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BACKGROUND: Multiparametric magnetic resonance imaging (mpMRI) has an established role for the diagnosis of clinically significant prostate cancer (sPCa). The PRIMARY trial demonstrated that [68Ga]Ga-PSMA-11 positron emission tomography/computed tomography (PET/CT) was associated with a significant improvement in sensitivity and negative predictive value for sPCa detection. OBJECTIVE: To demonstrate that addition of prostate-specific membrane antigen (PSMA) radioligand PET/CT will enable some men to avoid transperineal prostate biopsy without missing sPCa, and will facilitate biopsy targeting of PSMA-avid sites. DESIGN, SETTING, AND PARTICIPANTS: This multicentre, two-arm, phase 3, randomised controlled trial will recruit 660 participants scheduled to undergo biopsy. Eligible participants will have clinical suspicion of sPCa with a Prostate Imaging-Reporting and Data System (PI-RADS) score of 2 and red flags, or a PI-RADS score of 3 on mpMRI (PI-RADS v2). Participants will be randomised at a 1:1 ratio in permuted blocks stratified by centre. The trial is registered on ClinicalTrials.gov as NCT05154162. INTERVENTION: In the experimental arm, participants will undergo pelvic PSMA PET/CT. Local and central reviewers will interpret scans independently using the PRIMARY score. Participants with a positive result will undergo targeted transperineal prostate biopsies, whereas those with a negative result will undergo prostate-specific antigen monitoring alone. In the control arm, all participants undergo template transperineal prostate biopsies. Participants will be followed for subsequent clinical care for up to 2 yr after randomisation. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: sPCa is defined as Gleason score 3 + 4 (≥10%) = 7 disease (grade group 2) or higher on transperineal prostate biopsy. Avoidance of transperineal prostate biopsy will be measured at 6 mo from randomisation. The primary endpoints will be analysed on an intention-to-treat basis. CONCLUSIONS: Patient enrolment began in March 2022, with recruitment expected to take 36 mo. PATIENT SUMMARY: For patients with suspected prostate cancer who have nonsuspicious or unclear MRI (magnetic resonance imaging) scan findings, a different type of scan (called PSMA PET/CT; prostate-specific membrane antigen positron emission tomography/computed tomography) may identify men who could avoid an invasive prostate biopsy. This type of scan could also help urologists in better targeting of samples from suspicious lesions during prostate biopsies.
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PURPOSE: Ultrasound measurement of bladder wall thickness has been proposed as a useful diagnostic parameter in patients with bladder outlet obstruction and other voiding dysfunctions. We assessed bladder wall thickness measurement as a noninvasive test in patients with suspected bladder outlet obstruction or overactive bladder syndrome. MATERIALS AND METHODS: Transabdominal ultrasound measurement of bladder wall thickness was performed during urodynamic study in 180 patients with nonneurogenic voiding dysfunction. Two measurements of anterior bladder wall thickness, 1 cm apart in the midline and averaged, were obtained at 200 ml filling. Bladder wall thickness findings were correlated with urodynamic diagnoses. RESULTS: A total of 180 patients with an average age of 62 years (range 20 to 94) were recruited, comprising 73 males and 107 females. Of the patients 69 had normal urodynamics, 39 had bladder outlet obstruction, 38 had increased bladder sensation on cystometry and 34 had detrusor overactivity. Bladder wall thickness was 1.1 to 4.5 mm in all groups. Males had a slightly thicker bladder wall than females (mean 2.1 vs 1.9 mm, p = 0.064). Mean bladder wall thickness in patients with normal urodynamics, bladder outlet obstruction, detrusor overactivity and increased bladder sensation was 2.0, 2.1, 1.9 and 1.8 mm, respectively. No significant difference was found between the groups (ANOVA p = 0.064, not significant). In particular there was no difference in bladder wall thickness between patients with normal urodynamics, and those with bladder outlet obstruction (p = 0.31) or detrusor overactivity (p = 0.309). CONCLUSIONS: Bladder wall thickness is remarkably uniform in patients with nonneurogenic voiding dysfunction. Therefore, it cannot reliably predict bladder outlet obstruction or detrusor overactivity. Bladder wall thickness measurement does not provide an alternative to urodynamic studies for diagnosing voiding dysfunction.