2025-520868-17-00招募中3 期
Use of 64CuCl2 PET/CT Imaging in the selection of patients with prostate cancer in biochemical relapse after prostatectomy, to be successfully treated with salvage radiotherapy on the prostatic bed.
A.C.O.M. Advanced Center Oncology Macerata S.r.l.4 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2025年2月24日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 4
- 主要终点
- To evaluate the relationship between PSA levels (calculated between PSA levels measured before treatment and minimum PSA level measured during the observational period following the treatment) and prostatic bed (positive prostate (B +) and negative prostate (B-). The 64CuCl2-PET is obtained positive (B +) when in the prostate bed a detectable focal absorption is manifested because superior to the value of the background; otherwise it is judged negative (B-).
研究概览
简要总结
The primary objective is to evaluate the diagnostic accuracy of PET with 64CuCl2 in the diagnosis of local recurrence of prostatic carcinoma after radical prostatectomy, in patients negative to traditional methods.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age>=45 years at the time of enrollment.
- •Previous execution mpMRI and/or US performance not older than 30 days.
- •Karnofski Index >= 80%
- •Absence of other relevant comorbidities (see: exclusion criteria).
- •Full ability to understand the information reported in the informed consent sheet.
- •Full ability to sign informed consent.
- •Previous documented histological diagnosis of primitive prostate adenocarcinoma.
- •Previous prior radical prostatectomy surgery.
- •Zeroing of circulating PSA values.
- •Presence of biochemical relapse documented by an increase in circulating PSA values in two consecutive determinations (values between 0.2 ng/ml and 1 ng/ml)
- •Absence of distant metastatic lesions not detectable by previous mpMRI and PET/CT imaging tests (18F-choline and/or PSMA).
- •Negative clinical history for other previous or current neoplastic diseases, with the exception of non-melanoma skin carcinomas.
- •Previous execution 18F-FCH PET and/or PSMA PET not older than 30 days.
- •Patients to be treated with salvage radiotherapy to the prostate bed.
排除标准
- •Anemia with Hb <9 gr/dl
- •Major surgery performed in the previous 120 days.
- •Presence of lesions in the prostatic bed evidenced by previous mpMRI and/or US examinations.
- •Previous participation in clinical trials with exposure to ionizing radiation for therapeutic purposes.
- •Any condition, material, logistics, or Subjective, which, even in the opinion of the Principal Investigator, may condition the subject's compliance with the execution of the procedures established by the Protocol.
- •Inability to understand the contents of the information documentation for the subject.
- •Subject treated with ADT (orchiectomy, and/or LHRH agonists, and/or androgen antagonists).
- •Presence of symptoms or signs of sepsis and/or evidence of acute infections.
- •AST>1.5 times the upper limit of the normal range.
- •ALT>1.5 times the upper limit of the normal range.
- •Total bilirubin>1.5 times the upper limit of the normal range.
- •Copper metabolism diseases (Menkes’ disease, Wilson’s disease).
- •Subjects who have received chemotherapy in the previous 120 days.
- •Radiotherapy performed in the previous 120 days.
结局指标
主要结局
To evaluate the relationship between PSA levels (calculated between PSA levels measured before treatment and minimum PSA level measured during the observational period following the treatment) and prostatic bed (positive prostate (B +) and negative prostate (B-). The 64CuCl2-PET is obtained positive (B +) when in the prostate bed a detectable focal absorption is manifested because superior to the value of the background; otherwise it is judged negative (B-).
To evaluate the relationship between PSA levels (calculated between PSA levels measured before treatment and minimum PSA level measured during the observational period following the treatment) and prostatic bed (positive prostate (B +) and negative prostate (B-). The 64CuCl2-PET is obtained positive (B +) when in the prostate bed a detectable focal absorption is manifested because superior to the value of the background; otherwise it is judged negative (B-).
次要结局
- Calculation of the maximum variation of PSA in the subgroups of patients with PSA<0.5 and PSA between 0.5 and 1, through the ROC curve and evaluation of the ability to detect sites of recurrence.
- In each patient the impact that the positive results of 64CuCl2-PET out of the prostatic bed would have had on the therapeutic choice will be evaluated and tabulated, also taking into account the classification of the patient in R+/R-;
- Sensitivity, specificity, positive and negative predictive values and area under the curve (AUC) will be evaluated.
- The time between treatment beginning (baseline) and the achievement of the minimum value (NADIR) will be estimated through estimates of Kaplan-Meyer curves.
- The SUV values of the prostate bed index lesions will be correlated with the actual SRT response, in order to identify the SUV limits below which the uptake is not significant.
- Adverse events will be recorded and classified according to the EMA guidelines.
研究者
Contact Point
Scientific
A.C.O.M. Advanced Center Oncology Macerata S.r.l.
研究点 (4)
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