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Trial registered on ANZCTR


Trial ID
ACTRN12613000716763
Ethics application status
Approved
Date submitted
22/06/2013
Date registered
1/07/2013
Date last updated
1/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of prostatic specific antigen (PSA) before and after prostate biopsy. Could this change define the existence of prostate cancer?
Scientific title
PSA change ratio before and after prostate biopsy. Can it predict the need of repeat biopsy?
Secondary ID [1] 282719 0
Nil
Universal Trial Number (UTN)
Trial acronym
PSABAPB (PSA Before and After Prostate Biopsy)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 289439 0
Condition category
Condition code
Cancer 289766 289766 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transrectal ultrasound guided prostate biopsy. A transrectal ultrasound-guided prostate biopsy is a procedure that takes small samples of tissue from prostate gland with the aid of transrectal ultrasound probe. The procedure usually takes 10 to 15 minutes.
Intervention code [1] 287379 0
Diagnosis / Prognosis
Intervention code [2] 287380 0
Early detection / Screening
Comparator / control treatment
Single group trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289851 0
Estimate the PSA change ratio before and after prostate biopsy between two groups of patients. Based on the result of biopsy group A is comprised of patients with benign prostate hyperplasia while group B is comprised of patients with prostate cancer.
Timepoint [1] 289851 0
PSA is going to be measured one day before prostate biopsy and one hour after the last biopsy core. The PSA change ratio is defined as the ratio of post-biopsy total serum PSA to pre-biopsy serum PSA.
Secondary outcome [1] 303382 0
To investigate if this change ratio could be a predictive factor of prostate cancer diagnosed in a repeat biopsy.
Timepoint [1] 303382 0
This is going to be assessed in the follow-up of patients. Due to clinical suspicion of prostate cancer (Positive DRE, PSA, PSA velocity and PSA doubling-time) some patients (group A) are going to undergo a repeat biopsy. The result of the repeat biopsy (if and when will be done) is going to be associated with the previous biopsy PSA change ratio.
Secondary outcome [2] 303383 0
To investigate the ratio of urethral position among 9 different positions in the transverse section of prostate during TRUS (middle center / middle up / middle down / right up / right center / right down / left up / left center / left down). To achieve better visualization of urethral position in this section, a foley catheter is going to be used in all patients.
Timepoint [2] 303383 0
This is going to be assessed during the TRUS guided prostate biopsy.
Secondary outcome [3] 303384 0
To estimate the complications after prostate biopsy using the modified Clavien – Dindo system.
Timepoint [3] 303384 0
The timepoints of evaluation is during the period of one month following prostate biopsy.
Secondary outcome [4] 303513 0
To investigate LUTS (Lower Urinary Tract Symptoms) before and after prostate biopsy using IPSS (International Prostate Symptom Score) questionnaire and Qmax from Uroflow.
Timepoint [4] 303513 0
One hour before prostate biopsy and one month later

Eligibility
Key inclusion criteria
Serum PSA > 4 ng/ml or abnormal DRE findings
Minimum age
35 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Antiplatelet or anticoagulant medication <5 days before prostate biopsy
Bleeding disorder
Active UTI
Recent urethra catheterization due to acute retention (< 1 month)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5159 0
Greece
State/province [1] 5159 0

Funding & Sponsors
Funding source category [1] 287492 0
Self funded/Unfunded
Name [1] 287492 0
Address [1] 287492 0
Country [1] 287492 0
Primary sponsor type
Hospital
Name
Gennimatas General Hospital of Thessaloniki
Address
41 Ethnikis Aminis, Thessaloniki, 54643
Country
Greece
Secondary sponsor category [1] 286231 0
None
Name [1] 286231 0
Address [1] 286231 0
Country [1] 286231 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Prostate biopsy is the most useful diagnostic procedure for prostate cancer. We are going to estimate the PSA change ratio before and after prostate biopsy between two groups of patients. Based on the result of biopsy group A is comprised of patients with benign prostate hyperplasia while group B is comprised of patients with prostate cancer. According to the results we will try to find out new prognostic markers in order to predict which of our patients with negative cancer results in the biopsy are the best candidates for a repeat biopsy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40974 0
Dr Ioannidis Stavros
Address 40974 0
41 Ethnikis Aminis Street, Thessaloniki, 54643 . 1st urologic department of Gennimatas General Hospital of Thessaloniki.
Country 40974 0
Greece
Phone 40974 0
+302310963104
Fax 40974 0
Email 40974 0
stavros.ioannidis68@gmail.com
Contact person for public queries
Name 40975 0
Dr Kampantais Spyridon
Address 40975 0
41 Ethnikis Aminis Street, Thessaloniki, 54643. 1st urologic department of Gennimatas General Hospital of Thessaloniki
Country 40975 0
Greece
Phone 40975 0
+302310963105
Fax 40975 0
Email 40975 0
kabspir@hotmail.com
Contact person for scientific queries
Name 40976 0
Dr Kampantais Spyridon
Address 40976 0
41 Ethnikis Aminis Street, Thessaloniki, 54643. 1st urologic department of Gennimatas General Hospital of Thessaloniki.
Country 40976 0
Greece
Phone 40976 0
+302310963105
Fax 40976 0
Email 40976 0
kabspir@hotmail.com