Trial Outcomes & Findings for Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer (NCT NCT00006101)

NCT ID: NCT00006101

Last Updated: 2018-05-14

Results Overview

Difference refers to absolute difference of 12 months to baseline and % relative difference refers to the ratio of the absolute difference divided by the baseline times 100.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 76 participants
• Primary outcome timeframe: Baseline and 12 months
• Results posted on: 2018-05-14

Participant Flow

Participant milestones

Measure	Eflornithine 500mg/d for 12 months eflornithine: Take 500mg of eflornithine (Difluoromethylornithine) per day for 12 months	Placebo placebo for 12 months Placebo: Take placebo per day for 12 months
Overall Study STARTED	38	38
Overall Study COMPLETED	33	33
Overall Study NOT COMPLETED	5	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Eflornithine in Treating Patients At High Risk of Developing Prostate Cancer

Baseline characteristics by cohort

Measure	Eflornithine n=38 Participants 500mg/d for 12 months eflornithine: Take 500mg of DFMO per day for 12 months	Placebo n=38 Participants placebo for 12 months Placebo: Take placebo per day for 12 months	Total n=76 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	38 Participants n=7 Participants	76 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	38 participants n=7 Participants	76 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: The results reported include all men with both an entrance and exit biopsy, regardless of cancer status.

Difference refers to absolute difference of 12 months to baseline and % relative difference refers to the ratio of the absolute difference divided by the baseline times 100.

Outcome measures

Measure	Eflornithine n=34 Participants 500mg/d for 12 months eflornithine: Take 500mg of DFMO per day for 12 months	Placebo n=33 Participants placebo for 12 months Placebo: Take placebo per day for 12 months
Change in Total PSA, Percent Free PSA, and Prostate Volume at 12 Months Prostate Volume	0.94 Relative % difference Standard Deviation 17.58	11.14 Relative % difference Standard Deviation 19.44
Change in Total PSA, Percent Free PSA, and Prostate Volume at 12 Months Total PSA	-0.75 Relative % difference Standard Deviation 26.29	1.55 Relative % difference Standard Deviation 38.29
Change in Total PSA, Percent Free PSA, and Prostate Volume at 12 Months Percent Free PSA	10.21 Relative % difference Standard Deviation 44.39	4.89 Relative % difference Standard Deviation 40.14

Adverse Events

Eflornithine

Serious events: 4 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Eflornithine n=38 participants at risk 500mg/d for 12 months eflornithine: Take 500mg of DFMO per day for 12 months	Placebo n=38 participants at risk placebo for 12 months Placebo: Take placebo per day for 12 months
Reproductive system and breast disorders Prostate Cancer Diagnosis	7.9% 3/38 • Through study completion, an average of 1 year	2.6% 1/38 • Through study completion, an average of 1 year
Surgical and medical procedures Knee Replacement	2.6% 1/38 • Through study completion, an average of 1 year	0.00% 0/38 • Through study completion, an average of 1 year

Other adverse events

Measure	Eflornithine n=38 participants at risk 500mg/d for 12 months eflornithine: Take 500mg of DFMO per day for 12 months	Placebo n=38 participants at risk placebo for 12 months Placebo: Take placebo per day for 12 months
Musculoskeletal and connective tissue disorders Muscular skeletal complaints	18.4% 7/38 • Through study completion, an average of 1 year	5.3% 2/38 • Through study completion, an average of 1 year
Nervous system disorders Hearing Related Complaints	13.2% 5/38 • Through study completion, an average of 1 year	15.8% 6/38 • Through study completion, an average of 1 year
Skin and subcutaneous tissue disorders Rash	0.00% 0/38 • Through study completion, an average of 1 year	2.6% 1/38 • Through study completion, an average of 1 year
General disorders Chest Pain	0.00% 0/38 • Through study completion, an average of 1 year	2.6% 1/38 • Through study completion, an average of 1 year
General disorders Vomiting	0.00% 0/38 • Through study completion, an average of 1 year	2.6% 1/38 • Through study completion, an average of 1 year
Reproductive system and breast disorders Sexual Difficulties	7.9% 3/38 • Through study completion, an average of 1 year	5.3% 2/38 • Through study completion, an average of 1 year
Gastrointestinal disorders Gastrointestinal Side Effects	10.5% 4/38 • Through study completion, an average of 1 year	10.5% 4/38 • Through study completion, an average of 1 year
General disorders Flu or cold symptoms	2.6% 1/38 • Through study completion, an average of 1 year	2.6% 1/38 • Through study completion, an average of 1 year

Additional Information

Dr. Thomas Ahlering

University of California, Irvine

Phone: (714) 456-6068

Email: tahlerin@uci.edu

Results disclosure agreements

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