Targeted Biopsy, Rapid Pathology, and Immediate Surgery in USTC High-Risk Prostate Cancer: A Prospective Multicenter Study
A Multicenter, Prospective, Single-Arm Clinical Trial Evaluating MRI/Ultrasound Fusion Targeted Biopsy With Intraoperative Frozen Section and Rapid Immunohistochemistry Followed by Immediate Laparoscopic Radical Prostatectomy in Patients With High-Risk Prostate Cancer Identified by the USTC Model
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Study Design and Setting This is a prospective, multicenter, single-arm, open-label clinical study conducted in 12 tertiary hospitals in China that have established multidisciplinary prostate cancer teams.
Screening and Enrollment Male patients with clinical suspicion of prostate cancer undergo serum total PSA testing and 3.0T multiparametric MRI. Prostatic volume is measured to calculate prostate-specific antigen density (PSAD), and the index lesion is scored using PI-RADS v2.1. These parameters are entered into the USTC online nomogram (https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/) to generate a predicted probability of clinically significant prostate cancer (csPCa). Patients with a predicted probability ≥0.60, who meet all eligibility criteria (PSA 4-100 ng/mL, at least one PI-RADS ≥3 lesion, ECOG 0-1, no contraindication to general anesthesia or radical prostatectomy, and no evidence of metastasis), are fully informed and asked to provide written consent. Enrolled participants proceed directly to the interventional pathway.
Intervention Under general anesthesia, MRI/ultrasound fusion targeted biopsy (2-4 cores from the index lesion) is performed. The cores are immediately submitted for frozen section hematoxylin-eosin staining and rapid immunohistochemistry (key antibodies: P63, P504s, CK5/6). A pathologist provides a report within 30-60 minutes.
If csPCa is diagnosed intraoperatively, the patient is repositioned and laparoscopic radical prostatectomy is completed under the same anesthesia session.
If rapid pathology returns benign tissue, atypical small acinar proliferation, high-grade prostatic intraepithelial neoplasia, or is non-diagnostic, the procedure is stopped; only the biopsy is performed, and further management follows standard care.
Endpoints and Follow-up Primary endpoints: Positive Predictive Value (PPV) of intraoperative frozen section combined with rapid immunohistochemistry for clinically significant prostate cancer (csPCa) Secondary endpoints: ① Positive surgical margin rate; ② Agreement rate between intraoperative rapid pathology and postoperative paraffin-embedded pathology according to the ISUP grading system. ② Biochemical recurrence rates at 3, 6, and 12 months postoperatively (defined as two consecutive postoperative serum PSA levels ≥ 0.2 ng/mL with an interval of at least 3 weeks; cumulative incidence will be calculated). ③ Incidence of perioperative complications. ③ Incidence of serious adverse events (SAEs). ④ Intraoperative blood loss (mL) and perioperative (intraoperative to 30 days postoperatively) transfusion rate. ⑤ Rehospitalization rate within 30 days postoperatively. ⑥ Urinary continence recovery rate at 3, 6, and 12 months postoperatively.
Follow-up visits occur at 30 days, 3, 6, and 12 months post-procedure. All data are captured via paper case report forms and managed centrally
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
① Patients with clinically suspected prostate cancer based on examination (e.g., DRE or PSA testing); ② Patients who have undergone serum tPSA testing and mpMRI; ③ 4 ng/mL ≤ tPSA < 100 ng/mL; ④ Patients with a csPCa risk probability of ≥0.60 as assessed by the clinical prediction model (https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/); ⑤ The patient has no significant contraindications for prostate biopsy or radical prostatectomy.
Exclusion Criteria:
① No complete serum tPSA test or mpMRI scan; ② tPSA < 4 ng/mL or ≥ 100 ng/mL; ③ Based on assessment by a clinical prediction model, the patient's probability of csPCa is < 0.60; ④ Patients with a history of multiple biopsies showing no evidence of clinically significant prostate cancer; ⑤ Patients in poor general health who cannot tolerate a biopsy; ⑥ Patients with severe bleeding disorders or those currently undergoing anticoagulant therapy.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: USTC Model-Guided Targeted Biopsy-Rapid Path-Immediate RP
Participants with USTC model-predicted csPCa probability ≥0.60 undergo general anesthesia and MRI/ultrasound fusion targeted biopsy (2-4 cores).
