To apply a novel blood assay to 150 patients undergoing a radical prostatectomy in order to assess whether this test can accurately identify indolent cancers and thereby prevent unnecessary treatments. To increase the accuracy of the flow cytometric…
ID
Source
Brief title
Condition
- Reproductive and genitourinary neoplasms gender unspecified NEC
- Prostatic disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The difference in the number of activated PSA positive macrophages
(preoperatively) between patients with significant and insignificant cancers
(insignificant defined as < 0.5 ml of cancer, no Gleason pattern 4 or 5, no
extraprostatic extension, no seminal vesicle invasion, no lymph node metastasis
and absence of positive surgical margins).
Secondary outcome
- The difference in the number of activated PSA positive macrophages (at 1
week, 6 weeks and 6 months postoperatively) between patients with significant
and insignificant cancers.
- The difference in the number of activated PSA positive macrophages
(preoperatively, or at 1 week, 6 weeks, 6 months postoperatively) between
patients with biochemical recurrence (serum PSA at 3 months and 1 year
postoperatively > 0.2 ng/ml)
Background summary
Prostate cancer is the most prevalent malignancy in males in the Western world
and the second leading cause of male cancer death. The number of diagnosed
prostate cancers is rising due to PSA (prostate specific antigen) testing in
the population. The majority of the detected cancers will not effect survival.
However, at present these indolent cancers cannot be identified accurately,
which leads to unnecessary treatment in 30-50% of cases (radical prostatectomy
or radiotherapy). Apart from health care costs, this treatment is associated
with important side effects (erectile dysfunction and incontinence).
Consequently, there is an urgent need to improve the selection of patients for
invasive therapies.
Recently a multi-parameter flow cytometric test has been developed which
detects circulating macrophages with intracellular PSA, which are assumed to be
tissue macrophages derived from the prostate. A strong correlation has been
found between the number of circulating PSA-positive macrophages and prostate
cancer tumour stage.
Study objective
To apply a novel blood assay to 150 patients undergoing a radical prostatectomy
in order to assess whether this test can accurately identify indolent cancers
and thereby prevent unnecessary treatments. To increase the accuracy of the
flow cytometric assay, we aim to incorporate additional antibodies against
tumor-specific proteins.
Study design
This study is a prospective, invasive, observational study.
Study burden and risks
The burden for the patients exists of taking a total of 8 blood samples during
4 blood withdrawals. 3 times the blood will be taken during a regular blood
withdrawal, for 1 blood withdrawal an extra puncture will take place. The
burden and risks are thus minimal.
Postbus 2040
3000 CA Rotterdam
NL
Postbus 2040
3000 CA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- Men >= 18 years
- Histological confirmed adenocarcinoma of the prostate
- Localized prostate cancer
- Scheduled for radical prostatectomy
- Given informed consent
Exclusion criteria
- Metastatic disease
- Patient not able to understand the patient information
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 | NL25782.078.08 |