Suspected prostate cancer Cancer Malignant neoplasm of prostate
Conditions
Interventions
1042 biopsy-naïve men referred with suspected PCa on the basis of an elevated age-specific prostate-specific antigen (PSA) or abnormal digital rectal examination (DRE), and suitable for investigation
Sponsors
University of Oxford
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: All biopsy-naïve men who (regardless of age), during an investigation for suspicion of possible PCa, require a prostate biopsy and who have had one or more of the below findings: 1. A PSA value above the age-adjusted upper limit of normal, regardless of the MRI result 2. An abnormal pre-biopsy MRI 3. An abnormal prostate DRE (regardless of serum PSA or MRI result) 4. Considered suitable to tolerate a LATP biopsy procedure
Exclusion criteria
Exclusion criteria: 1. Had a previous prostate biopsy 2. Dysuria on the day of biopsy or untreated urinary tract infection (UTI) 3. Immunocompromised (due to history of prior immunocompromising medical condition, or medications e.g. steroids or methotrexate) 4. May need enhanced antibiotic prophylaxis (e.g. due to indwelling catheter or recurrent UTIs) 5. Previous abdominoperineal resection (i.e. absent rectum) 6. Unable to recline adequately in Lloyd-Davis / lithotomy position (e.g. hip surgery or contractures) 7. Unable to have a pre-biopsy MRI (e.g. pacemaker, eGFR 50 ng/ml (i.e. locally advanced/metastatic PCa easily detectable by TRUS)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically significant prostate cancer (PCa), defined as Gleason Grade Group =2, detected using LATP/TRUS biopsy within 5 days of the samples being taken | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rates of infection measured using patient-reported questionnaires at 7 and 35 days, and 4 months 2. Health-related quality of life measured using the validated questionnaires International Index for Erectile Function (IIEF), International Prostate Symptom Score (I-PSS), Expanded Prostate Cancer Index Composite (EPIC), bowel assessment, and EuroQol Group quality of life questionnaire (EQ-5D-5L) at 7 and 35 days, and 4 months 3. Patient-reported tolerability of the procedure measured using the Patient Reported Outcomes Burdens and Experiences (ProBE) questionnaire (perception part only) immediately after the procedure 4. Patient-reported biopsy-related complications (including bleeding, bruising, pain, and loss of erectile function) measured using the ProBE questionnaire at 1 week 5. Number of subsequent prostate biopsy procedures required measured using a patient diary that is collected and reviewed at 4 months 6. Cost-effectiveness measured using a trial specific resource questionnaire at baseline, 7, and 35 days, and 4 months 7. Histological parameters (ISUP grade group, cancer core length, core involvement ,and target biopsy cancer parameters) measured using standard NHS histology reporting of biopsy samples within 5 days of the samples being taken 8. Burden and rate of detection of clinically insignificant (Gleason Grade Group 1) PCa measured using standard NHS histology reporting of biopsy samples within 5 days of the samples being taken | — |
Countries
United Kingdom
Outcome results
None listed