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临床试验/NCT06813898
NCT06813898招募中1 期

ENLIGHTEN: Detection by POSLUMA Following Negative Other PET-PSMA Imaging

Northwestern University2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2025年4月11日最近更新:
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
入组人数
27
试验地点
2
主要终点
Consensus detection rate

研究概览

简要总结

This phase II trial evaluates an imaging technique (rhPSMA-7.3 positron emission tomography [PET]/computed tomography [CT]) for detecting prostate cancer in patients who have increasing prostate-specific antigen levels following prior treatment (biochemical recurrence) but who were prostate specific membrane antigen negative on their most recent PET scan. Contrast agents like rhPSMA-7.3 (also called POSLUMA) circulate in the blood until they find their intended target. Once they are taken up by the target tumor cells, they can be visualized using PET/CT cameras. A PET scan is a procedure in which a small amount of radioactive tracer (in this case rhPSMA-7.3) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is taken up. Because tumor cells often take up more tracer than normal cells, the pictures can be used to find tumor cells in the body. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. The researchers want to determine whether the rhPSMA7.3 PET/CT scan is useful for detecting biochemically recurrent prostate cancer in patients who were negative on prior non-POSLUMA PET imaging.

详细描述

PRIMARY OBJECTIVE:

I. Determine consensus detection rate by flotufolastat F-18 gallium (rhPSMA-7.3)-PET (POSLUMA) scan in men with recent negative non-POSLUMA PET prostate specific membrane antigen (PSMA) scans.

SECONDARY OBJECTIVES:

I. Determine patient level verified detection rates (by histopathology or a surrogate standard of truth [second contemporaneous imaging, treatment response/change in subsequent imaging]).

II. Determine change in management plan based on POSLUMA scan (major / minor).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

Reads will be completed by three trained radiologists blinded to each other's reads.

入排标准

性别
Male
接受健康志愿者

入选标准

  • Men with a history of prostate adenocarcinoma treated with local therapy (including radical prostatectomy or radical prostatectomy and secondary therapy [i.e. salvage radiation])
  • Men must have biochemical recurrence (defined as PSA >= 0.1ng/ml) after therapy
  • PSA < 0.5ng/ml (within 90 days of enrollment)
  • Men must have had negative or equivocal PET PSMA based imaging with 90 days of enrollment with an Food and Drug Administration (FDA) approved non-POSLUMA tracer
  • Non-castrate testosterone (testosterone [T] > 50ng/dL) within 90 days of study entry
  • Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures
  • Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study
  • Concurrent diseases and malignancies are permitted

排除标准

  • Most recent PSA not between 0.1ng/ml and 0.5ng/ml
  • Men with non-metastatic castrate resistant prostate cancer (defined as rising PSA and T < 50ng/dl)
  • Patients receiving 5-alpha reductase inhibitors, androgen deprivation therapy and androgen receptor antagonists within 3 months of enrollment (men may start these therapies at physician discretion immediately following POSLUMA PET PSMA scan)

研究组 & 干预措施

Diagnostic (rhPSMA-7.3 PET/CT)

Experimental

Patients receive rhPSMA 7.3 IV and undergo PET/CT 60 minutes later on day 1.

干预措施: Flotufolastat F-18 Gallium (Drug)

Diagnostic (rhPSMA-7.3 PET/CT)

Experimental

Patients receive rhPSMA 7.3 IV and undergo PET/CT 60 minutes later on day 1.

干预措施: Positron Emission Tomography (Procedure)

Diagnostic (rhPSMA-7.3 PET/CT)

Experimental

Patients receive rhPSMA 7.3 IV and undergo PET/CT 60 minutes later on day 1.

干预措施: Computed Tomography (Procedure)

Diagnostic (rhPSMA-7.3 PET/CT)

Experimental

Patients receive rhPSMA 7.3 IV and undergo PET/CT 60 minutes later on day 1.

干预措施: Electronic Health Record Review (Other)

结局指标

主要结局

Consensus detection rate

时间窗: Up to 2 years

Reads will be completed for the positron emission tomography (PET)/computed tomography (CT) by three trained radiologist blinded to each other's read. Uptake values of rhPSMA-7.3 (POSLUMA) in the prostate bed and other sites (i.e. lymph nodes or bones) will be evaluated. Location and avidity (standardized uptake value) of all identified PET positive sites will be recorded (series/slice number). Consensus read will be determined as positive or negative at the patient level as the consensus of at least 2 of the 3 reading radiologists. Detection rates will be presented with 95% confidence intervals.

次要结局

  • Patient level verified detection rates(Up to 2 years)
  • Change in management plan based on POSLUMA scan(Up to 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashley Ross MD, PhD

Principal Investigator

Northwestern University

研究点 (2)

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