Trial Outcomes & Findings for Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer (NCT NCT00860158)

NCT ID: NCT00860158

Last Updated: 2018-03-14

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2018-03-14

Participant Flow

Participant milestones

Measure	Experimental Arm Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days). Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Experimental Arm Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days). Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.

Overall Study Study Terminated

1

Baseline Characteristics

Neoadjuvant Dasatinib Plus LHRH Analogue Therapy in High-Risk Localized Prostate Cancer

Baseline characteristics by cohort

Measure	Experimental Arm n=1 Participants Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days). Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Region of Enrollment United States	1 participants n=93 Participants

PRIMARY outcome

Timeframe: 18 months

Population: No participants were analyzed for pCR due to study termination

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Population: Data for this secondary objective was not collected or analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 18 months

Outcome measures

Outcome data not reported

Adverse Events

Single Arm Assignment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Single Arm Assignment n=1 participants at risk Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days). Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose.
Gastrointestinal disorders DIARRHEA	100.0% 1/1 • Number of events 1
General disorders FATIGUE (ASTHENIA, LETHARGY, MALAISE)	100.0% 1/1 • Number of events 1
Gastrointestinal disorders NAUSEA	100.0% 1/1 • Number of events 1
Gastrointestinal disorders TASTE ALTERATION (DYSGEUSIA)	100.0% 1/1 • Number of events 1

Additional Information

Principal Investigator

Hoosier Cancer Research Network, Inc.

Phone: 317-921-2050

Email: jsmith@hoosiercancer.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place