Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL

Официальное название

A Study of Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18F-DCFPyL

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 18F-DCFpyL
  Administered to Cohort.

Первичные конечные точки

• Observation of 18F-DCFPyL lesions in BRPC [Срок оценки: baseline through 5 years]

Вторичные конечные точки (2)

• Progression on 18F-DCFPyL [Срок оценки: baseline through 5 years]
• Evaluate PSA doubling in association with 18F-DCFPyL changes [Срок оценки: baseline through 5 years]

Критерии участия

• 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

Критерии исключения

-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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• National Institutes of Health Clinical Center — Bethesda

Идентификаторы

NCT: NCT05588128 · 10000628 · 000628-C

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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