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| Name | Class |
|---|---|
| Beijing Hospital | OTHER_GOV |
| Shanghai East Hospital | OTHER |
| Beijing Friendship Hospital | OTHER |
| Chinese People's Liberation Army (PLA) General Hospital |
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The goal of this multicenter randomized controlled trial (RCT) is to evaluate the efficacy of different prostate biopsy schemes, including perilesional biopsy (PB) and combination of systematic biopsy and targeted biopsy (TB+SB).
The main questions it aims to answer are:
Does PB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of PB and TB+SB to explore the efficacy of different prostate biopsy schemes.
Participants will:
Receive TB+PB or TB+SB.
Currently, combination of systematic biopsy and targeted biopsy (TB+SB) has been recommended for the diagnosis of patients with suspicious lesion found on magnetic resonance imaging (MRI). Although the combined biopsy approach could effectively detect clinically significant prostate cancer (csPCa), the increased number of biopsy cores would increase the risk of complications and decrease the postoperative quality of life. In recent years, urological and radiologic thinking has changed after realizing that systemic biopsies may be omitted when the chance of missing a clinically significant lesion is low, or when a systemic biopsy has already been done beforehand. More and more radiologists and urologists focused on the issue of optimization of prostate biopsy schemes. Previous studies found that the majority of csPCa were found within a band of 10-mm radius outside MRI lesions (the penumbra). Based on the penumbra theory, the perilesional/regional systematic biopsy (PB/RSB) has gradually received urologists' attention. Some studies demonstrated that the prostate cancer (PCa) detection rate was not inferior to the combined biopsy with the benefits of using fewer biopsy cores. However, the safety profile warrants further evaluation, and there is still a lack of high-quality, prospective evidence for the PB schemes. Thus, this multicenter randomized controlled trial (RCT) aims to evaluate the efficacy of TB+PB schemes and the routine TB+SB schemes, provide high-quality evidence for the optimization of prostate biopsy schemes.
The main questions it aims to answer are:
Does PB promote the accurate diagnosis of csPCa? What is the value of PB in improving the safety of prostate biopsy? This prospective, multi-institution RCT compared the csPCa detection rates of TB+PB and TB+SB. Participants were prospectively enrolled and were randomly allocated to TB+PB group and TB+SB group.
Researchers will compare the cancer detection rates of TB+PB and TB+SB to explore the efficacy of different prostate biopsy schemes.
Participants will:
Receive TB+PB or TB+SB.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TB+PB group | Experimental | For each predefined MRI suspicious lesion, TB cores were obtained within each predefined MRI suspicious lesion (region of interest, ROI), followed by ring-distributed PB cores within a 10-15 mm radius around the ROI. The location of these cores depended on the shape and location of the suspicious lesion. |
|
| TB+SB group | Experimental | For patients in the TB+SB group, TB cores were obtained from the lesion, followed by 12-core SB. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TB+PB | Procedure | The biopsy procedure was conducted by highly skilled and experienced urologists who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. For each predefined MRI suspicious lesion, TB cores were obtained within each predefined MRI suspicious lesion (region of interest, ROI), followed by ring-distributed PB cores within a 10-15 mm radius around the ROI. The location of these cores depended on the shape and location of the suspicious lesion. |
| Measure | Description | Time Frame |
|---|---|---|
| The clinically significant prostate cancer (csPCa) detection rate for TB+PB and TB+SB | csPCa was defined as PCa with a grade group > 2 or GS ≥ 7. The reference standard was the pathological result. | One month after the biopsy procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| The PCa detection rate | The PCa detection rate for TB+PB and TB+SB. | One month after the biopsy procedure. |
| The high-grade PCa detection rate | The high-grade PCa was defined as PCa with a grade group ≥3 or GS≥4+3. The reference standard was the pathological result. |
| Measure | Description | Time Frame |
|---|---|---|
| The self-reported quality of life after the prostate biopsy | The self-reported levels of pain and discomfort after the prostate biopsy was measured through visual analogue scale (VAS). The minimum and maximum values of VAS are 0 and 10. The higher VAS means the higher level of pain and discomfort. | One month after the biopsy procedure. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yi LIU | Contact | +86 13611035261 | liuyipkuhsc@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yi LIU | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| UNKNOWN |
| Zhejiang Cancer Hospital | OTHER |
| First Affiliated Hospital of Chongqing Medical University | OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
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| TB+SB | Procedure | The biopsy procedure was conducted by highly skilled and experienced urologists who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. TB cores were obtained from the lesion, followed by 12-core SB. |
|
| One month after the biopsy procedure. |
| The clinically insignificant PCa (ciPCa) detection rate | The ciPCa was defined as PCa with a grade group <2 or GS <3+4. The reference standard was the pathological result. | One month after the biopsy procedure. |
| The Gleason score (GS) of the biopsy sample | The Gleason score (GS) was reported by senior uropathologists according to the Standards of Reporting for MRI Targeted Biopsy Studies (START) criteria and interpreted according to the recommendations of the International Society of Urological Pathology (ISUP) Grade Group. The minimum and maximum of GS are 3 and 5. The higher GS means the higher pathological grade. | One month after the biopsy procedure. |
| The Gleason score (GS) of radical prostatectomy (RP) specimens |
For the RP specimens, the Gleason score (GS) was reported by senior uropathologists according to the Standards of Reporting for MRI Targeted Biopsy Studies (START) criteria and interpreted according to the recommendations of the International Society of Urological Pathology (ISUP) Grade Group. The minimum and maximum of GS are 3 and 5. The higher GS means the higher pathological grade. |
| One month after the biopsy procedure. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |