Study of the Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Radionuclide Therapy Prior to Radical Prostatectomy in Men With High-risk Localised Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To determine the radiation absorbed dose in the prostate and involved lymph nodes following one or two administrations of Lu-PSMA in men with HRCaP prior to radical prostatectomy
研究概览
简要总结
This clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND)
详细描述
This open label, phase I/II non-randomised clinical trial will evaluate the dosimetry, efficacy and toxicity of Lu-PSMA in men with high PSMA-expressing high-risk localized or locoregional advanced prostate cancer (HRCaP) undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND). Patients will receive one or two cycles of 177Lu-PSMA followed by surgery. The primary objective is to determine the radiation absorbed dose in the prostate and involved lymph nodes. Secondary objectives include evaluating imaging response to therapy using PSMA-PET, biochemical response, pathological response, adverse effects of Lu-PSMA and surgical safety, and health-related Quality of Life (QoL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patient has provided written informed consent.
- •Male patient aged 18 or over at the time of screening
- •Histologically confirmed adenocarcinoma of the prostate, in a patient scheduled for RP and PLND with curative intent
- •High or high-intermediate risk localised or locoregional prostate cancer (HRCaP) by European Association of Urology (EAU) criteria, including any of the following:
- •PSA > 20 ng/mL
- •ISUP grade group 3-5
- •Clinical T-stage by digital rectal examination (DRE) of T2c or higher
- •N1 disease (involvement of lymph nodes at or below the bifurcation of the common iliac arteries)
- •defined radiologically (CT/ MRI, or PSMA PET).
- •High PSMA avidity on 68Ga-PSMA PET/CT, defined as an SUVmax of ≥ 20
- •Normal baseline haematological function; haemoglobin 13.5-17.5g/dl), total white blood cell count (4-11 x 109/l), platelets (150-400 x 109/l), neutrophils (2-7.5 x 109/l) and lymphocytes (1-4 x 109/l)
- •Normal baseline serum biochemistry; sodium 135-145 nmol/l, potassium 3.5-5 nmol/l, chloride 98-108 nmol/l, urea 3-9.2 nmol/l, creatinine 60-120μmol/l
- •Willing and able to comply with all study requirements including all treatments and required assessments including follow up
排除标准
- •Prostate cancer with significant neuroendocrine or other rare variant pathology
- •Prior treatment for prostate cancer including radiotherapy and/or androgen deprivation therapy.
- •Evidence of metastatic disease involving bone, viscera, or lymph nodes superior to the common iliac bifurcation based on CT, MRI, WBBS or PSMA PET/CT.
- •Renal impairment [GFR < 60mL/min].
- •Sjogren's syndrome.
- •A history of or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
研究组 & 干预措施
177Lu-PSMA-617 followed by prostatectomy
177Lu-PSMA-617 followed by prostatectomy
干预措施: 177Lu-PSMA-617 (Drug)
结局指标
主要结局
To determine the radiation absorbed dose in the prostate and involved lymph nodes following one or two administrations of Lu-PSMA in men with HRCaP prior to radical prostatectomy
时间窗: Determined using imaging at 4, 24 and 96 hrs after administration of Lu-PSMA
Establishing the absorbed radiation dose in the prostate and involved lymph nodes (Gy)
次要结局
- To evaluate the imaging response to therapy using PSMA-PET(6 weeks following final administration of Lu-PSMA)
- To evaluate the surgical safety of prostatectomy following Lu-PSMA(Until 8 weeks after prostatectomy)
- To evaluate pathologic response in the prostate following prostatectomy(After prostatectomy, approximately 6 weeks from final Lu-PSMA administration)
- To evaluate toxicity of Lu-PSMA(Until 8 weeks after prostatectomy)
- To evaluate overall health-related Quality of Life (QoL)(baseline, immediately before 2nd cycle Lu-PSMA, immediately before surgery, 8 weeks post surgery, annually up to 3 years)
- To evaluate the biochemical response to therapy(6 weeks following final administration of Lu-PSMA)
- To evaluate prostate cancer health-related Quality of Life (QoL)(baseline, immediately before 2nd cycle Lu-PSMA, immediately before surgery, 8 weeks post surgery, annually up to 3 years)
- To evaluate patient function and bother after prostatectomy(baseline, immediately before 2nd cycle Lu-PSMA, immediately before surgery, 8 weeks post surgery, annually up to 3 years)