Evidence map›Paper›PMID 39420060›Full record

Trial reportScientific reports2024

Phase 2 trial of PSMA PET CT versus planar bone scan and CT in prostate cancer patients progressing while on androgen deprivation therapy.

John Nikitas, Andrei Gafita, Matthias R Benz, Loïc Djaïleb, Andrea Farolfi, Masatoshi Hotta, Ida Sonni, Rejah Alano, Matthew Rettig, John Shen and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Scientific reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04928820 (Head-to-Head Comparison of 68Ga-PSMA-11 PET/CT With 99mTc-MDP Bone Scan and CT for Detection of M1b Disease in Prostate Cancer Patients With Biochemical Progression During ADT), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT04928820 phase2terminatednot on this map

Head-to-Head Comparison of 68Ga-PSMA-11 PET/CT With 99mTc-MDP Bone Scan and CT for Detection of M1b Disease in Prostate Cancer Patients With Biochemical Progression During ADT

TypeinterventionalSponsorJonsson Comprehensive Cancer CenterRan2021 to 2022Enrolled22ConditionsBiochemically Recurrent Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Prostate Carcinoma, Stage IV Prostate Cancer American Joint Committee on Cancer (AJCC) v8ArmsComputed Tomography, Gallium Ga 68 Gozetotide, Positron Emission Tomography
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Imaging the hallmarks of cancer.Nature reviews. Cancer · 2026
    Review
  2. Review
  3. Dual targeting PET tracer [Theranostics · 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

15 authors.

John NikitasDepartment of Radiation Oncology, University of California, Los Angeles, CA, USA.
Andrei GafitaDivision of Nuclear Medicine and Molecular Imaging, Department of Radiology and Radiological Science, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Matthias R BenzAhmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California, Los Angeles, CA, USA.
Loïc DjaïlebAhmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California, Los Angeles, CA, USA.
Andrea FarolfiNuclear Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
Masatoshi HottaAhmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California, Los Angeles, CA, USA.
Ida SonniAhmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California, Los Angeles, CA, USA.
Rejah AlanoAhmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California, Los Angeles, CA, USA.
Matthew RettigDepartments of Medicine and Urology, University of California, Los Angeles, CA, USA.
John ShenDepartments of Medicine and Urology, University of California, Los Angeles, CA, USA.
Wesley ArmstrongAhmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California, Los Angeles, CA, USA.
Tristan GroganDepartment of Medicine Statistics Core, University of California, Los Angeles, CA, USA.
Sandy LiuDepartment of Medical Oncology & Therapeutics Research, City of Hope, Los Angeles, CA, USA.
Johannes CzerninAhmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California, Los Angeles, CA, USA.
Jeremie CalaisAhmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology, University of California, Los Angeles, CA, USA. JCalais@mednet.ucla.edu.

Funding

UCLA-Caltech Medical Scientist Training ProgramT32GM008042 · NIGMS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI AJIJOLA, OLUJIMI A, DAWSON, DAVID WAYNE · 1985 to 2023
$29.9M
UCLA SPORE in Brain CancerP50CA211015 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Yvonne Yu-Hsuan Chen · 2017 to 2026
$25.2M
NCI NIH HHS P50 CA211015NIGMS NIH HHS T32 GM008042
6 · The paper itself

Abstract

For prostate cancer patients who experience biochemical progression during androgen deprivation therapy (ADT), prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) has not been prospectively compared to planar bone scan plus CT. This was a single-arm, head-to-head, prospective phase II trial (NCT04928820) designed to enroll 102 men with prostate cancer who experienced biochemical progression (rising prostate-specific antigen [PSA] ≥ 1 ng/mL) during ADT. All patients received 68Ga-PSMA-11 PET/CT and 99mTc-MDP planar bone scans. Each scan was interpreted by three central independent readers. The primary endpoint was the per-patient bone metastasis detection rate of PSMA PET/CT versus planar bone scan and CT. Secondary endpoints compared the number of bone metastases detected per patient and the inter-reader agreement of each imaging modality. Twenty-two men were enrolled between July 2021 and June 2022. Due to slow accrual following approval of PSMA PET radiotracers in the U.S. and a lack of a statistical signal between the two imaging modalities on interim analysis, this trial was closed early on October 2022. Median PSA was 8.5 ng/mL (interquartile range: 1.6-77.6). There was 100% agreement between the two scans. Six patients (27%) had negative findings and 16 patients (73%) had positive findings on both scans. PSMA PET/CT and bone scan plus CT detected an equal number of bone lesions for 14 patients (64%), PSMA PET/CT detected more bone lesions for six patients (27%), and bone scan plus CT detected more bone lesions for two patients (9.1%) (p = 0.092). The inter-reader agreement rates of PSMA PET/CT and bone scan plus CT were 96% and 82%, respectively (p = 0.25). In men with biochemical progression during ADT, 68Ga-PSMA-11 PET/CT and 99mTc-MDP planar bone scan plus CT had identical bone metastasis detection rates. Bone scan plus CT can continue to serve as a cost-effective and readily accessible restaging modality in patients with biochemical progression. ClinicalTrials.gov NCT04928820. Registered 16/06/2021.

Indexed as

Androgen AntagonistsBone NeoplasmsPositron Emission Tomography Computed TomographyProstatic NeoplasmsAgedAged, 80 and overAntigens, SurfaceBone and BonesDisease ProgressionGallium IsotopesGallium RadioisotopesGlutamate Carboxypeptidase IIHumansMaleMiddle AgedProspective StudiesAndrogen AntagonistsAntigens, SurfaceFOLH1 protein, humangallium 68 PSMA-11Gallium IsotopesGallium RadioisotopesGlutamate Carboxypeptidase IIProstate-Specific AntigenRadiopharmaceuticalsAndrogen deprivation therapyBiochemical recurrenceBone metastasesBone scanProstate-specific membrane antigen PET/CT

Identifiers

PMID39420060
PMCPMC11487247

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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.