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Prostate cancer: which patients need (repeated) prostate biopsies and how many biopsies do they need?


- candidate number3557
- NTR NumberNTR1368
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jul-2008
- Secondary IDs04/079  MEC
- Public TitleProstate cancer: which patients need (repeated) prostate biopsies and how many biopsies do they need?
- Scientific TitleProstate cancer: which patients need (repeated) prostate biopsies and how many biopsies do they need?
- ACRONYM8 versus 12 prostate biopsies
- hypothesisMore early stage cancers (T1,T2) will be found by increasing the number of biopsies per session and lowering the PSA cutt off values.
- Healt Condition(s) or Problem(s) studiedProstate cancer, Prostatic neoplasms, Biopsy
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 22-okt-2004
- planned closingdate1-mrt-2008
- Target number of participants400
- InterventionsAll 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.
- 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.
- Timepoints2 years
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES S.A. Zaaijer
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.J.M.C.H. Rosette, de la
- Sponsor/Initiator Academic Medical Center (AMC), Department of Urology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryPatients 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.
- Main changes (audit trail)
- RECORD7-jul-2008 - 25-jul-2008


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