Clinical trial NCT06584279: Diagnostic Value of MRI-targeted Plus Index-lesion-ipsilaterally Systematic Biopsy for Biopsy-naive Men At Risk of Prostate Cancer
Official title: Diagnostic Value of MRI-targeted Plus Index-lesion-ipsilaterally Systematic Biopsy for Biopsy-naive Men At Risk of Prostate Cancer: a Prospective, Multicenter, Paired, Non-inferiority Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 563
Sex: MALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: biopsy-naive men at risk of prostate cancer

Brief summary: Targeted and systematic biopsy stands as the prevalent diagnostic approach for prostate cancer. Despite its widespread use, this method is characterized by a high volume of needle biopsies. A refined approach, termed targeted and index-lesion-ipsilateral systematic biopsy, as one of targeted and regional systematic biopsy methods, aim to reduce the number of biopsy cores while maintaining an adequate positive rate. However, the absence of robust evidence necessitates further investigation. This study employs a prospective, multicenter, paired, non-inferiority design to assess the diagnostic efficacy of targeted and index-lesion-ipsilateral systematic prostate biopsy in comparison with the conventional targeted and systematic biopsy for the detection of clinically significant prostate cancer (csPCa). Eligible participants were identified as those with target lesions on prostate MRI, who subsequently underwent targeted and systematic prostate biopsies. The index lesion was defined as the one with the highest Prostate Imaging Reporting and Data System (PI-RADS) score; in cases of multiple lesions with identical PI-RADS scores, the lesion with the greatest diameter was prioritized. Post-biopsy pathological data were collected and evaluated using the International Society of Urological Pathology (ISUP) grading system, which classifies patients with a grade of 2 or higher as having csPCa. The study's primary outcome was to calculate the confidence interval for the difference in csPCa detection rates between the two biopsy methods under a paired design. This interval was then compared against a pre-specified non-inferiority margin to determine whether the targeted and index-lesion-ipsilateral systematic biopsy method is non-inferior to the standard targeted and systematic biopsy in detecting csPCa.


Eligibility criteria: Inclusion Criteria:

* Prostate specific antigen (PSA) \>4 ng/ml;
* Prostate Imaging-Reporting and Data System (PI-RADS) score of any lesions on prostate magnetic resonance imaging ≥4 or PI-RADS score of lesions on prostate magnetic resonance imaging = 3 and prostate specific antigen density ≥0.1ng/cm3;
* accept prostate biopsy;

Exclusion Criteria:

* Prostate specific antigen\>20ng/ml；
* the location of index lesion on prostate MRI is on the midline of the prostate and symmetrical on both sides;
* any contraindication of prostate biopsy;
* Previous prostate biopsy；
* Previous history of androgen deprivation therapy (ADT), pelvic radiotherapy, and other treatments；
* Previous history of transurethral prostatectomy (TURP)；

Primary outcomes:
measure: Confidence interval for the difference in csPCa detection rate between targeted + index-lesion-ipsilaterally systematic biopsy and targeted + systematic biopsy for biopsy-naive men at risk of prostate cancer
timeFrame: 0.5-1 years
Secondary outcomes:
measure: additional value of index-lesion-contralaterally systematic biopsy
timeFrame: 0.5-1 years
measure: pathological upgrade after radical prostatectomy
timeFrame: 0.5-1 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study officials:
References: