Trial Outcomes & Findings for Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer (NCT NCT01220973)

NCT ID: NCT01220973

Last Updated: 2018-06-08

Results Overview

PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2018-06-08

Participant Flow

Subjects were recruited through the Rutgers Cancer Institute of New Jersey Oncology Group. The study was open to accrual on 02/25/2009 and closed to accrual on 11/13/2012.

We are reporting results on 27 eligible patients. Seven patients were deemed ineligible.

Participant milestones

Measure	Atorvastatin and Celecoxib atorvastatin calcium celecoxib laboratory biomarker analysis
Overall Study STARTED	27
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Atorvastatin Calcium and Celecoxib in Treating Patients With Rising PSA Levels After Local Therapy for Prostate Cancer

Baseline characteristics by cohort

Measure	Atorvastatin and Celecoxib n=27 Participants atorvastatin calcium celecoxib laboratory biomarker analysis
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: A total of 27 patients were enrolled but only 26 were evaluable as one patient withdrew consent prior to starting therapy.

PSA response was defined as a decrease in slope of at least 25%, when log (PSA) is plotted vs. time.

Outcome measures

Measure	Atorvastatin and Celecoxib n=26 Participants atorvastatin calcium celecoxib laboratory biomarker analysis
PSA Response	14 Participants

Adverse Events

Atorvastatin and Celecoxib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Susan Goodin PharmD, FCCP, BCOP

Rutgers Cancer Institute of New Jersey

Phone: 732-235-6783

Email: goodin@cinj.rutgers.edu

Results disclosure agreements

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