Prostate CancerNCT07709403
Radioactive Counts From PSMA PET/CT-Targeted Biopsy Specimens for Real-time Diagnosis of Prostate Cancer: A Prospective Study
An observational study of Prostate Cancer, run by Peking University First Hospital.
Trial summary
This study aims to establish the diagnostic threshold and efficacy of radioactive counts (CPM) from biopsy specimens in distinguishing cancer-containing from non-cancer-containing cores, using prostate biopsy pathology as the gold standard. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Jun 2027
- Phase
- Observational
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing prostate biopsy at Peking University First Hospital due to suspected prostate cancer and meeting eligibility criteria
Who may be able to join
- Age 18-80 years;
- Meeting clinical indications for prostate biopsy (serum PSA persistently >4 ng/mL, and at least one lesion with PI-RADS ≥ 3 on magnetic resonance imaging [MRI]);
- At least one suspicious lesion detected on PSMA PET/CT;
- No prior prostate biopsy
Who cannot join
- Prior chemotherapy, pelvic radiotherapy, or androgen deprivation therapy (ADT) for prostate cancer;
- Prior prostate surgery (transurethral resection of the prostate, etc.);
- Any contraindications to prostate biopsy, such as active urinary tract infection or indwelling urinary catheter;
- Biopsy core data with failed gamma spectrometer measurement due to technical reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study aims to establish the diagnostic threshold and efficacy of radioactive counts (CPM) from biopsy specimens in distinguishing cancer-containing from non-cancer-containing cores, using prostate biopsy pathology as the gold standard. On this basis, we quantitatively analyze the correlations between CPM and both tumor ISUP grade and tumor length, thereby inversely calibrating the pathological significance of PSMA PET/CT imaging signals. Furthermore, we seek to preliminarily define a reference range of imaging signal intensity sufficient to safely obviate the need for biopsy, thereby providing direct pathological evidence to advance non-invasive, biopsy-free diagnosis of prostate cancer.
Read the detailed description
This is a single-center, prospective, observational proof-of-concept study designed to validate the diagnostic value of radioactive counts (CPM) from prostate biopsy cores in intraoperative real-time differentiation between cancer-containing and non-cancer-containing tissue, using histopathology as the gold standard.
All enrolled patients will undergo PSMA PET/CT imaging, followed by prostate biopsy within 3 hours after image acquisition. Biopsy procedures will be performed by a designated urological ultrasonographer using a combined targeted and systematic approach: targeted biopsy (up to 3 cores per suspicious lesion identified on PET/CT) will be performed for each detectable lesion, supplemented by systematic biopsy. The biopsy procedure itself does not deviate from the current standard clinical protocol.
The distinctive procedural addition lies in specimen handling: immediately after each core is obtained, it will be placed into a pre-labeled EP tube. Within 30 minutes following completion of the biopsy procedure, each core will be measured for counts per minute (CPM) using a calibrated gamma spectrometer. All CPM measurements will be recorded independently without knowledge of the corresponding pathological results and will subsequently be compared with final histopathological diagnoses on a core-by-core basis in a blinded manner. To minimize the impact of counting overflow or statistical fluctuation, each core will be measured for a duration of 60 seconds, with the measurement repeated twice and the mean value taken as the final CPM. For cores containing multiple tissue fragments, the total radioactivity of all fragments will be measured without separation.
In the post-processing phase, receiver operating characteristic (ROC) analysis will be used to determine the optimal CPM diagnostic cutoff value. Further quantitative analyses will be performed to evaluate the correlations between CPM values and ISUP grade, tumor length, and immunohistochemical PSMA expression levels. Additionally, this study will preliminarily explore the feasibility of using a CPM threshold as a reference range for safely omitting biopsy, specifically by investigating whether there exists a lower CPM limit below which the probability of clinically significant prostate cancer (csPCa) detected in the corresponding core falls below a pre-specified safety threshold.
The CPM data obtained in this study will be jointly analyzed with patients' baseline clinical information (e.g., PSA levels), multiparametric MRI features (PI-RADS score, ADC value), and PET/CT quantitative parameters (SUVmax, SUVmean), in order to assess whether CPM provides additional diagnostic information independent of existing imaging parameters. All pathological diagnoses will be rendered independently by two experienced uropathologists, with consensus reached through discussion in cases of disagreement.
