Therapeutic Efficiency and Response to 2.0 GBq (55mCi) 177Lu-EB-PSMA in Patients With mCRPC
13 de julio de 2022 actualizado por: Peking Union Medical College Hospital
In recent years, quite a few studies have demonstrated the possibility of 177Lu-PSMA-617 therapy as a viable treatment option in metastatic castration resistant prostate cancer (mCRPC), which has been shown desired effect.
To increase tumor accumulation and retention for radioligand therapy, and reduce dosage of 177Lu, we conjugated a truncated Evans blue (EB) molecule and DOTA chelator onto PSMA-617 (EB-PSMA) and labeled it with 177Lu.
This study is designed to assess the efficiency and response to 177Lu-EB-PSMA (55 mCi) in patients with mCRPC.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
Prostate cancer is one of the most common cancers and the second most frequent cause of cancer deaths for adult men.
With the advances in the diagnosis and treatment of prostate cancer, some patients with localized prostate cancer can achieve good curative results, but there are still 10%～20% of patients progress to metastatic castration-resistant prostate cancer (mCRPC) every year, only one third of patients with mCRPC survive more than five years.
Radioligand therapy targeting prostate specific membrane antigen (PSMA), which is overexpressed in most prostate cancer and even further increased in metastatic and castration-resistant carcinomas, has been demonstrated as an effective and safe therapy in men with mCRPC.
177Lu-PSMA-617 has also shown desired effect.
However, 177Lu-PSMA-617, as a small molecule imaging agent, is cleared very quickly from the circulation.
Therefore, radiotherapy that is based on small molecules requires high doses and frequent administrations, leading to systemic toxicity.
To increase tumor accumulation and retention for radioligand therapy, and reduce dosage of 177Lu, the investigators conjugated a truncated Evans blue (EB) molecule and DOTA chelator onto PSMA-617 (EB-PSMA) and labeled it with 177Lu.
The investigators have published some articles demonstrated 177Lu-EB-PSMA had much higher accumulation in prostate cancer lesions than 177Lu-PSMA-617 and also showed an ideal effect.
This study is designed to assess the efficiency and response to 177Lu-EB-PSMA (55 mCi) in patients with mCRPC.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
30
Fase
- Fase temprana 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100730
- Reclutamiento
- Peking Union Medical College Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 90 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Descripción
Inclusion Criteria:
- All the patients had progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy;
- Distant metastases with high PSMA expression were confirmed on 68Ga-PSMA PET/CT within one week before the injection of 177Lu-EB-PSMA.
Exclusion Criteria:
- The exclusion criteria were a serum creatinine level of more than 150 μmol per liter, a hemoglobin level of less than 10.0 g/dl, a white-cell count of less than 4.0× 109/L, a platelet count of less than 100 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 2.0 GBq of 177Lu-EB-PSMA
The patients were intravenously injected with the dose about 2.0 GBq (55 mCi) of 177Lu-EB-PSMA and underwent 68Ga-PSMA PET/CT scans before and after the treatment.
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Patients were intravenous administrated with the dose about 2.0 GBq (55 mCi) of 177Lu-EB-PSMA every 8 weeks (±1 week) for a maximum of 3 cycles.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Therapeutic effect: PSA Response
Periodo de tiempo: through study completion, an average of 1 month
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The serum PSA response was documented monthly until 8 weeks after the last treatment therapy, which can effectively reflect the treatment effect of prostate cancer.
Biochemical response was classified as the following: partial response (PR) if PSA decrease ≥50%, progressive disease (PD) if PSA increase ≥ 25% and stable disease (SD) if PSA increase <25% or PSA decrease <50%.
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through study completion, an average of 1 month
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Therapeutic effect: 68Ga-PSMA PET/CT Response
Periodo de tiempo: through study completion, an average of 2 months
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68Ga-PSMA-617 wholebody PET/CT acquisitions 8 weeks after each cycle of treatment.
The molecular response was classified according to adapted modified PERSIST 1.0 criteria.
Complete response (CR) was complete resolution of 68Ga-PSMA-617 uptake in the target lesions.
Partial response (PR) was defined as ≥30% decrease in the SUVmax of the target lesions and total Lesions PSMA from the baseline scan, and ≥ 30% increase in the SUVmax value of the target lesions and total Lesions PSMA from the baseline scan was taken as progressive disease (PD).
Neither CR, PR nor PD was considered stable disease (SD) that was <30% decrease or <30% increase of the target lesion.
Changes of SUV (ΔSUV) between pre- and post-therapeutic PET were calculated.
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through study completion, an average of 2 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Adverse events collection: Blood tests
Periodo de tiempo: through study completion, an average of 1 month
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Blood tests including hematologic status, liver function, and renal function were performed before and every two weeks after each cycle of treatment for a period of 8 weeks.
Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
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through study completion, an average of 1 month
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
14 de enero de 2019
Finalización primaria (Anticipado)
1 de septiembre de 2022
Finalización del estudio (Anticipado)
1 de diciembre de 2022
Fechas de registro del estudio
Enviado por primera vez
22 de julio de 2021
Primero enviado que cumplió con los criterios de control de calidad
30 de julio de 2021
Publicado por primera vez (Actual)
9 de agosto de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de julio de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
13 de julio de 2022
Última verificación
1 de julio de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PekingUMCH Lu-EB-PSMA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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