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68Ga-PSMA-11

68Ga-PSMA-11 Efficacy in Detecting BCR Prostate Cancer in Chinese Patients

Ensayo de Telix Pharmaceuticals Ltd en Biochemical Recurrence of Malignant Neoplasm of Prostate · Prostate Cancer · BCR Prostate Carcinoma (del registro, en inglés).

Más ensayos de: Cáncer de próstata.

Fase

Fase 3

Estado

Sin noticias del promotor

Participantes

110

previstos

Centros

8

Fin del objetivo primario

dic 2025

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en jul 2023.

Qué mide

Positive Predictive Value (PPV) of 68Ga-PSMA-11 PET/CT or PET/MRI for detection of tumour on a patient level confirmed by histopathology/biopsy, clinical (PSA) and conventional imaging follow-up. (del registro, en inglés) (12 meses)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis is a prospective, open-label, single-arm, multicenter bridging study in Chinese patients with prostate cancer. This multicenter study is planned to be conducted in patients with biochemical recurrence (BCR) of elevated PSA after radical prostatectomy or radical radiotherapy. This study investigates how well 68Ga-PSMA-11 PET/CT works in detecting BCR prostate cancer in Chinese patient. 68Ga-PSMA-11, developed by Telix, is a new molecular entity tracer with the trade name Illuccix®, which is approved by FDA for the examination of: 1) patients with suspected metastatic PC who are scheduled for initial treatment; 2) patients with biochemical recurrence of elevated PSA levels after initial radical radiotherapy.

Más ensayos de TLX

Todos los de TLX, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05847348), actualizada en jun 2024.