Phase 2 trial of PSMA PET CT versus planar bone scan and CT in prostate cancer patients progressing while on androgen deprivation therapy.
Humans
Male
Prostatic Neoplasms
/ diagnostic imaging
Positron Emission Tomography Computed Tomography
/ methods
Aged
Androgen Antagonists
/ therapeutic use
Bone Neoplasms
/ secondary
Middle Aged
Prospective Studies
Prostate-Specific Antigen
/ blood
Disease Progression
Glutamate Carboxypeptidase II
/ metabolism
Antigens, Surface
/ metabolism
Tomography, X-Ray Computed
/ methods
Aged, 80 and over
Bone and Bones
/ diagnostic imaging
Gallium Radioisotopes
Radiopharmaceuticals
Gallium Isotopes
Androgen deprivation therapy
Biochemical recurrence
Bone metastases
Bone scan
Prostate-specific membrane antigen PET/CT
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
18 Oct 2024
18 Oct 2024
Historique:
received:
12
07
2024
accepted:
07
10
2024
medline:
18
10
2024
pubmed:
18
10
2024
entrez:
17
10
2024
Statut:
epublish
Résumé
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.
Identifiants
pubmed: 39420060
doi: 10.1038/s41598-024-75589-6
pii: 10.1038/s41598-024-75589-6
doi:
Substances chimiques
Androgen Antagonists
0
FOLH1 protein, human
EC 3.4.17.21
Prostate-Specific Antigen
EC 3.4.21.77
Glutamate Carboxypeptidase II
EC 3.4.17.21
Antigens, Surface
0
gallium 68 PSMA-11
0
Gallium Radioisotopes
0
Radiopharmaceuticals
0
Gallium Isotopes
0
Banques de données
ClinicalTrials.gov
['NCT04928820']
Types de publication
Journal Article
Clinical Trial, Phase II
Comparative Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
24411Informations de copyright
© 2024. The Author(s).
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