The Role of 68Gallium PSMA-11 in Biochemical Recurrence in Prostate Cancer and in Known Metastatic Prostate Cancer and in the Evaluation of Treatment Response After Salvage Therapy
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Residual prostate cancer
研究概览
简要总结
The goal of this research is to examine the ability of Gallium-68 (68Ga) Prostate-Specific Membrane Antigen-11 (PSMA-11) positron emission tomography/computed tomography (PET/CT) to detect sites of recurrent prostate cancer in patients with biochemical recurrence previously treated with radical prostatectomy (RP) or external beam radiation (EBRT) and to assess treatment response to subsequent salvage therapy.
详细描述
In developed countries, prostate cancer is the most common malignancy in men and the third leading cause of death in men. Following primary therapy for prostate cancer, a substantial number of patients will recur either locally in the pelvis or in extra pelvic locations. Approximately 20-30% of patients' status post RP will recur and up to 60% patients treated with EBRT will recur, as detected by rising serum levels of prostate specific antigen (PSA) after original therapy. This phenomenon is referred to as biochemical recurrence (BCR), as the elevated PSA usually occurs in advance of obvious clinical or radiologic evidence.
This study is designed to evaluate the performance of 68Ga PSMA-11 PET/CT in detecting the location (localized versus extra pelvic) of BCR and advanced metastatic prostate cancer compared to conventional imaging. In addition, we will evaluate its performance in assessing interim and post salvage therapy response compared to conventional imaging, including pelvic magnetic resonance imaging (MRI), computed tomography (CT), and bone scintigraphy.
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
- 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
- •Patients with suspected BCR of prostate cancer following initial treatment with either prostatectomy or definitive EBRT of the prostate or patients with known metastatic prostate cancer who have failed systemic therapy.
- •Patients being considered for salvage therapy.
- •Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Patients must be medically stable as judged by the patient's physician.
- •Patients must be able to lie still for 20-40 minutes for the PET/CT scans.
- •Ability to understand and the willingness to sign a written informed consent.
- •Patients with BCR and no known lesions should not be on antiandrogen therapy at the time of scans. Patients with known metastases who are currently being treated with anti-androgen therapy may remain on this medication.
排除标准
- •Patients who have or have had a biopsy proven concurrent other malignancy, excluding skin cancers.
- •Patients may not weigh more than the maximum weight limit for the PET /CT scanner table (> 200 kg or 440 pounds).
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga PSMA-
- •Furosemide will not be administered to patients with known allergy.
- •Patients must not be claustrophobic.
研究组 & 干预措施
Patients with suspected BCR or metastatic prostate cancer
Patients with suspected BCR or metastatic prostate cancer
干预措施: 68Ga PSMA-11 injection (Drug)
Patients with suspected BCR or metastatic prostate cancer
Patients with suspected BCR or metastatic prostate cancer
干预措施: Positron Emission Tomography/Computed Tomography (Procedure)
结局指标
主要结局
Residual prostate cancer
时间窗: Up to 3 years
For imaging during or after salvage therapy, existence of residual prostate cancer will be determined for each patient on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.
Location of recurrence
时间窗: Up to 3 years
Localized vs extra-pelvic recurrence will be determined for each patient based on 68Ga PSMA-11 PET/CT and standard-of-care radiological imaging.
次要结局
未报告次要终点
研究者
Dana Mathews
Professor
University of Texas Southwestern Medical Center