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临床试验/NCT06335914
NCT06335914
招募中
不适用

Dual PSMA and FDG PET Imaging for Patients With Advanced Prostate Cancer

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 30 人2025年4月3日

概览

阶段
不适用
干预措施
Ga 68 PSMA-11 PET
疾病 / 适应症
Advanced Prostate Cancer
发起方
University Health Network, Toronto
入组人数
30
试验地点
1
主要终点
Proportion of patients with high volume mCSPC having PSMA avid disease
状态
招募中
最后更新
2个月前

概览

简要总结

This study will use Prostate Specific Membrane Antigen (PSMA) and (18)F-Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging in patients with advanced prostate cancer to learn about tumor biology across disease stages and during treatment. This may help with treatment selection and potential response monitoring in the future.

注册库
clinicaltrials.gov
开始日期
2025年4月3日
结束日期
2029年9月4日
最后更新
2个月前
研究类型
Interventional
研究设计
Single Group
性别
Male

研究者

责任方
Sponsor

入排标准

入选标准

  • Male, age ≥ 18 years
  • Histologically or cytologically confirmed prostate cancer (adenocarcinoma)
  • Poor risk patients with mCSPC at study enrollment
  • De novo or recurrent high volume mCSPC as per conventional imaging (CT chest abdomen pelvis, or MRI, plus bone scan) prior to starting ADT and ARPI
  • High or low volume mCSPC plus PSA ≥4.0 after 6-8 months of initiating ADT
  • Willing to undergo study PET scans and remain under the care of medical oncology, radiation oncology or urology physician at Princess Margaret Cancer Center.
  • No prior PSMA or FDG PET imaging within the last 60 days at each specified time point on study
  • Patients enrolled in clinical trials are eligible if they satisfy all other criteria of eligibility

排除标准

  • Under a randomized-controlled trial with unknown allocation of systemic therapy
  • Inability to undergo or successfully complete PSMA PET and FDG PET imaging exams
  • Unable to provide written consent by patient and their legal representatives
  • In the opinion of the treating physician:
  • conditions which would significantly impair the patient's ability to comply with study procedures and follow up
  • Significant uncontrolled comorbidity, which may negatively impact the safety or interpretability of study PET imaging
  • another active malignancy
  • patient on dialysis
  • another radioisotope or investigational systemic agent within 5 half-lives prior to PET imaging

研究组 & 干预措施

PSMA and FDG PET Imaging

Participants advanced prostate cancer will undergo PSMA and FDG PET prior to starting their standard of care treatment and during treatment.

干预措施: Ga 68 PSMA-11 PET

PSMA and FDG PET Imaging

Participants advanced prostate cancer will undergo PSMA and FDG PET prior to starting their standard of care treatment and during treatment.

干预措施: 18F-DCFPyL PET

PSMA and FDG PET Imaging

Participants advanced prostate cancer will undergo PSMA and FDG PET prior to starting their standard of care treatment and during treatment.

干预措施: FDG PET

结局指标

主要结局

Proportion of patients with high volume mCSPC having PSMA avid disease

时间窗: 5 years

次要结局

  • Proportion of patients with PSMA-/FDG+ discordant lesions(5 years)

研究点 (1)

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