This study adds only the radioactive measurement procedure to the biopsy cores, without altering the routine clinical diagnostic and treatment pathway or the biopsy protocol, and does not subject patients to additional invasive procedures or radiation exposure beyond standard care. The study has been approved by the Institutional Review Board of Peking University First Hospital, and written informed consent will be obtained from all enrolled participants.
- Conditions
- Prostate Cancer
- Being tested
- No intervention (observational study)
- Keywords
- Prostate cancer; PSMA PET/CT; Radioactive counts; Targeted biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | This study is a prospective observational cohort study enrolling 20 patients with suspected prostate cancer. It does not involve any additional medical intervention beyond the routine biopsy procedure, with the only addition being radioactive counting of biopsy specimens. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of core-level CPM
Diagnostic performance of core-level CPM in differentiating cancer-positive from cancer-negative cores, expressed as area under the curve (AUC)
Measured: Periprocedural
Determination of the optimal CPM cutoff value
Determination of the optimal CPM cutoff value for intraoperative real-time prediction of cancer-positive cores.
Measured: Periprocedural
Secondary outcomes (3)
Correlations of CPM with pathological features
Correlations of CPM with pathological ISUP grade, tumor length, and PSMA expression level detected by immunohistochemistry (IHC).
Measured: Periprocedural
Proportion of cores in which clinically significant prostate cancer (csPCa) is detected on the first or second core and that exhibit high CPM counts
Proportion of cores in which clinically significant prostate cancer (csPCa) is detected on the first or second core and that exhibit high CPM counts
Measured: Periprocedural
Histopathological characteristics of false-positive and false-negative cores
Microscopic pathological features of biopsy cores in which the CPM-based real-time prediction disagrees with the final histopathological diagnosis. For false-positive cores (CPM ≥ cutoff but pathology-negative), we will examine whether the radioactive signal arises from benign histological mimics that express PSMA, such as benign prostatic hyperplasia (BPH), prostatic intraepithelial neoplasia (PIN), inflammation, or stromal components. For false-negative cores (CPM < cutoff but pathology-positive), we will characterize tumor-related histological features that may account for low radioactive uptake, including low tumor grade (ISUP grade 1-2), small tumor foci (microfoci), perineural invasion, or intratumoral heterogeneity in PSMA expression.
Measured: Periprocedural
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 completion31 Jan 2027 (estimated)
- Study completion30 Jun 2027 (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 Peking University First 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LIU Yi, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709403
- Sponsor's protocol ID
- Hotneedle1
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2026
- Last updated
- 16 Jul 2026
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioactive Counts From PSMA PET/CT-Targeted Biopsy Specimens for Real-time Diagnosis of Prostate Cancer: A Prospective Study
- ClinicalTrials.gov ID
- NCT07709403
- Acronym / sponsor ID
- Hotneedle1
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer; PSMA PET/CT; Radioactive counts; Targeted biopsy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (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 study aims to establish the diagnostic threshold and efficacy of radioactive counts (CPM) from biopsy specimens in distinguishing cancer-containing from non-cancer-containing cores, using prostate biopsy pathology as the gold standard. On this basis, we quantitatively analyze the correlations between CPM and both tumor ISUP grade and tumor length, thereby inversely calibrating the pathological significance of PSMA PET/CT imaging signals. Furthermore, we seek to preliminarily define a reference range of imaging signal intensity sufficient to safely obviate the need for biopsy, thereby providing direct pathological evidence to advance non-invasive, biopsy-free diagnosis of prostate cancer.
Detailed description
This is a single-center, prospective, observational proof-of-concept study designed to validate the diagnostic value of radioactive counts (CPM) from prostate biopsy cores in intraoperative real-time differentiation between cancer-containing and non-cancer-containing tissue, using histopathology as the gold standard.
All enrolled patients will undergo PSMA PET/CT imaging, followed by prostate biopsy within 3 hours after image acquisition. Biopsy procedures will be performed by a designated urological ultrasonographer using a combined targeted and systematic approach: targeted biopsy (up to 3 cores per suspicious lesion identified on PET/CT) will be performed for each detectable lesion, supplemented by systematic biopsy. The biopsy procedure itself does not deviate from the current standard clinical protocol.
The distinctive procedural addition lies in specimen handling: immediately after each core is obtained, it will be placed into a pre-labeled EP tube. Within 30 minutes following completion of the biopsy procedure, each core will be measured for counts per minute (CPM) using a calibrated gamma spectrometer. All CPM measurements will be recorded independently without knowledge of the corresponding pathological results and will subsequently be compared with final histopathological diagnoses on a core-by-core basis in a blinded manner. To minimize the impact of counting overflow or statistical fluctuation, each core will be measured for a duration of 60 seconds, with the measurement repeated twice and the mean value taken as the final CPM. For cores containing multiple tissue fragments, the total radioactivity of all fragments will be measured without separation.
In the post-processing phase, receiver operating characteristic (ROC) analysis will be used to determine the optimal CPM diagnostic cutoff value. Further quantitative analyses will be performed to evaluate the correlations between CPM values and ISUP grade, tumor length, and immunohistochemical PSMA expression levels. Additionally, this study will preliminarily explore the feasibility of using a CPM threshold as a reference range for safely omitting biopsy, specifically by investigating whether there exists a lower CPM limit below which the probability of clinically significant prostate cancer (csPCa) detected in the corresponding core falls below a pre-specified safety threshold.
The CPM data obtained in this study will be jointly analyzed with patients' baseline clinical information (e.g., PSA levels), multiparametric MRI features (PI-RADS score, ADC value), and PET/CT quantitative parameters (SUVmax, SUVmean), in order to assess whether CPM provides additional diagnostic information independent of existing imaging parameters. All pathological diagnoses will be rendered independently by two experienced uropathologists, with consensus reached through discussion in cases of disagreement.
This study adds only the radioactive measurement procedure to the biopsy cores, without altering the routine clinical diagnostic and treatment pathway or the biopsy protocol, and does not subject patients to additional invasive procedures or radiation exposure beyond standard care. The study has been approved by the Institutional Review Board of Peking University First Hospital, and written informed consent will be obtained from all enrolled participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No intervention (observational study)This study is a prospective observational cohort study enrolling 20 patients with suspected prostate cancer. It does not involve any additional medical intervention beyond the routine biopsy procedure, with the only addition being radioactive counting of biopsy specimens. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing prostate biopsy at Peking University First Hospital due to suspected prostate cancer and meeting eligibility criteria
Key inclusion criteria (4 listed)
- Age 18-80 years;
- Meeting clinical indications for prostate biopsy (serum PSA persistently >4 ng/mL, and at least one lesion with PI-RADS ≥ 3 on magnetic resonance imaging [MRI]);
- At least one suspicious lesion detected on PSMA PET/CT;
- No prior prostate biopsy
Key exclusion criteria (4 listed)
- Prior chemotherapy, pelvic radiotherapy, or androgen deprivation therapy (ADT) for prostate cancer;
- Prior prostate surgery (transurethral resection of the prostate, etc.);
- Any contraindications to prostate biopsy, such as active urinary tract infection or indwelling urinary catheter;
- Biopsy core data with failed gamma spectrometer measurement due to technical reasons.
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 |
|---|---|---|
| No intervention (observational study)No intervention | Other | Group 1 |
Primary outcome
Diagnostic performance of core-level CPM
Time frame: Periprocedural
Diagnostic performance of core-level CPM in differentiating cancer-positive from cancer-negative cores, expressed as area under the curve (AUC)
Determination of the optimal CPM cutoff value
Time frame: Periprocedural
Determination of the optimal CPM cutoff value for intraoperative real-time prediction of cancer-positive cores.
3 secondary outcomes
Correlations of CPM with pathological features
Time frame: Periprocedural
Proportion of cores in which clinically significant prostate cancer (csPCa) is detected on the first or second core and that exhibit high CPM counts
Time frame: Periprocedural
Histopathological characteristics of false-positive and false-negative cores
Time frame: Periprocedural
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.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Peking University First 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 4 inclusion and 4 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?
Contact Yi Liu, MD (8613611035261, liuyipkuhsc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of core-level CPM (time frame: Periprocedural). The study lists 2 primary outcomes in all. 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.