ACTRN12620001358932尚未招募1 期
Emerging digital prostate specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) guided Lutetium-177-PSMA therapy pre- and post-prostatectomy in newly diagnosed high risk prostate cancer patients: A feasibility study
I-MED Radiology Network0 个研究点目标入组 5 人开始时间: 2020年12月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •Newly diagnosed high-risk prostate-specific membrane antigen (PSMA)-expressing prostate cancer defined as International Society of Urological Pathologists grade of 5 or Gleason score of 9 or 10, and a minimum standard uptake value of 10 on digital Gallium-68 (Ga68)-PSMA positron emission tomography/computed tomography (PET/CT).
- •Patient must be scheduled for a prostatectomy with a Wesley surgeon.
- •Other inclusion criteria is standard for this treatment at our site.
- •Inclusive of:
- •Referrals for LuPSMA therapy are accepted from Medical Oncologists, Radiation Oncologists or Urologists. On referral, each patient is discussed at a multi-disciplinary team meeting to ensure that there is consensus on the appropriateness of LuPSMA therapy.
- •To confirm suitability for treatment, a Ga68-PSMA PET/CT with diagnostic-quality CT demonstrating PSMA-avid disease is required.
- •Laboratory tests are required to demonstrate; (i) baseline serum prostate-specific antigen (PSA) level, (ii) a full blood count showing acceptable haemoglobin (at least 90 g/L), neutrophil (at least 1.5 x 10^9/L) and platelet (at least 75 x 10^9/L) values, (iii) renal function without impairment (estimated glomerular filtration rate (eGFR) at least 40 mL/min), and (iv) liver function without impairment (albumin at least 25 g/L). Laboratory test results are used as a guide only, with exceptions made on a case-by-case basis.
- •A nuclear medicine renal scan with technetium-99 m mercaptoacetyltriglycine (99mTc-MAG3) is required if there is evidence of renal obstruction or impairment on the diagnostic-CT component of the Ga68-PSMA PET/CT or eGFR test.
排除标准
- •Any disease outside the prostate on digital PSMA PET/CT.
研究者
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