A Phase III, Open-Label, Multi-center Clinical Study to Assess the Diagnostic Performance and Safety of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate Cancer

In this study, 18F-Florastamin PET/CT will be performed in patients with at least intermediate risk prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET/CT imaging.
This study will first carry out the pilot study (including pharmacokinetics and radiation dosimetry).

Start Date20 Oct 2023

Sponsor / Collaborator

HTA Co., Ltd.

KCT0009634 / RecruitingNot ApplicableIIT

The Clinical Efficacy of [F-18]Florastamin PET/CT for Initial Staging and Relapsed Restaging in Prostate Cancer: A Single-Center Prospective Pilot Study

Start Date16 Oct 2023

Sponsor / Collaborator-

CTR20233678 / RecruitingPhase 3

一项评价氟[18F]司他明注射液PET/CT成像在至少中危前列腺癌患者中的诊断效能及安全性的开放性、多中心III期临床研究

[Translation] An open-label, multicenter phase III clinical study to evaluate the diagnostic efficacy and safety of 18F-fluoro[18F]sitamin injection PET/CT imaging in patients with at least intermediate-risk prostate cancer

在受试者水平，评估氟[18F]司他明注射液PET/CT成像检测盆腔淋巴结转移的特异度。

[Translation]

To evaluate the specificity of 18F-fluoro[18F]setamin injection PET/CT imaging for detecting pelvic lymph node metastasis at the subject level.

Start Date13 Sep 2023

Sponsor / Collaborator

HTA Co., Ltd.

100 Clinical Results associated with [F-18]Florastamin

100 Translational Medicine associated with [F-18]Florastamin

100 Patents (Medical) associated with [F-18]Florastamin

Literatures (Medical) associated with [F-18]Florastamin

01 Jan 1997·Clinical and Experimental MetastasisQ3 · MEDICINE

A new pseudo-peptide of Arg-Gly-Asp (RGD) with inhibitory effect on tumor metastasis and enzymatic degradation of extracellular matrix.

Q3 · MEDICINE

Article

Author: Hideki Fujii ; Ikuo Saiki ; Ichiro Azuma ; Masayoshi Kojima ; Makoto Suzuki ; Hiroyuki Komazawa ; Koichi Ayukawa ; Aya Obata ; Naoyuki Nishikawa ; Isamu Itoh

A series of pseudo-peptide analogs of the Arg-Gly-Asp (RGD) sequence of fibronectin have been synthesized, and their anti-metastatic effects in mice and inhibitory effects on tumor cell invasion in vitro have been examined. The partially modified retro pseudo-peptide of RGD, Rrev-COCH2CO-D (FC-63), was more effective in inhibiting tumor metastasis than the original RGDS peptide. Replacement of the malonyl moiety of FC-63 with a carboxyethylene linkage (Rrev-COCH2CH2-D, FC-303 ) achieved more potent inhibition of lung metastasis of melanoma cells than FC-63. Among the analogs, FC-336, a p-xylylendiamine derivative having two FC-303 moieties, showed the most potent inhibitory effect on experimental lung metastasis produced by i.v. co-injection with B16-BL6 melanoma or colon 26 M3.1 cells in a dose-dependent manner. Multiple administrations of FC-336 after tumor inoculation also showed efficient therapeutic potency against spontaneous lung metastasis of B16-BL6 melanoma in mice. Furthermore, FC-336 effectively inhibited the invasion, migration and adhesion of tumor cells in vitro, but its inhibitory effects were not more than those of RGDS peptide. Zymography analysis revealed that FC-336 inhibited the degradation of gelatin substrate by matrix metalloproteinases (MMPs) produced by tumor cells, while the RGDS peptide did not affect the enzymatic degradation. These findings indicate that the pseudo-peptides of the RGD sequence, possessing the inhibitory property of the degradation by MMPs differently from original RGD-containing peptides, may be advantageous and useful in preventing tumor metastasis.

100 Deals associated with [F-18]Florastamin

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
PSMA-Positive Prostatic Cancer	Phase 3	CN	HTA Co., Ltd.	13 Sep 2023
Metastatic Prostate Carcinoma	Phase 3	KR	FutureChem Co., Ltd.	08 May 2023

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AUA2022	Not Applicable	Prostatic Cancer	82	[F-18]FLORASTAMINR ([F-18] FlorastaminR PET/CT)	lizrfspumw(wrwmbjdswp) = ftqrwguhgz xdggdpoolv (cprgtyqtvh ) View more	-	01 May 2022
				[F-18]FLORASTAMINR (Multi-parametric magnetic resonance imaging (mpMRI))	lizrfspumw(wrwmbjdswp) = makcdmtxaa xdggdpoolv (cprgtyqtvh ) View more

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