Trial Outcomes & Findings for 3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer (NCT NCT01296672)

Last Updated: 2017-10-06

Results Overview

Pre/Post Ratio prediction area under the receiver operating characteristics curve (AUC) for subjects taking finasteride 5mg every day for 3 months. Measurements of PSA are measured from Baseline until 3 months.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

383 participants

Primary outcome timeframe

Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months

Results posted on

2017-10-06

Participant Flow

Participant milestones

Participant milestones
Measure	Finasteride Finasteride 5mg every day by mouth for 3 months	Placebo Placebo every day by mouth for 3 months
Overall Study STARTED	306	77
Overall Study COMPLETED	233	59
Overall Study NOT COMPLETED	73	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Finasteride Finasteride 5mg every day by mouth for 3 months	Placebo Placebo every day by mouth for 3 months
Overall Study Lost to Follow-up	73	18

Baseline Characteristics

3 Month Finasteride Challenge Test Can Significantly Improve the Performance of Screening for Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Finasteride n=306 Participants Finasteride 5mg tablets every day by mouth for 3 months Finasteride: Finasteride 5mg every day by mouth for 3 months	Placebo n=77 Participants Placebo 5mg tablet every day by mouth for 3 months Placebo: Placebo every day by mouth for 3 months	Total n=383 Participants Total of all reporting groups
Age, Continuous	65 years n=5 Participants	66 years n=7 Participants	65 years 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	306 Participants n=5 Participants	77 Participants n=7 Participants	383 Participants n=5 Participants
Race/Ethnicity, Customized Race · Non-Hispanic white	125 Participants n=5 Participants	31 Participants n=7 Participants	156 Participants n=5 Participants
Race/Ethnicity, Customized Race · Non-Hispanic black	42 Participants n=5 Participants	12 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized Race · Hispanic	134 Participants n=5 Participants	34 Participants n=7 Participants	168 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other race	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	306 participants n=5 Participants	77 participants n=7 Participants	383 participants n=5 Participants
Prostate Specific Antigen	5.2 ng/ml n=5 Participants	5.3 ng/ml n=7 Participants	5.2 ng/ml n=5 Participants

PRIMARY outcome

Timeframe: Reported at 90-days: assessment at baseline, 1 month, 2 months and 3 months

Population: Patients with biopsy

Outcome measures

Outcome measures
Measure	Finasteride n=233 Participants PSA Ratio AUC	Placebo n=59 Participants PSA Ratio AUC
Pre/Post Ratio PSA Area Under the Curve (AUC)	0.57 Ratio Interval 0.45 to 0.6	0.61 Ratio Interval 0.46 to 0.76

SECONDARY outcome

Timeframe: Reported at 90 days: assessed at baseline, 30 days, 60 days and 90-day

Population: Receiving biopsy

Area under the Receiver Operating Characteristic Curve (ROC-AUC) of the PCA3 (Prostate Cancer Antigen 3) to detect difference in PSA decline between cases and controls (non-cases)

Outcome measures

Outcome measures
Measure	Finasteride n=233 Participants PSA Ratio AUC	Placebo n=59 Participants PSA Ratio AUC
PCA3 (Prostate Cancer Antigen 3)Score AUC	0.65 ratio Interval 0.58 to 0.72	0.84 ratio Interval 0.73 to 0.96

SECONDARY outcome

Timeframe: Reported at 90 days: assessed at baseline, 30 days, 60 days, and 90 days

Population: Receiving biopsy

Area Under the Receiver Operating Characteristic Curve (ROC-AUC) of the T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score to Predict the Risk of Prostate Cancer

Outcome measures

Outcome measures
Measure	Finasteride n=233 Participants PSA Ratio AUC	Placebo n=59 Participants PSA Ratio AUC
T2:ERG ( A Gene on Chromosome 21q22.2 That Encodes an Androgen-regulated Transmembrane Serine Protease Ratio to Estrogen Related Gene) Score AUC	0.62 Ratio Interval 0.55 to 0.69	0.62 Ratio Interval 0.47 to 0.76

Adverse Events

Finasteride

Serious events: 3 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Finasteride n=306 participants at risk Finasteride 5mg every day by mouth for 3 months	Placebo n=77 participants at risk Placebo every day by mouth for 3 months
Skin and subcutaneous tissue disorders fulgurated skin lesions	0.00% 0/306	1.3% 1/77 • Number of events 1
Cardiac disorders Palpitations	0.33% 1/306 • Number of events 1	0.00% 0/77
Ear and labyrinth disorders Dizziness	0.33% 1/306 • Number of events 1	0.00% 0/77
Gastrointestinal disorders Abdominal pain	0.33% 1/306 • Number of events 1	0.00% 0/77

Other adverse events

Other adverse events
Measure	Finasteride n=306 participants at risk Finasteride 5mg every day by mouth for 3 months	Placebo n=77 participants at risk Placebo every day by mouth for 3 months
Skin and subcutaneous tissue disorders Rash	1.3% 4/306 • Number of events 4	0.00% 0/77
Reproductive system and breast disorders Decreased libido	0.98% 3/306 • Number of events 4	0.00% 0/77
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/306	1.3% 1/77 • Number of events 1
Gastrointestinal disorders Dehydration	0.00% 0/306	1.3% 1/77 • Number of events 1
Skin and subcutaneous tissue disorders Itch	0.33% 1/306 • Number of events 1	1.3% 1/77 • Number of events 1
Vascular disorders Stent placement	0.00% 0/306	1.3% 1/77 • Number of events 1
Cardiac disorders Syncope	0.00% 0/306	1.3% 1/77 • Number of events 1
Renal and urinary disorders Urinary tract infection	0.33% 1/306 • Number of events 1	1.3% 1/77 • Number of events 1

Additional Information

Jonathan Gelfond

UT Health

Phone: 210 567-0836

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60