Radioactive Counts From PSMA PET/CT-Targeted Biopsy Specimens for Real-time Diagnosis of Prostate… (NCT07709403) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Radioactive Counts From PSMA PET/CT-Targeted Biopsy Specimens for Real-time Diagnosis of Prostate Cancer: A Prospective Study
20 participantsStarted 2026-08-01
Plain-language 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. 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.
Who can participate
Age range
18 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.