Cabazitaxel and Radiation For Patients With Pathologically Determined Stage 3 Prostate Cancer and/or Patients With PSA Elevation (>0.1- < 2.0 ng/mL)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Dr Anthony Mega, Brown University
ClinicalTrials.gov Identifier:
NCT01650285
First received: July 24, 2012
Last updated: June 9, 2015
Last verified: June 2015
Results First Received: July 14, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: Cabazitaxel

  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
Cabazitaxel and Radiation

Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.

Cabazitaxel: Dose Level Day 1, 22, 43

  1. 5.0 mg/m2
  2. 10.0 mg/m2
  3. 15.0 mg/m2
  4. 20.0 mg/m2

Participant Flow:   Overall Study
    Cabazitaxel and Radiation  
STARTED     5  
COMPLETED     4  
NOT COMPLETED     1  
Adverse Event                 1  



  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.
No text entered.

Reporting Groups
  Description
Cabazitaxel and Radiation

Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.

Cabazitaxel: Dose Level Day 1, 22, 43

  1. 5.0 mg/m2
  2. 10.0 mg/m2
  3. 15.0 mg/m2
  4. 20.0 mg/m2

Baseline Measures
    Cabazitaxel and Radiation  
Number of Participants  
[units: participants]
  5  
Age  
[units: years]
Mean (Full Range)
  61  
  (56 to 64)  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     5  
>=65 years     0  
Gender  
[units: participants]
 
Female     0  
Male     5  
Region of Enrollment  
[units: participants]
 
United States     5  



  Outcome Measures

1.  Primary:   Maximum Tolerated Dose of Cabazitaxel With Concurrent Adjuvant Radiation   [ Time Frame: 2 mos ]

2.  Secondary:   Toxicity Associated With Cabazitaxel and Adjuvant Radiation   [ Time Frame: 2 mos ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Other Pre-specified:   Time to Progression and Overall Survival for Patients-Following Radical Prostatectomy and Were Treated With Cabazitaxel.   [ Time Frame: 24 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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: Dr. Anthony Mega
Organization: BrUOG
phone: 4018633000
e-mail: kayla_rosati@brown.edu



Responsible Party: Dr Anthony Mega, Brown University
ClinicalTrials.gov Identifier: NCT01650285     History of Changes
Other Study ID Numbers: BrUOG 246
Study First Received: July 24, 2012
Results First Received: July 14, 2014
Last Updated: June 9, 2015
Health Authority: United States: Food and Drug Administration