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ArticleEuropean journal of nuclear medicine and molecular imaging2025

Which patients with negative PSMA-PET imaging can safely avoid biopsy for prostate cancer? a novel step towards PSMA-based biopsy-free strategy.

Yujia Li, Jinhui Yang, Ling Xiao, Ming Zhou, Jian Li, Yi Cai, Xiaomei Gao, Axel Rominger, Kuangyu Shi, Robert Seifert and 3 more

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in European journal of nuclear medicine and molecular imaging, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05073653 (A Study of 68Ga-GRP PET/CT for Imaging in Low and Intermediate Risk Prostate Cancer), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05073653 naunknown statusnot on this map

A Study of 68Ga-GRP PET/CT for Imaging in Low and Intermediate Risk Prostate Cancer

TypeinterventionalSponsorXiangya Hospital of Central South UniversityRan2021 to 2022Enrolled80ConditionsProstate CancerArms68Ga-PSMA PET/CT, 68Ga-GRP PET/CT
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. An Innovative Approach with [Diagnostics (Basel, Switzerland) · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Yujia Li *Department of Nuclear Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Jinhui Yang *Department of Nuclear Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Ling XiaoDepartment of Nuclear Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Ming ZhouDepartment of Nuclear Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Jian LiDepartment of Nuclear Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Yi CaiDepartment of Urology, Disorders of Prostate Cancer Multidisciplinary Team, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Xiaomei GaoDepartment of Pathology, Xiangya Hospital, Central South University, Changsha, Hunan, China.
Axel RomingerDepartment of Nuclear Medicine, Inselspital, University Hospital Bern, Bern, Switzerland.
Kuangyu ShiDepartment of Nuclear Medicine, Inselspital, University Hospital Bern, Bern, Switzerland.
Robert SeifertDepartment of Nuclear Medicine, Inselspital, University Hospital Bern, Bern, Switzerland.
Qi SuPET/CT Center of the First Hospital of Hunan University of Chinese Medicine, Changsha, Hunan, China. 347624205@qq.com.
Yongxiang TangDepartment of Nuclear Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China. 405035@csu.edu.cn.
Shuo HuDepartment of Nuclear Medicine, Xiangya Hospital, Central South University, Changsha, Hunan, China. hushuo2018@163.com.ORCID 0000-0003-0998-8943

Funding

National Natural Science Foundation of China 81801740National Natural Science Foundation of China 82272045Natural Science Foundation of Hunan Province 2022JJ20096Scientific Research Project of Hunan Provincial Health Commision C202309048470
6 · The paper itself

Abstract

purposeThis study aimed to identify if a subset of men can safely avoid or delay prostate biopsy based on negative results of prostate-specific membrane antigen positron emission tomography (PSMA-PET). MATERIALS AND

methodsAmong 341 consecutive cases in a prospective biopsy cohort (NCT05073653), 111 treatment-naïve men with negative PSMA-PET (PRIMARY-score 1/2) were included. All participants underwent PSMA-PET and histopathological examinations. Clinically significant prostate cancer (csPCa) was defined as Grade Group ≥ 2. Multivariate logistic regression was employed to identify predictors of non-csPCa. Receiver operating characteristic (ROC) analysis was performed to detect non-csPCa on prostate pathology. PSMA-postive patients were additionally reviewed to assess the imaging and pathological outcomes.

resultsYounger age was identified as an independent predictor (P = 0.006) for the absence of csPCa. ROC analysis of csPCa revealed the largest areas under the curve of 0.77 (0.67-0.87) and 0.78 (0.68-0.88) for individual age in the entire PSMA-negative cohort and the MRI subset, respectively (both P < 0.001). The negative predictive value (NPV) of PSMA-PET for csPCa detection improved with a decreasing age, from 88% in all, to 98% in men aged under 65 yrs (98% vs. 88%, P = 0.021), and to 100% in men aged under 60 yrs (100% vs. 88%, P = 0.040). The NPV of PSMA-PET improved from 88 to 94% when combined with negative MRI, and to 100% in men with negative MRI and aged under 65 yrs. The prevalence was 57% for csPCa and 65% for PCa of any grade.

conclusionWe preliminarily propose that omission or postponement of prostate biopsy should be considered for men under the age of 65 yrs with negative PSMA-PET scored as PRIMARY 1 or 2. Conversely, prostate biopsy might be considered in biopsy-naïve men aged 65 yrs or older with strong clinical suspicion of PCa, despite negative PSMA-PET. Further prospective and external evaluation is needed to prove the robustness of this novel strategy.

Indexed as

Antigens, SurfaceGlutamate Carboxypeptidase IIPositron-Emission TomographyProstatic NeoplasmsAgedBiopsyHumansMaleMiddle AgedAntigens, SurfaceFOLH1 protein, humanGlutamate Carboxypeptidase IIPositron emission tomographyPredictive value of testsPRIMARY-scoreProstatic neoplasmsPSMA

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.