To evaluate and compare PSA-glycosylation patterns in semen of prostate cancer patients and healthy controls.To correlate PSA-glycosylation patterns in semen with pathological tumour stage and Gleason grade in prostate cancer patients.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- PSA-glycosylation patterns (finger-prints) for prostate cancer versus normal
controls
- Correlation between PSA-glycosylation patterns and Gleason grade/tumour stage
(clinical and pathological)
Secondary outcome
Correlation between PSA-glycosylation patterns and PSA-level in serum
Background summary
Recently we have built up a workflow, which allows us to purify seminal PSA
from individual donors, starting with a reasonably small amount (3-5 mL) of
semen sample. Using an in-house developed high resolution native Mass
Spectrometry platform, we are able to characterize intact PSA including its
molecular heterogeneity, in a qualitative and quantitative manner. From these
preliminary data we conclude that it is well-intentioned to apply this novel
strategy on PCa samples, to detect the changes of glycosylation profiles at the
intact PSA level. It has been hypothesized that PSA-glycosylation patterns in
semen can be related to the presence of prostate cancer and these specific
PSA-glycosylation patterns can be correlated with high-grade and high-risk
prostate cancer.
Study objective
To evaluate and compare PSA-glycosylation patterns in semen of prostate cancer
patients and healthy controls.
To correlate PSA-glycosylation patterns in semen with pathological tumour stage
and Gleason grade in prostate cancer patients.
Study design
This is an observational study to analyse PSA-glycosylation patterns in the
semen of prostate cancer patients and to compare these outcomes with healthy
controls. All patients with biopsy-proven prostate cancer, who are being
scheduled for robot-assisted laparoscopic prostatectomy may be included in this
study. Healthy controls will be recruited from the outpatient clinic of the
Department of Urology. The healthy controls will be patients with lower urinary
symptoms (LUTS), a non-suspicious serum PSA-level (PSA < 3.0 ng/ml) and no
suspicion for prostate cancer on digital rectal examination and transrectal
ultrasound.
Study burden and risks
The risks of participation in this study are negligible. The benefit may be
that by determining these PSA-glycosylation patterns in the semen, prostate
cancer may be detected at an earlier stage. The PSA-glycosylation may also be
indicative for aggressiveness of the disease, thus guiding clinical
decision-making in prostate cancer.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for patients:
-Male gender
-Signed written informed consent
-Biopsy-proven prostate cancer, eligible for surgery
-Age 55 - 70 years
-Willing and able to collect semen;Inclusion criteria for controls:
-Male gender
-Visiting the outpatient clinic because of lower urinary tract symptoms (LUTS)
-Signed written informed consent
-Serum PSA < 3.0 ng/ml
-No suspicion for prostate cancer on digital rectal examination and transrectal ultrasound as judged by the urologist
-Willing and able to collect semen
Exclusion criteria
-Urinary tract infection
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50841.041.15 |