Trial Outcomes & Findings for Zinc/PSA Ratio as a Novel Biomarker for Prostate Cancer Detection (NCT NCT02013180)
NCT ID: NCT02013180
Last Updated: 2019-04-16
Results Overview
Does the zinc/PSA ratio show statistically signifacant difference in patients with prostate cancer?
Recruitment status
COMPLETED
Target enrollment
480 participants
Primary outcome timeframe
measurement of serum zinc and PSA levels are performed prior to transrectal prostat biopsy; pathologic evaluation of biopsy specimens are performed within 2-3 weeks
Results posted on
2019-04-16
Participant Flow
Participant milestones
| Measure |
Prostate Cancer
prostate adenocarcinoma in pathologic evaluation
|
Control
benign prostatic diseases in pathologic evaluation
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
361
|
|
Overall Study
COMPLETED
|
119
|
361
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Prostate Cancer
n=119 Participants
prostate adenocarcinoma in pathologic evaluation
|
Control
n=361 Participants
benign prostatic diseases in pathologic evaluation
|
Total
n=480 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
0 Participants
n=119 Participants
|
0 Participants
n=361 Participants
|
0 Participants
n=480 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=119 Participants
|
361 Participants
n=361 Participants
|
480 Participants
n=480 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Turkey
|
119 participants
n=119 Participants
|
361 participants
n=361 Participants
|
480 participants
n=480 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=119 Participants
|
0 Participants
n=361 Participants
|
0 Participants
n=480 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=119 Participants
|
177 Participants
n=361 Participants
|
215 Participants
n=480 Participants
|
|
Age, Categorical
>=65 years
|
81 Participants
n=119 Participants
|
184 Participants
n=361 Participants
|
265 Participants
n=480 Participants
|
|
Age, Continuous
|
68.39 years
STANDARD_DEVIATION 9 • n=119 Participants
|
64.19 years
STANDARD_DEVIATION 7.53 • n=361 Participants
|
65.23 years
STANDARD_DEVIATION 8.1 • n=480 Participants
|
PRIMARY outcome
Timeframe: measurement of serum zinc and PSA levels are performed prior to transrectal prostat biopsy; pathologic evaluation of biopsy specimens are performed within 2-3 weeksDoes the zinc/PSA ratio show statistically signifacant difference in patients with prostate cancer?
Outcome measures
| Measure |
Prostate Cancer
n=119 Participants
prostate adenocarcinoma in pathologic evaluation
|
Control
n=361 Participants
benign prostatic diseases in pathologic evaluation
|
|---|---|---|
|
Assesment of Serum Zinc/PSA Ratio in Patients With Prostate Cancer and Benign Prostatic Diseases
|
150.8 ratio
Interval 51.8 to 264.1
|
239.6 ratio
Interval 145.1 to 357.7
|
Adverse Events
Prostate Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Dr. Mustafa Zafer Temiz
Catalca Ilyas Cokay State Hospital
Phone: +90 212 787 19 12
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place