2024-519358-35-00招募中3 期
An open-label phase 2/3 study to analyse the feasibility and evaluate the safety of intravenous administration of 99mTc-PSMA-T4 in patients with prostate cancer
Narodowe Centrum Badan Jadrowych3 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年1月29日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- The diagnostic method will be deemed a feasible approach if at least 80% of subjects in each cohort fulfil the criteria of sensitivity and specificity (for cohorts A and B only, due to lack of negative results in cohort C as consequence of inclusion criteria) of [99mTc]Tc-PSMA-T4 multi-SPECT/CT – detection of all lesions that are pathologically or radiologically confirmed or suspicious in other modalities recommended in a particular clinical situation.
研究概览
简要总结
The objective of this study is to evaluate the feasibility and safety of [99mTc]Tc-PSMA-T4 in the diagnosis and treatment planning of prostate cancer and its metastases.
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Phase 2,Open-Label Study,Evaluate the Feasibility and Safety of Intravenous PSMA-T4,Prostate Cancer
- 盲法
- None
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
- •18 years of age or older. • PS ECOG < 2 • Prior diagnosis of any type of prostate cancer with a Gleason score (GlS) above
- •Confirmatory prostate biopsy within 12 weeks (time from pathological diagnosis as PCA date of pathological description to the time of signing the patient's informed consent to participate in the study), only for cohorts A and B. • Pelvic mpMRI prostate with PIRADS 2.1 score within 12 weeks before screening, only for cohorts A and B • Willingness to participate in this study and to provide written informed consent. Additional inclusion criteria for each cohort: Cohort A: • Intermediate risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer. • Greater than 10% chance of lymph node involvement assessed using the Memorial Sloan Kettering nomogram for probability of lymph node involvement in prostate cancer patients. • CT of the chest, abdomen and pelvis and bone scan within 12 weeks before screening in the unfavorable risk PC subgroup. • No prior treatment for prostate cancer. Cohort B: • High or very high-risk disease as defined by the most up-to-date version of National Comprehensive Cancer Network Guidelines for Prostate Cancer. • CT of the chest, abdomen and pelvis and bone scan within 12 weeks before screening in the unfavorable risk PC subgroup. • No prior treatment for prostate cancer.Cohort C: • Biochemical failure after radical prostatectomy defined as failure of PSA to fall to undetectable levels (PSA persistence) or undetectable PSA after RP with a subsequent detectable PSA that increases on 2 or more determinations (PSA recurrence) OR biochemical failure after definitive radiotherapy based on Phoenix Consensus OR radiographic evidence of metastatic disease without PSA persistence/recurrence OR clinical symptoms suggesting distant metastases.
排除标准
- •A subject will be excluded if ANY of the following criteria are met: • No histopathological confirmation of prostate cancer. • Patients with pacemakers or metal parts that prevent pelvic MRI to confirm the presence of prostate cancer. • Abnormal liver function including a significant increase of liver enzymes like: ALAT, ASPAT, alkaline phosphatase (AP) greater than 5x upper limit normal (ULN) and an increase in bilirubin greater than 2x ULN. • Renal impairment including eGFR <30 ml / min. • Within 6 months before inclusion into the study: myocardial infarction, other cardiac events requiring hospitalization (unstable angina, etc.), cerebrovascular accident, transient ischemic attack, acute stroke, pulmonary embolism or deep vein thrombosis. • Prior early or locally advanced malignancy after definitive treatment with at least 5-year period without evidence of disease. • Malignancy with distant metastases. • Acute congestive heart failure or severe arrhythmia (like ventricular arrhythmia), second or higher degree atrio-ventricular (AV) heart block. An active infection that the investigator deems sufficient to exclude the patient from the study, including but not limited to urinary tract infections, respiratory tract infections, and diabetic foot infections with osteomyelitis.
结局指标
主要结局
The diagnostic method will be deemed a feasible approach if at least 80% of subjects in each cohort fulfil the criteria of sensitivity and specificity (for cohorts A and B only, due to lack of negative results in cohort C as consequence of inclusion criteria) of [99mTc]Tc-PSMA-T4 multi-SPECT/CT – detection of all lesions that are pathologically or radiologically confirmed or suspicious in other modalities recommended in a particular clinical situation.
The diagnostic method will be deemed a feasible approach if at least 80% of subjects in each cohort fulfil the criteria of sensitivity and specificity (for cohorts A and B only, due to lack of negative results in cohort C as consequence of inclusion criteria) of [99mTc]Tc-PSMA-T4 multi-SPECT/CT – detection of all lesions that are pathologically or radiologically confirmed or suspicious in other modalities recommended in a particular clinical situation.
次要结局
- Positive and negative predictive value: Positive predictive value defined as number of true positives x 100% / number of true positives + number of false positives Negative predictive value defined as number of true negatives x 100% / number of true negatives + number of false negatives. Safety: Frequency of adverse events (AEs).The procedure-related AEs will be recorded during the 24h of the follow-up period in each case,no later than 48h after drug administration.Dosimetry, Feasibility.
研究者
Sponsor
Scientific
Narodowe Centrum Badan Jadrowych
研究点 (3)
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