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Trial record 56 of 1543 for:    Androgens

Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat 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: NCT00924807
Recruitment Status : Terminated (Sponsor closed the trial)
First Posted : June 19, 2009
Results First Posted : March 17, 2015
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Beth Israel Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: Leuprolide acetate, Bicalutamide, Sorafenib
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Androgen Depr, Radiotherapy, Sorafenib
Hide Arm/Group Description

Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.

Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg

Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title Androgen Depr, Radiotherapy, Sorafenib
Hide Arm/Group Description

Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.

Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg

Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
  50.0%
>=65 years
2
  50.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants
66.25
(61 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
0
   0.0%
Male
4
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
Gleason 7 histology, or PSA 10-20   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants
4
[1]
Measure Description:

Prostate cancers are commonly graded using Gleason score or pattern. Gleason grading is based on a 5-component system, based on 5 histologic patterns.

Cancers with a Gleason score of 7 may be called moderately differentiated or intermediate grade.

Prostate-Specific Antigen (PSA) a protein that is produced by the prostate gland. The higher a man’s PSA level, the more likely it is that he has prostate cancer. Most doctors considered PSA levels of 4.0 ng/mL and lower as normal.

1.Primary Outcome
Title Determine the Safety and Maximally Tolerated Dose of Sorafenib Administered Concurrently With Radiotherapy in the Treatment of Intermediate- and High-risk Localized Prostate Cancer.
Hide Description Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.
Time Frame Day 29 and every 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.
Arm/Group Title Androgen Depr, Radiotherapy, Sorafenib
Hide Arm/Group Description:

Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.

Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Biochemical Disease-free Survival
Hide Description Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study.
Time Frame after 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
data not collected
Arm/Group Title Androgen Depr, Radiotherapy, Sorafenib
Hide Arm/Group Description:

Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.

Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 18 months
Adverse Event Reporting Description Adverse Events were assessed by regular investigator assessment, regular laboratory testing
 
Arm/Group Title Androgen Depr, Radiotherapy, Sorafenib
Hide Arm/Group Description

Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.

Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg

All-Cause Mortality
Androgen Depr, Radiotherapy, Sorafenib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Androgen Depr, Radiotherapy, Sorafenib
Affected / at Risk (%) # Events
Total   0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Androgen Depr, Radiotherapy, Sorafenib
Affected / at Risk (%) # Events
Total   4/4 (100.00%)    
Cardiac disorders   
Hypertension  1  3/4 (75.00%)  3
Endocrine disorders   
Hot flashes  1  1/4 (25.00%)  1
Eye disorders   
Ocular-Amaurosis fugax  1  1/4 (25.00%)  1
Gastrointestinal disorders   
Diarrhea  1  1/4 (25.00%)  1
Flatulence  1  2/4 (50.00%)  2
Proctitis  1  1/4 (25.00%)  1
Renal and urinary disorders   
Urinary frequency/urgency  1  4/4 (100.00%)  4
Urinary retention  1  1/4 (25.00%)  1
dysuria  1  3/4 (75.00%)  3
Skin and subcutaneous tissue disorders   
Hand-and-foot syndrome  1  2/4 (50.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, NCI-CTC version 3.0
Data of zero ("0") participants were analyzed due to lack of funding and prematurely terminating the study by sponsor. All subjects are following up in the clinic off the study. Early termination leading to small number of subjects analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Seth Cohen, MD
Organization: St. Luke's Roosevelt Hospital Center
Phone: 212-523-7289
EMail: secohen@chpnet.org
Layout table for additonal information
Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT00924807     History of Changes
Other Study ID Numbers: IRB# 004-08
SR06-959
First Submitted: June 17, 2009
First Posted: June 19, 2009
Results First Submitted: January 13, 2015
Results First Posted: March 17, 2015
Last Update Posted: December 11, 2018