Prostate CancerNCT06677775
Pathological Positivity Rate in Prostate Cancer Patients with PI-RADS 4 and First Negative Biopsy
An observational study of Prostate Cancer, run by Anhui Provincial Hospital at 1 site in China.
Trial summary
The purpose of this prospective, single-center, single-arm trial was to evaluate the pathologic type of re-treatment based on a clear PI-RADS score of ≥4 with a first negative prostate biopsy, belonging to the high-risk group of the USTC diagnostic model, and PSMA PET/CT positive patients, and to evaluate the… Read more about this study
- Who is it for?
- Ages Up to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2024to 30 Aug 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 75 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: * PI-RADS≥4 scores and the first prostate biopsy was negative * USTC clinical diagnosis model calculated risk probability value ≥0.6 * Reexamination of PSMA/PET-CT after the first puncture indicated positive prostatic lesions
Who may be able to join
- PI-RADS≥4 scores and the first prostate biopsy was negative
- USTC clinical diagnosis model calculated risk probability value ≥0.6
- Reexamination of PSMA/PET-CT after the first puncture indicated positive prostatic lesions
Who cannot join
- Life expectancy is less than 15 years
- Multiple metastasis of tumor is possible
- There are serious cardiovascular and cerebrovascular diseases, bleeding tendencies and other surgical or puncture contraindications
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of USTC
Hefei, Anhui, 230001
Tao Tao, 18856069828, taotao_urology@ustc.edu.cn
Tao Tao, MD Ph.D
About this study
Official title: A Prospective Clinical Study Based on USTC Diagnostic Model and PSMA/PET-CT for Direct Radical Prostatectomy in Some Patients with First Negative Biopsy
The purpose of this prospective, single-center, single-arm trial was to evaluate the pathologic type of re-treatment based on a clear PI-RADS score of ≥4 with a first negative prostate biopsy, belonging to the high-risk group of the USTC diagnostic model, and PSMA PET/CT positive patients, and to evaluate the diagnostic efficacy of the USTC diagnostic model combined with PSMA PET/CT. At the same time, to explore whether these patients can directly undergo radical prostatectomy without repeated puncture.
Firstly, patients with PI-RADS≥4 scores were screened and the first prostate biopsy was negative. Then USTC diagnostic model was used to evaluate the risk probability of patients suffering from csPCa to determine whether the patients belonged to the high-risk group. Then PSMA/PET-CT was improved for patients in high-risk group to identify the positive lesions of prostate. Finally, for patients with ≥4 PI-RADS and negative prostate aspiration for the first time, Laparoscopic radical prostatectomy (LRP) was performed compared with high-risk groups of USTC diagnostic model and positive PSMA PET/CT. Transperineal targeted prostate biopsy was performed if intraoperative freeze pathology indicated prostate cancer, then LRP was performed; intraoperative freeze pathology indicated benign prostate biopsy, then transperineal prostate biopsy was performed.
Read the detailed description
Research design This is a prospective, single-center, single-arm, open-label clinical study conducted at the First Affiliated Hospital of the University of Science and Technology of China. Patients with no contraindications to surgery and who meet enrollment criteria will be included in the study. Subsequently, the investigators will recommend that these patients be treated again for PI-RADS≥4, first negative prostate puncture, high-risk group of USTC diagnostic model, and PSMA PET/CT positive patients. Laparoscopic radical prostatectomy (LRP) was directly performed. Transperineal targeted prostate biopsy was performed if intraoperative freeze pathology indicated prostate cancer, then LRP was performed; intraoperative freeze pathology indicated benign prostate biopsy, then transperineal prostate biopsy was performed.
The diagnostic efficacy of USTC diagnostic model combined with PSMA PET/CT was evaluated according to the pathological results of LRP postoperative specimens or prostate biopsy specimens, and whether such patients can directly undergo radical prostatectomy without repeated puncture was also discussed. Before surgery, patients and their families should be fully informed of the surgical risks, the necessity of pathologic confirmation of prostate biopsy, the possibility of benign prostate lesions, and other alternative treatments, including active monitoring, radiotherapy, and focal therapy.
Screening and registration This study consisted of a prostate cancer diagnostic model and a tandem examination of 18F-Prostate-specific membrane antigen 1007 positron emission tomography/computed tomography (18F-PSMA-1007 PET/CT).
For patients with PI-RADS≥4 and negative prostate puncture for the first time, the prostate magnetic resonance score was re-evaluated three months later. For patients with PI-RADS still ≥4, the serum prostate-specific antigen (PSA) test and multi-parameter magnetic resonance imaging (mpMRI) were completed. Prostate-specific antigen density (PSAD) and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS v2.1) score information were obtained. Then through online diagnosis chart (website: https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/) patients with clinically significant probability of the risk of prostate cancer (csPCa). When the csPCa prediction probability is equal to or greater than 0.60, 18F-PSMA-1007 PET/CT is used for further diagnosis. If a patient is still considered to have csPCa after an 18F-PSMA-1007 PET/CT examination, the investigators define this as a positive result. These patients met our study criteria. Notably, patients with a predicted probability of less than 0.60 will no longer receive 18F-PSMA-1007 PET/CT, and patients with a risk probability equal to or greater than 0.60 but negative 18F-PSMA-1007 PET/CT will not meet the inclusion criteria.
