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Trial record 52 of 121 for:    prostate cancer AND prostate cancer screening | ( Map: United States )

Utilizing A Genomic Sig for "BRCAness" to Eval the Efficacy of Satraplatin in Men With Met. Castration Resistant Prostate Ca

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ClinicalTrials.gov Identifier: NCT01289067
Recruitment Status : Completed
First Posted : February 3, 2011
Results First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Prostate Cancer Foundation
Information provided by (Responsible Party):
William K. Oh, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Prostate Cancer
Intervention Drug: Satraplatin
Enrollment 13
Recruitment Details Recruitment began in December 2010. Thirteen (13) patients from Mount Sinai Medical Center were enrolled to the study between January 27, 2011 and March 7, 2013.
Pre-assignment Details  
Arm/Group Title Satraplatin, Single Arm
Hide Arm/Group Description Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Satraplatin, Single Arm
Hide Arm/Group Description Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
69
(54 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
0
   0.0%
Male
13
 100.0%
Metastasis site  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants
Bone only 6
Lymph Node only 4
Visceral only 0
Bone and Lymph Node 1
Bone and Visceral 3
Lymph Node and Visceral 1
Bone, Lymph Node, and Visceral 2
Gleason Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 13 participants
Gleason 7 4
Gleason 8 5
Gleason 9 4
[1]
Measure Description: Gleason scores range from 2 to 10, with 2 representing the most well-differentiated tumors and 10 the least-differentiated tumors. Least-differentiated tumors typically have a worse prognosis.
PSA   [1] 
Median (Full Range)
Unit of measure:  Ng/ml
Number Analyzed 13 participants
71.67
(0.04 to 3057)
[1]
Measure Description: pre-treatment PSA
1.Primary Outcome
Title Efficacy of Satraplatin as Second Line Therapy in Men With CRCP
Hide Description Patients with good tolerance of treatment who have a 30% PSA decline from their pre-treatment level within 3 months of treatment initiation will be considered responders provided objective tumor measurements are stable or also demonstrate response.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Satraplatin, Single Arm
Hide Arm/Group Description:
Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
responders 4
non-responders 6
not evaluable for response 3
2.Secondary Outcome
Title Number of Days to Maximum Decline in PSA
Hide Description Response rate - Maximum decline in PSA that occurs during treatment.
Time Frame baseline and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only responders included
Arm/Group Title Satraplatin, Single Arm
Hide Arm/Group Description:
Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
Overall Number of Participants Analyzed 4
Median (Full Range)
Unit of Measure: days
165.5
(68 to 236)
3.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Progression Free Survival is measured from the time of the initiation of therapy until the first date that recurrent or progressive disease is objectively documented. Progression is a composite endpoint that can be based upon PSA, objective measures of disease, symptoms or death. Time to disease progression.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Satraplatin, Single Arm
Hide Arm/Group Description:
Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: days
Responders
206
(73 to 356)
Nonresponders
35
(31 to 41)
4.Secondary Outcome
Title Overall Survival
Hide Description Patients followed for a minimum of 24 months or until death. Patients and/or their family members will be contacted via telephone calls or certified letter.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Satraplatin, Single Arm
Hide Arm/Group Description:
Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: days
Responders
570
(184 to 717)
Nonresponders
486
(147 to 644)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Satraplatin, Single Arm
Hide Arm/Group Description Satraplatin: Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
All-Cause Mortality
Satraplatin, Single Arm
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Satraplatin, Single Arm
Affected / at Risk (%)
Total   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Satraplatin, Single Arm
Affected / at Risk (%)
Total   10/13 (76.92%) 
Blood and lymphatic system disorders   
Leukopenia  3/13 (23.08%) 
Neutropenia  1/13 (7.69%) 
Thromboscytopenia  1/13 (7.69%) 
Gastrointestinal disorders   
Diarrhea  1/13 (7.69%) 
General disorders   
Fatigue  1/13 (7.69%) 
Dysphagia  2/13 (15.38%) 
Renal and urinary disorders   
Renal failure  1/13 (7.69%) 
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: Dr. Bobby Liaw
Organization: Icahn School of Medicine at Mount Sinai
Phone: (212) 604-6010
EMail: bobby.liaw@mountsinai.org
Layout table for additonal information
Responsible Party: William K. Oh, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01289067     History of Changes
Other Study ID Numbers: GCO 10-1222
Prostate Cancer Foundation ( Other Identifier: Prostate Cancer Foundation )
First Submitted: January 7, 2011
First Posted: February 3, 2011
Results First Submitted: January 10, 2017
Results First Posted: February 13, 2018
Last Update Posted: February 13, 2018