18F-FACBC PET-CT for the Detection and Staging of Recurrent Prostate Carcinoma (CA129356-01).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Number of Participants With False Positive Scans Within the Prostate Bed
研究概览
简要总结
Hypothesis:Anti-[18F]FACBC PET-CT will adequately detect local and extraprostatic recurrence, and lead to better characterization of disease status in restaging patients.
This is a study that will test a compound (chemical substance) that has a small amount of radioactivity attached to it. This substance has a natural tendency to go to prostate tissue. The substance is called [18]FACBC and it is given in the form of an injection into a vein. After the substance reaches the prostate, scans called PET or Positron Emission Tomography, are done. This is similar to having CAT scans or x-rays. Usually a compound called [18]FDG is used for PET scans but this substance is eliminated by the kidneys and cannot reach the prostate. This substance called [18]FACBC is not eliminated by the kidneys and may allow tumors in the prostate to be seen better. It is sometimes difficult to tell if a growth on the prostate is cancer with scans or x-rays that are usually done.
Anti-[18F]FACBC PET-CT will be compared to ProstaScint (In-capromab pendetide) which is the conventional imaging for prostate cancer. Investigators will be blinded of the intervention.
This study will look at how the [18]FACBC goes into the prostate tissue and determine its ability to detect recurrent 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
- Diagnostic
- 盲法
- Single (Investigator)
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
- •Patients must be 18 years of age or older.
- •Patients will have been originally diagnosed with localized (Stage T1c, T2, or T3 ) prostate carcinoma and have undergone what was considered definitive therapy for localized disease.
- •In the case of brachytherapy, cryotherapy, or external beam radiation, treatment will have occurred at least 2 years in the past to eliminate patients with so-called "PSA bump."
- •Patient will have suspicion of recurrent prostate carcinoma as defined by: ASTRO criteria of three consecutive rises of PSA or earlier if clinically appropriate, and/or nadir + 2.0 after radiotherapy, and/or greater than 0.3 after prostatectomy.
- •Ability to lie still for PET scanning
- •Patients must be able to provide written informed consent.
排除标准
- •Age less than
- •Greater than T3 disease in past
- •Prior prostatectomy or 2 years since brachytherapy, cryotherapy, or external beam radiation therapy.
- •Does not meet above criteria of suspicious PSA elevation
- •Inability to lie still for PET scanning
- •Cannot provide written informed consent.
- •Bone scan findings characteristic for metastatic prostate carcinoma
- •Less than 2 months since any prior prostate biopsy (to decrease false positive uptake from inflammation).
研究组 & 干预措施
FACBC PET-CT and ProstaScint CT
Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer will undergo an FACBC PET-CT scan and the ProstaScinct CT.
干预措施: FACBC (Drug)
FACBC PET-CT and ProstaScint CT
Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer will undergo an FACBC PET-CT scan and the ProstaScinct CT.
干预措施: ProstaScinct (Other)
结局指标
主要结局
Number of Participants With False Positive Scans Within the Prostate Bed
时间窗: Up to 5 years
Total number of participants with positive FACBC PET-CT and ProstaScint scans in the prostate bed that were confirmed as negative by biopsy and or follow up.
Number of Participants With False Positive Scans Outside the Prostate Bed
时间窗: Up to 5 years
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.
Number of Participants With True Negative Scans Within the Prostate Bed
时间窗: Up to 5 years
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as negative by biopsy and or follow up.
Number of Participants With True Negative Scans Outside the Prostate Bed
时间窗: Up to 5 years
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as negative by biopsy and/or follow up.
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma
时间窗: Up to 5 years
1. Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer outside the prostate bed. \[total number of true positives / total number of study participants confirmed to have prostate cancer outside the prostate bed (True positives + False negatives)\] 2. Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer outside the prostate bed. \[ total number of true negatives / total number of study participants confirmed to not have prostate cancer outside the prostate bed (True negatives + False positives)\] 3. Accuracy = (True positives + true negatives)/all tests 4. Positive predictive value = probability that subjects with a positive screening test truly have prostate cancer outside the prostate bed 5. Negative predictive value = probability that subjects with a negative screening test truly don't have prostate cancer outside the prostate bed
Number of Participants With False Negative Scans Within the Prostate Bed
时间窗: Up to 5 years
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans in the prostate bed that were confirmed as positive by biopsy and or follow up.
Number of Participants With True Positive Scans Outside the Prostate Bed
时间窗: Up to 5 years
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.
Number of Participants With False Negative Scans Outside the Prostate Bed
时间窗: Up to 5 years
Total number of participants with negative FACBC PET-CT and ProstaScint CT scans outside the prostate bed (extra-prostate) that were confirmed as positive by biopsy and/or follow up.
Number of Participants With True Positive Scans Within the Prostate Bed
时间窗: Up to 5 years
Total number of participants with positive FACBC PET-CT and ProstaScint CT scans in diagnosis of prostate cancer in the prostate bed validated by prostate biopsy and follow up.
Diagnostic Performance of Anti-[18F]FACBC PET-CT Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed
时间窗: Up to 5 years
1. Sensitivity = How well FACBC PET is able to correctly detect when there is prostate cancer in the prostate bed. i.e. total number of true positives / total number of study participants confirmed to have prostate disease in the prostate bed (True positives + False negatives) 2. Specificity = How well FACBC PET is able to correctly detect when there is no prostate cancer in the prostate bed. i.e. total number of true negatives / total number of study participants confirmed to not have prostate disease in the prostate bed (True negatives + False positives) 3. Accuracy = (True positives + true negatives)/all tests 4. Positive predictive value = the probability that subjects with a positive screening test truly have prostate carcinoma in the prostate bed 5. Negative predictive value = the probability that subjects with a negative screening test truly don't have prostate carcinoma in the prostate bed
次要结局
- Diagnostic Performance of ProstaScint Imaging in Detection of Recurrent Prostate Carcinoma in the Prostate Bed(Up to 5 years)
- Diagnostic Performance of ProstaScint Imaging in Detection of Extra-prostatic Recurrence of Prostate Carcinoma(Up to 5 years)
研究者
David M. Schuster, MD
Sponsor-Investigator
Emory University