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Multimodality Phase II Study in 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: NCT00734851
Recruitment Status : Terminated (Dose Limiting Toxicities)
First Posted : August 14, 2008
Results First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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

  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
36 participants consented. 2 participants withdrew consent prior to going on treatment. 34 participants started treatment. 2 participants withdrew while on treatment. 18 withdrawn by PI.

Reporting Groups
  Description
Multimodality 4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks

Participant Flow:   Overall Study
    Multimodality
STARTED   34 
COMPLETED   13 
NOT COMPLETED   21 
Withdrawal by Subject                2 
Lost to Follow-up                1 
Physician Decision                18 



  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.
No text entered.

Reporting Groups
  Description
Multimodality 4 cycles of 70 mg/m2 Docetaxel + 37.5 mg daily Sunitinib for 14 days followed by a 7 day break for 3 cycles + external beam radiotherapy to 66 Gray over 6-7 weeks

Baseline Measures
   Multimodality 
Overall Participants Analyzed 
[Units: Participants]
 34 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.76  (7.22) 
Gender 
[Units: Participants]
 
Female   0 
Male   34 


  Outcome Measures

1.  Primary:   The Rate of Progression Free Survival (PFS) at 24 Months   [ Time Frame: 2 years ]

2.  Secondary:   Proportion of Biochemical Progression (bPFS Proportion) at 2 and 3 Years.   [ Time Frame: 24 months and 36 months ]

3.  Secondary:   Rate of Local Recurrence at 2 and 3 Years   [ Time Frame: 24 months and 36 months ]

4.  Secondary:   Metastasis-free Survival (MFS) Rates at 2 and 3 Years.   [ Time Frame: 2 and 3 years ]

5.  Secondary:   Change in Quality of Life (QoL) After 1 Year   [ Time Frame: baseline and 1 year ]

6.  Secondary:   Change in Quality of Life (QoL) After 3 Month   [ Time Frame: baseline and 3 months ]

7.  Secondary:   Comparison of RNA Expression Profile From Original Prostate Radical Prostatectomy Specimen Among Those With PSA Relapse at 2 and 3 Years as Compared to Those Without PSA Relapse at the Primary Endpoint.   [ Time Frame: 2 and 3 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Andrew J. Armstrong, MD ScM FACP
Organization: DukeUMC
phone: (919) 668-8797
e-mail: andrew.armstrong@duke.edu



Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00734851     History of Changes
Other Study ID Numbers: Pro00010747
First Submitted: August 13, 2008
First Posted: August 14, 2008
Results First Submitted: September 21, 2015
Results First Posted: December 23, 2015
Last Update Posted: December 23, 2015