Efficacy of Posluma PET Scan in Evaulation and Monitoring of Patients Undergoing Focal Therapy for Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 主要终点
- Diagnostic performance of Posluma PSMA PET scan for prostate cancer after focal therapy
研究概览
简要总结
To determine the effectiveness of Posluma PET Scan for monitoring prostate cancer patients after targeted treatment, including how accurately it can detect any remaining or returning cancer after about 12 months post-treatment.
详细描述
This Phase II study will employ Posluma PSMA PET scans both preoperatively, for evaluation of lesions prior to focal therapy, and postoperatively, for monitoring recurrence and verifying treatment success. Imaging findings from Posluma PET will be compared with standard MRI and biopsy results to validate Posluma PET as an advanced diagnostic tool for improving PCa detection in patients undergoing focal therapy as well as postoperative follow-up after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Diagnosis: Histologically confirmed PCa.
- •Risk Profile: Intermediate-risk , organ-confined PCa
- •Eligibility for Focal Therapy: Determined to be an appropriate candidate for focal therapy based on clinical evaluation.
- •Age: 18 years or older.
- •Life Expectancy: Expected survival of at least 10 years.
- •Informed Consent: Ability to understand and willingness to sign the informed consent form.
排除标准
- •Previous Treatment: Prior treatment for PCa, including radiation therapy, chemotherapy, focal therapy, or androgen deprivation therapy.
- •Severe Comorbid Conditions: Presence of severe comorbid conditions that may interfere with study participation, such as uncontrolled cardiovascular, renal, hepatic, or metabolic diseases.
- •Contraindications to Imaging: Known hypersensitivity to components of the Posluma PSMA radiotracer, or inability to undergo PET or MRI imaging due to medical or anatomical constraints (e.g., severe claustrophobia, metallic implants incompatible with MRI).
研究组 & 干预措施
Posluma PET
Participants will undergo Posluma PSMA PET scans at two time points: preoperatively to evaluate the extent of disease prior to focal therapy and postoperatively for monitoring treatment success and detecting potential recurrence. The Posluma PET imaging will be conducted on a PET/CT scanner with optimized protocols for PCa lesion detection. PET scan data will be analyzed in comparison with MRI and biopsy results. All imaging will be performed at UCSD, ensuring consistent imaging quality and scanner calibration across all patients.
干预措施: Posluma PET (Diagnostic Test)
结局指标
主要结局
Diagnostic performance of Posluma PSMA PET scan for prostate cancer after focal therapy
时间窗: 12 months
To determine the sensitivity and specificity of the Posluma PSMA PET scan in detecting residual or recurrent prostate cancer lesions approximately 12 months after focal therapy, compared to MRI and biopsy data.
Accuracy of Posluma PSMA PET Imaging for Detection of Residual and Recurrent Disease for Prostate Cancer
时间窗: 12 months
To evaluate whether Posluma PSMA PET imaging can accurately detect residual or recurrent disease measured by comparison with MRI and biopsy results
次要结局
未报告次要终点
研究者
Aditya Bagrodia
Principal Investigator
University of California, San Diego