NCT07709403Not yet recruiting
Radioactive Counts From PSMA PET/CT-Targeted Biopsy Specimens for Real-time Diagnosis of Prostate Cancer: A Prospective Study
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 8 Jul 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Peking University First Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT07709403
What you commit to
- Study type: Observational
- Planned participants: 20
- From 1 Aug 2026 to the primary completion date, 31 Jan 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior chemotherapy, pelvic radiotherapy, or androgen deprivation therapy (ADT) for prostate cancer;
- Prior prostate surgery (transurethral resection of the prostate, etc.);
Other illness
- Any contraindications to prostate biopsy, such as active urinary tract infection or indwelling urinary catheter;
Other
- Biopsy core data with failed gamma spectrometer measurement due to technical reasons.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.