No registrations found.
ID
Source
Brief title
Health condition
Prostate Cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
- How many prostate cancers are found using a 12-biopsy protocol compared to an 8-biopsy protocol.
- How many cancers are found in repeated biopsies after using a 12-biopsy protocol compared to an 8-biopsy protocol
- What % of cancers is found in the transition zone only in repeated biopsies after using a 12-biopsy protocol compared to an 8-biopsy protocol
Secondary outcome
- How do the primary outcomes relate to patient characterisics such as age, PSA, PSA-ratio, complexed PSA, symptoms.
- How many more complications occur in a 12 biopsy-protocol compared to an 8- biopsy protocol.
Background summary
Patients scheduled for prostate biopsies were randomized in the group of 8 ultrasound-guided transrectal biopsies or in the group with 12 ultrasound-guided transrectal biopsies to determine the incremental detection and complication rate using the two biopsy protocols and in repeated biopsies and to identify subgoups in which repeat biopsies can be safely omitted.
Study objective
More early stage cancers (T1,T2) will be found by increasing the number of biopsies per session and lowering the PSA cutt off values.
Study design
2 years
Intervention
All biopsies will be taken in the left lateral decubitus position.
Group 1:
8 ultrasound-guided transrectal biopsies, laterally aimed in the peripheral zone: one from the apex, two from the middle and one from the base on each side.
Group 2:
12 biopsies including 6 parasaggital cores and 6 lateral cores, one from the apex, one from the middle and one from the base on each side of the prostate.
P.O. Box 22660
S.A. Zaaijer
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5666030
S.A.Zaaijer@amc.uva.nl
P.O. Box 22660
S.A. Zaaijer
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5666030
S.A.Zaaijer@amc.uva.nl
Inclusion criteria
1. Age < 50 and PSA > 1,24 ng/ml
2. Age > 49 < 60 and PSA > 2,24 ng/ml
3. Age > 59 <70 and PSA > 2,24 ng/ml
4. Age >69 and PSA > 3,24 ng/ml
5. Abnormal DRE
6. Abnormal TRUS
Exclusion criteria
1. Age < 18
2. Proven prostate cancer
3. Clinical prostatitis < 1 month ago
4. Acute urinary retention < 1 month ago
5. PSA altering medicine (finasteride, dutasteride) used in the last 6 months
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 |
|---|---|
| NTR-new | NL1319 |
| NTR-old | NTR1368 |
| Other | MEC : 04/079 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |