NCT07709403

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
11mo left

Started Aug 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 8, 2026

Last Update Submit

July 13, 2026

Conditions

Prostate Cancer

Keywords

Prostate cancer; PSMA PET/CT; Radioactive counts; Targeted biopsy

Outcome Measures

Primary Outcomes (2)

  • 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)

    Periprocedural

  • Determination of the optimal CPM cutoff value

    Determination of the optimal CPM cutoff value for intraoperative real-time prediction of cancer-positive cores.

    Periprocedural

Secondary Outcomes (3)

  • Correlations of CPM with pathological features

    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

    Periprocedural

  • Histopathological characteristics of false-positive and false-negative cores

    Periprocedural

Study Arms (1)

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.

Other: No intervention (observational study)

Interventions

No intervention (observational study)OTHER

No intervention

Group 1

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing prostate biopsy at Peking University First Hospital due to suspected prostate cancer and meeting eligibility criteria

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

The specimens obtained in this study are prostate biopsy core tissues collected via combined targeted and systematic transperineal or transrectal biopsy. Each core is an individual tissue specimen, approximately 1.0-1.5 cm in length and 18-gauge in diameter, obtained from either a PSMA PET/CT-detected suspicious lesion (targeted cores) or standard systematic sampling sites (systematic cores).

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Observation

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Central Study Contacts

Yi Liu, MD

CONTACT

8613611035261liuyipkuhsc@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 8, 2026

First Posted

July 16, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share