Fresh cores are processed immediately for frozen HE and rapid IHC (P504s, p63, CK5/6).
If intraoperative diagnosis is csPCa, immediate laparoscopic radical prostatectomy is performed in the same anesthesia.
If pathology is benign, ASAP, HGPIN, or non-diagnostic, only the biopsy is completed and the participant follows standard care.
|
Integrated diagnostic-therapeutic pathway: 1) preoperative risk stratification by USTC nomogram (PSAD + PI-RADS); 2) general anesthesia and MRI/ultrasound fusion targeted biopsy; 3) intraoperative frozen HE and rapid IHC (P504s, p63, CK5/6); 4) if csPCa is diagnosed, immediate laparoscopic radical prostatectomy under the same anesthesia; otherwise, only the biopsy procedure is performed.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Positive Predictive Value (PPV) of intraoperative frozen section combined with rapid immunohistochemistry for clinically significant prostate cancer (csPCa)
Zeitfenster: At the time of final paraffin pathology report (usually within 7-14 days after surgery)
|
PPV is defined as the proportion of participants who are diagnosed with csPCa by intraoperative frozen section and rapid immunohistochemistry and undergo immediate radical prostatectomy, in whom postoperative paraffin-embedded pathology (the gold standard) confirms the presence of csPCa.
The target PPV is set at ≥95%.
|
At the time of final paraffin pathology report (usually within 7-14 days after surgery)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Positive surgical margin rate
Zeitfenster: At the time of final paraffin pathology report (usually within 7-14 days after surgery)
|
The proportion of participants with cancer involvement at the surgical margin on postoperative paraffin pathology.
|
At the time of final paraffin pathology report (usually within 7-14 days after surgery)
|
|
Concordance of ISUP grade between intraoperative rapid pathology and postoperative paraffin pathology Concordance of ISUP grade between intraoperative rapid pathology and postoperative paraffin pathology
Zeitfenster: At the time of final paraffin pathology report (usually within 7-14 days after surgery)
|
Weighted Kappa coefficient for the agreement of ISUP grade groups assessed by intraoperative frozen section plus rapid immunohistochemistry versus postoperative paraffin pathology.
|
At the time of final paraffin pathology report (usually within 7-14 days after surgery)
|
|
Perioperative complication rate
Zeitfenster: Up to 30 days after surgery
|
The proportion of participants experiencing any perioperative complication, graded according to the Clavien-Dindo classification
|
Up to 30 days after surgery
|
|
Rate of serious adverse events (SAEs)
Zeitfenster: From the day of surgery through 12 months of follow-up
|
The proportion of participants experiencing any SAE, defined and graded according to CTCAE version 5.0.
|
From the day of surgery through 12 months of follow-up
|
|
Intraoperative blood loss and perioperative blood transfusion rate
Zeitfenster: Intraoperative and up to 30 days after surgery
|
Volume of intraoperative blood loss (mL) and the proportion of participants receiving any blood transfusion during surgery or within 30 days postoperatively.
|
Intraoperative and up to 30 days after surgery
|
|
30-day readmission rate
Zeitfenster: 30 days after initial discharge
|
The proportion of participants readmitted to the hospital for any cause within 30 days after discharge following the study procedure.
|
30 days after initial discharge
|
|
Urinary continence recovery rate Urinary continence recovery rate Urinary continence recovery rate
Zeitfenster: 3, 6, and 12 months after surgery
|
The proportion of participants achieving urinary continence (defined as 24-hour urine pad weight <10 g) at 3, 6, and 12 months postoperatively.
|
3, 6, and 12 months after surgery
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Urogenitale Erkrankungen
- Genitalerkrankungen
- Pathologische Prozesse
- Genitale Neubildungen, männlich
- Urogenitale Neoplasmen
- Neubildungen nach Standort
- Neubildungen
- Genitalerkrankungen, männlich
- Prostataerkrankungen
- Männliche Urogenitalerkrankungen
- Pathologische Zustände, Anzeichen und Symptome
- Prostataneoplasmen
- Erkrankung
Andere Studien-ID-Nummern
- Frost-RP
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .