Clinical trial · Observational
Radioactive Counts From PSMA PET/CT-Targeted Biopsy Specimens for Real-time Diagnosis of Prostate Cancer: A Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention (observational study) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- description
- 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.
- interventionNames
- Other: No intervention (observational study)
Primary outcomes (2)
- measure
- Diagnostic performance of core-level CPM
- timeFrame
- Periprocedural
- description
- Diagnostic performance of core-level CPM in differentiating cancer-positive from cancer-negative cores, expressed as area under the curve (AUC)
- measure
- Determination of the optimal CPM cutoff value
- timeFrame
- Periprocedural
- description
- Determination of the optimal CPM cutoff value for intraoperative real-time prediction of cancer-positive cores.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available