Prostate CancerNCT07709338
Targeted Biopsy, Rapid Pathology, and Immediate Surgery in USTC High-Risk Prostate Cancer: A Prospective Multicenter Study
A study testing Targeted Biopsy, Intraoperative Rapid Pathology, and Immediate Radical Prostatectomy (FROST-RP) in people with Prostate Cancer, run by Anhui Provincial Hospital.
Trial summary
This multicenter, prospective, single-arm study evaluates a novel streamlined pathway for men at high risk of clinically significant prostate cancer (csPCa) identified by the USTC model (probability ≥0.60). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Targeted Biopsy, Intraoperative Rapid Pathology, and Immediate Radical Prostatectomy (FROST-RP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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
This multicenter, prospective, single-arm study evaluates a novel streamlined pathway for men at high risk of clinically significant prostate cancer (csPCa) identified by the USTC model (probability ≥0.60). Under general anesthesia, participants undergo MRI/ultrasound fusion targeted biopsy; the cores are immediately analyzed by frozen section hematoxylin-eosin staining and rapid immunohistochemistry. If csPCa is confirmed intraoperatively, laparoscopic radical prostatectomy is performed during the same anesthesia session. The primary aims are to determine the diagnostic concordance between intraoperative rapid pathology and definitive paraffin pathology, the positive surgical margin rate at 12 months, and perioperative safety. The study enrolls 150 participants across 12 Chinese hospitals and is expected to provide evidence supporting an efficient, PET-independent, one-stage diagnostic-therapeutic strategy for clinically significant prostate cancer.
Read the detailed description
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
- Conditions
- Prostate Cancer
- Being tested
- Targeted Biopsy, Intraoperative Rapid Pathology, and Immediate Radical Prostatectomy (FROST-RP)
- Keywords
- Prostate Cancer, Diagnosis, Targeted Biopsy,, Rapid Pathology, Immediate Surgery
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Biopsy, Intraoperative Rapid Pathology, and Immediate Radical Prostatectomy (FROST-RP)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| USTC Model-Guided Targeted Biopsy-Rapid Path-Immediate RP | Experimental | 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. Receives: Procedure: Targeted Biopsy, Intraoperative Rapid Pathology, and Immediate Radical Prostatectomy (FROST-RP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive Predictive Value (PPV) of intraoperative frozen section combined with rapid immunohistochemistry for clinically significant prostate cancer (csPCa)
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%.
Measured: At the time of final paraffin pathology report (usually within 7-14 days after surgery)
Secondary outcomes (7)
Positive surgical margin rate
The proportion of participants with cancer involvement at the surgical margin on postoperative paraffin pathology.
Measured: 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
Weighted Kappa coefficient for the agreement of ISUP grade groups assessed by intraoperative frozen section plus rapid immunohistochemistry versus postoperative paraffin pathology.
Measured: At the time of final paraffin pathology report (usually within 7-14 days after surgery)
Perioperative complication rate
The proportion of participants experiencing any perioperative complication, graded according to the Clavien-Dindo classification
Measured: Up to 30 days after surgery
Rate of serious adverse events (SAEs)
The proportion of participants experiencing any SAE, defined and graded according to CTCAE version 5.0.
Measured: From the day of surgery through 12 months of follow-up
Intraoperative blood loss and perioperative blood transfusion rate
Volume of intraoperative blood loss (mL) and the proportion of participants receiving any blood transfusion during surgery or within 30 days postoperatively.
Measured: Intraoperative and up to 30 days after surgery
30-day readmission rate
The proportion of participants readmitted to the hospital for any cause within 30 days after discharge following the study procedure.
Measured: 30 days after initial discharge
Urinary continence recovery rate Urinary continence recovery rate Urinary continence recovery rate
The proportion of participants achieving urinary continence (defined as 24-hour urine pad weight <10 g) at 3, 6, and 12 months postoperatively.
Measured: 3, 6, and 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tao Tao, MD, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709338
- Sponsor's protocol ID
- Frost-RP
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07709338
- Acronym / sponsor ID
- Frost-RP
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Diagnosis, Targeted Biopsy,, Rapid Pathology, Immediate Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, prospective, single-arm study evaluates a novel streamlined pathway for men at high risk of clinically significant prostate cancer (csPCa) identified by the USTC model (probability ≥0.60). Under general anesthesia, participants undergo MRI/ultrasound fusion targeted biopsy; the cores are immediately analyzed by frozen section hematoxylin-eosin staining and rapid immunohistochemistry. If csPCa is confirmed intraoperatively, laparoscopic radical prostatectomy is performed during the same anesthesia session. The primary aims are to determine the diagnostic concordance between intraoperative rapid pathology and definitive paraffin pathology, the positive surgical margin rate at 12 months, and perioperative safety. The study enrolls 150 participants across 12 Chinese hospitals and is expected to provide evidence supporting an efficient, PET-independent, one-stage diagnostic-therapeutic strategy for clinically significant prostate cancer.
Detailed description
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| USTC Model-Guided Targeted Biopsy-Rapid Path-Immediate RP | Experimental | Procedure: Targeted Biopsy, Intraoperative Rapid Pathology, and Immediate Radical Prostatectomy (FROST-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Biopsy, Intraoperative Rapid Pathology, and Immediate Radical Prostatectomy (FROST-RP)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. | Procedure or surgery | USTC Model-Guided Targeted Biopsy-Rapid Path-Immediate RP |
Primary outcome
Positive Predictive Value (PPV) of intraoperative frozen section combined with rapid immunohistochemistry for clinically significant prostate cancer (csPCa)
Time frame: 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%.
7 secondary outcomes
Positive surgical margin rate
Time frame: 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
Time frame: At the time of final paraffin pathology report (usually within 7-14 days after surgery)
Perioperative complication rate
Time frame: Up to 30 days after surgery
Rate of serious adverse events (SAEs)
Time frame: From the day of surgery through 12 months of follow-up
Intraoperative blood loss and perioperative blood transfusion rate
Time frame: Intraoperative and up to 30 days after surgery
30-day readmission rate
Time frame: 30 days after initial discharge
Urinary continence recovery rate Urinary continence recovery rate Urinary continence recovery rate
Time frame: 3, 6, and 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Biopsy, Intraoperative Rapid Pathology, and Immediate Radical Prostatectomy (FROST-RP) in people with Prostate Cancer, run by Anhui Provincial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive Predictive Value (PPV) of intraoperative frozen section combined with rapid immunohistochemistry for clinically significant prostate cancer (csPCa) (time frame: At the time of final paraffin pathology report (usually within 7-14 days after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.