Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL
Prostate Cancer · Biochemically Recurrent
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 18 años - No especificado
- Sexo admitido
- Masculino
- Voluntarios sanos
- No aceptados
- Participantes
- 350 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
Background:
Prostate cancer is the second leading cause of cancer-related death in American men. The disease recurs in up to 50,000 men each year after their early-stage disease was treated; however, at this stage, imaging scans are often unable to find the disease in the body. In this natural history study, researchers want to find out if a new radiotracer (18F-DCFPyL) injected before positron emission tomography (PET) imaging can help identify sites in the body with cancer.
Objective:
To learn more about how 18F-DCFPyL PET/CT scans detect change over time in men with recurrent prostate cancer.
Eligibility:
Men aged 18 and older with prostate cancer that returned after treatment.
Design:
Participants will be screened with blood tests. They will also have a bone scan and a computed tomography (CT) scans of the chest, abdomen, and pelvis.
Participants will have an initial study visit. They will have a physical exam and blood tests. They will have a PET/CT scan with 18F-DCFPyL. The radiotracer will be injected into a vein; this will take about 20 seconds. The PET/CT scan will be done 1 to 2 hours later. Participants will lie still on a scanner table while a machine captures images of their body. The scan will take 45 minutes.
Participants will return for blood tests every 3 months.
Participants will return for additional scans with 18F-DCFPyL on this schedule:
Once a year if their previous scan was negative for prostate cancer.
Every 6 months if their previous scan was positive for prostate cancer.
Participants may be in the study up to 5 years.
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Leer la descripción completa
Background:
- Prostate cancer is the most common malignancy and the second leading cause of cancer-related deaths in American men.
- About 25,000 to 50,000 men each year develop a rising prostate-specific antigen (PSA) after definitive radiation or surgery for early-stage disease but have negative findings on computed tomography (CT) and Tc99 bone scan (standard imaging in prostate cancer).
- The recent Food and Drug Administration (FDA) approval of 18F-DCFPyL PET imaging provides an opportunity to locate micrometastatic lesions in patients with recurrent disease.
- It is unknown how these lesions (or prostate cancer) evolve over time in men with positive findings on 18F-DCFPyL PET imaging.
Objective:
-To observe participants with biochemically recurrent prostate cancer for 5 years to understand the evolution of 18F-DCFPyL PET lesions in this population.
Eligibility:
- History of primary treatment for prostate cancer (either surgery or radiation).
- PSA \>= 0.50, and testosterone \>100.
- Age \>=18 years.
- No evidence of metastatic soft tissue disease on CT scan (or MRI), or bone lesions on bone scan.
- No androgen deprivation therapy (ADT), no systemic therapy within the 6 months before the study intervention, and no prostatectomy within 1 year before the study intervention. Clinical trial treatments are allowable within the 6 months before study intervention.
Design:
- Eligible participants will have clinical evaluations and imaging studies. Participants with negative findings on initial/following 18F-DCFPyL scan(s) will be invited approximately every year (+/-12 weeks) for follow-up imaging studies (including 18F-DCFPyL PET scans). Participants with positive findings on initial/following 18F-DCFPyL scan(s) will be invited approximately every 6 months (+/-8 weeks) for repeat scans, not to exceed 2 scans per year.
- After the initial evaluation, participants will be invited to NIH approximately every 3 months (+/- 4 weeks) for PSA testing.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
- INCLUSION CRITERIA:
- History of primary treatment for prostate cancer (either surgery or radiation)
- Serum PSA \>= 0.50
- Serum testosterone \>100
- Age \>=18 years
- Men must agree to use highly effective contraception (surgical sterilization) for 7 days after every study agent administration. Note: abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the subject is also acceptable
- The ability of a participant to understand and the willingness to sign a written informed consent document
EXCLUSION CRITERIA:
-Evidence of soft tissue disease on CT scan (or magnetic resonance imaging \[MRI\] as clinically indicated).
NOTE: Lymph nodes \<= 1.5 cm in the shortest dimension are allowed.
- Evidence of bone lesions on Tc99 bone scan
- Prostatectomy within 1 year before the study intervention
- Androgen deprivation therapy (ADT) within the 6 months before the study intervention
- Systemic therapy for prostate cancer within the 6 months before the study intervention. Other investigational agents, excluding those involving standard of care chemotherapy, received within 6 months prior to the study intervention are allowed.
Población del estudio
Primary clinical
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
Cohort 1
Participants with biochemically recurrent prostate cancer
Drug: 18F-DCFpyL
18F-DCFpyL DRUG
Administered to Cohort.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Observation of 18F-DCFPyL lesions in BRPC
Plazo: baseline through 5 years
Initial 18F-DCFPyL imaging, every 6 months (+/- 8 weeks) for participants positive on imaging, and every 12 months (+/- 12 weeks) for participants negative on imaging until 5 years.
Medidas secundarias
Progression on 18F-DCFPyL
Plazo: baseline through 5 years
Initial 18F-DCFPyL imaging, every 6 months (+/- 8 weeks) for participants positive on imaging, and every 12 months (+/- 12 weeks) for participants negative on imaging until 5 years.
Evaluate PSA doubling in association with 18F-DCFPyL changes
Plazo: baseline through 5 years
PSA test every 3 months (+/- 4 weeks) until 5 years.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
National Institutes of Health Clinical CenterBethesda, Maryland, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- National Cancer Institute (NCI)
- Inicio del estudio
- 21 mar 2023 Real
- Finalización primaria
- 31 dic 2026 Estimado
- Finalización del estudio
- 31 dic 2027 Estimado
- Primera publicación
- 20 oct 2022 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Study of Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18F-DCFPyL
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026