Phase 2 Trial of NanoPac Focal Therapy for Prostate Cancer in Subjects Undergoing Radical Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events
研究概览
简要总结
This study evaluates the use of NanoPac injected directly into the prostate lesion in men with prostate cancer.
详细描述
NanoPac is very small (submicron) particles of the chemotherapy drug, paclitaxel, which is administered intravenously in a number of types of cancer. These submicron particles are injected directly into solid tumors to target cancer at the site of disease with less systemic exposure than intravenously administered chemotherapy. In this study, this submicron particle paclitaxel will be injected directly into the prostate lesion in men with prostate cancer scheduled for prostatectomy on up to three different occasions. All subjects in the study will receive NanoPac and will be evaluated to see if NanoPac is safe, well-tolerated, and has an impact on prostate cancer.
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
- •At least 18 years of age;
- •Histopathologically proven adenocarcinoma of the prostate:
- •Localized cancer;
- •Subjects with tumors classified as <T3 per TNM classification, Gleason score≥ 6;
- •Prostate tumor must be able to be visualized on mpMRI;
- •Already considered to be candidate for radical prostatectomy;
- •Considered appropriate for treatment with paclitaxel therapy;
- •Laboratory requirements:
- •WBC >2500/mm3
- •Neutrophil >1500/mm3
- •Hemoglobin >10 mg/dL
- •Platelet >100,000/ mm3
- •AST and ALT <2.5 x ULN
- •Total bilirubin <1.5 x ULN
- •Calculated creatinine clearance ≥ 30 ml/min
- •Normal PT/INR and PTT;
- •ECOG of 0 or 1;
- •International Prostate Symptom Score (I-PSS) less than or equal to 20;
- •If sexually active, willing to use double condoms from time of NanoPac injection until prostatectomy;
- •Agree to all study procedures and provide signed informed consent;
排除标准
- •Evidence of locally advanced or metastatic disease;
- •Prostate size ≥ 50 cc;
- •Prior prostatectomy, including surgery for any benign condition (such as TURP);
- •Anticipated use of concomitant chemotherapy (other than the protocol specified agents), immunotherapy, or systemic use of hormonal therapy (such as GnRH analogs, antiandrogens, androgen receptor inhibitors, and 5-α reductase inhibitors) while on study prior to surgery;
- •Treatment with a prior investigational medication within 30 days of first dose of study agent;
- •Any previous local treatment of the prostate (e.g. radiation, HIFU, cryotherapy, Focal Irreversible Electroporation, Photodynamic Therapy, Laser Induced Thermometry);
- •Any other condition (e.g., psychiatric disorder) that, in the opinion of the Investigator, may interfere with the subject's ability to comply with the study requirements or visit schedule;
- •Known sensitivity to any of the study agent components;
- •History of prior malignancy that has not been in remission for >5 years, with the exception of basal cell or squamous cell carcinoma.
研究组 & 干预措施
NanoPac
Direct injection of NanoPac at 15 mg/mL at a volume not to exceed the volume of the prostate cancer lesion (no more than 10% of total prostate volume). NanoPac will be administered on up to three occasions, with at least 28 days between each dose.
干预措施: NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events
时间窗: Day 1 to Day 85
Treatment emergent adverse events (including changes in laboratory assessments, physical examination findings, and vital signs)
次要结局
- Tumor Response Based on Change in Image Volume on mpMRI(Up to 1 month prior to Consent and Day 85)
- Change in PI-RADS Score(Up to 2 weeks prior to Day 1 and Day 85)
- Tumor Response Based on Histologic Evaluation of Biopsied Prostate Samples (Gleason Score)(Up to 2 weeks prior to Day 1 and Day 92)
- Tumor Response Based on Change in Percentage of Sample Considered Adenocarcinoma(Up to 2 weeks prior to Day 1 and Day 92)
- Tumor Invasion Into Surrounding Tissues(Up to 1 month prior to Consent and Day 85)
- Change in PSA Density(Up to 2 weeks prior to Day 1 and Day 85)
- Effect on Tumor Presence in Lymph Nodes(Up to 2 weeks prior to Day 1 and Day 92)
- Concentration of Paclitaxel in the Systemic Circulation Post-injection(Days 1, 8, 15, 29, 36, 43, 50, 57, 64, 71, and 85)
- Presence or Absence of Paclitaxel in Ejaculate(Days 15, 43, 57, and 85)
- Presence or Absence of Paclitaxel in Tissues Obtained at Prostatectomy(Day 92)