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, prostate biopsy, diagnostic model, mpMRI, prostate specific antigen, PI-ARDS
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Reexamination pathologic positive rate of target patients
Measured: 2024-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start30 Aug 2024
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tao Tao, MD, Anhui Provincial Hospital
- Investigators
- Tao Tao, MD Ph.D, Study chair, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677775
- Sponsor's protocol ID
- SNOTOB-III
- Status last verified
- Aug 2024
- First submitted
- 3 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study Based on USTC Diagnostic Model and PSMA/PET-CT for Direct Radical Prostatectomy in Some Patients with First Negative Biopsy
- ClinicalTrials.gov ID
- NCT06677775
- Acronym / sponsor ID
- SNOTOB-III
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, prostate biopsy, diagnostic model, mpMRI, prostate specific antigen, PI-ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 7 Nov 2024 (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.
The purpose of this prospective, single-center, single-arm trial was to evaluate the pathologic type of re-treatment based on a clear PI-RADS score of ≥4 with a first negative prostate biopsy, belonging to the high-risk group of the USTC diagnostic model, and PSMA PET/CT positive patients, and to evaluate the diagnostic efficacy of the USTC diagnostic model combined with PSMA PET/CT. At the same time, to explore whether these patients can directly undergo radical prostatectomy without repeated puncture.
Firstly, patients with PI-RADS≥4 scores were screened and the first prostate biopsy was negative. Then USTC diagnostic model was used to evaluate the risk probability of patients suffering from csPCa to determine whether the patients belonged to the high-risk group. Then PSMA/PET-CT was improved for patients in high-risk group to identify the positive lesions of prostate. Finally, for patients with ≥4 PI-RADS and negative prostate aspiration for the first time, Laparoscopic radical prostatectomy (LRP) was performed compared with high-risk groups of USTC diagnostic model and positive PSMA PET/CT. Transperineal targeted prostate biopsy was performed if intraoperative freeze pathology indicated prostate cancer, then LRP was performed; intraoperative freeze pathology indicated benign prostate biopsy, then transperineal prostate biopsy was performed.
Detailed description
Research design This is a prospective, single-center, single-arm, open-label clinical study conducted at the First Affiliated Hospital of the University of Science and Technology of China. Patients with no contraindications to surgery and who meet enrollment criteria will be included in the study. Subsequently, the investigators will recommend that these patients be treated again for PI-RADS≥4, first negative prostate puncture, high-risk group of USTC diagnostic model, and PSMA PET/CT positive patients. Laparoscopic radical prostatectomy (LRP) was directly performed. Transperineal targeted prostate biopsy was performed if intraoperative freeze pathology indicated prostate cancer, then LRP was performed; intraoperative freeze pathology indicated benign prostate biopsy, then transperineal prostate biopsy was performed.
The diagnostic efficacy of USTC diagnostic model combined with PSMA PET/CT was evaluated according to the pathological results of LRP postoperative specimens or prostate biopsy specimens, and whether such patients can directly undergo radical prostatectomy without repeated puncture was also discussed. Before surgery, patients and their families should be fully informed of the surgical risks, the necessity of pathologic confirmation of prostate biopsy, the possibility of benign prostate lesions, and other alternative treatments, including active monitoring, radiotherapy, and focal therapy.
Screening and registration This study consisted of a prostate cancer diagnostic model and a tandem examination of 18F-Prostate-specific membrane antigen 1007 positron emission tomography/computed tomography (18F-PSMA-1007 PET/CT).
For patients with PI-RADS≥4 and negative prostate puncture for the first time, the prostate magnetic resonance score was re-evaluated three months later. For patients with PI-RADS still ≥4, the serum prostate-specific antigen (PSA) test and multi-parameter magnetic resonance imaging (mpMRI) were completed. Prostate-specific antigen density (PSAD) and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS v2.1) score information were obtained. Then through online diagnosis chart (website: https://ustcprostatecancerprediction.shinyapps.io/dynnomapp/) patients with clinically significant probability of the risk of prostate cancer (csPCa). When the csPCa prediction probability is equal to or greater than 0.60, 18F-PSMA-1007 PET/CT is used for further diagnosis. If a patient is still considered to have csPCa after an 18F-PSMA-1007 PET/CT examination, the investigators define this as a positive result. These patients met our study criteria. Notably, patients with a predicted probability of less than 0.60 will no longer receive 18F-PSMA-1007 PET/CT, and patients with a risk probability equal to or greater than 0.60 but negative 18F-PSMA-1007 PET/CT will not meet the inclusion criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- Up to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- * PI-RADS≥4 scores and the first prostate biopsy was negative * USTC clinical diagnosis model calculated risk probability value ≥0.6 * Reexamination of PSMA/PET-CT after the first puncture indicated positive prostatic lesions
Key inclusion criteria (3 listed)
- PI-RADS≥4 scores and the first prostate biopsy was negative
- USTC clinical diagnosis model calculated risk probability value ≥0.6
- Reexamination of PSMA/PET-CT after the first puncture indicated positive prostatic lesions
Key exclusion criteria (3 listed)
- Life expectancy is less than 15 years
- Multiple metastasis of tumor is possible
- There are serious cardiovascular and cerebrovascular diseases, bleeding tendencies and other surgical or puncture contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reexamination pathologic positive rate of target patients
Time frame: 2024-2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tao Tao, MD Ph.D study chair
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Anhui Provincial Hospital at 1 site in China.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Tao, MD Ph.D (18856069828, taotao_urology@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reexamination pathologic positive rate of target patients (time frame: 2024-2025). 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 7 Nov 2024.