects with data available for 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.
All eligible patients

Reporting Groups
  Description
Radiotherapy + Samarium 153 Samarium 153 infusion followed by radiotherapy 12 weeks later

Baseline Measures
   Radiotherapy + Samarium 153 
Overall Participants Analyzed 
[Units: Participants]
 62 
Age 
[Units: Years]
Median (Full Range)
 65 
 (49 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      62 100.0% 


  Outcome Measures

1.  Primary:   Proportion of Patients With PSA Response (pt) Within 12 Weeks of Samarium 153 Administration   [ Time Frame: Twelve weeks from the date of Samarium 153 infusion. ]

2.  Secondary:   Completion of Therapy   [ Time Frame: 90 days from the end of radiation therapy. ]

3.  Secondary:   Number of Patients With Hematologic Toxicity at 12 Weeks   [ Time Frame: Twelve weeks from the date of Samarium 153 infusion. ]

4.  Secondary:   Samarium 153-related Adverse Events at 12 Weeks (Percentage of Patients)   [ Time Frame: Twelve weeks from the date of Samarium 153 infusion ]

5.  Secondary:   Acute and Late Radiotherapy-Related Adverse Events   [ Time Frame: 90 days from start of radiotherapy ]

6.  Secondary:   Freedom From Progression (FFP) Rate at 2 Years   [ Time Frame: From randomization to 2 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
Comparison of freedom from progression rate at two years with Kattan Nomograms was not possible because the pretreatment data needed for the Kattan Nomograms was not collected.


  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: NCT00551525     History of Changes
Obsolete Identifiers: NCT01317043
Other Study ID Numbers: RTOG-0622
CDR0000570622
NCI-2009-01094 ( Registry Identifier: CTRP(Clinical Trial Reporting Program) )
First Submitted: October 30, 2007
First Posted: October 31, 2007
Results First Submitted: September 6, 2016
Results First Posted: July 25, 2017
Last Update Posted: July 25, 2017