Tracer-Based Image Guided Surgery for Recurrent Prostate Cancer: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical progression-free survival (CPFS)
研究概览
简要总结
ADT with or without robot-assisted PSMA-radioguided surgery for patients with recurrent prostate cancer.
详细描述
Improving the oncological treatment outcomes in men with a biochemical recurrence after primary prostate cancer (PC) treatment that are diagnosed with a disease recurrence confined to the regional lymph nodes or local residual disease using Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography and Computed Tomography (PET/CT.)
The proposed trial randomizes patients with recurrent PC following primary PC treatment to either 6 months of ADT or Technetium-PSMA-radioguided salvage surgery plus 6 months of ADT. Although the optimal duration of ADT is unknown, a minimal duration of 6 months of ADT seems advisable in this setting and will be mandatory for both arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male, aged ≥ 18 years.
- •Hormone-sensitive recurrent prostate cancer after radical prostatectomy, external beam radiotherapy or brachytherapy
- •≤ 2 lymph node metastases or local residual disease within the pelvis with sufficient PSMA expression (≥2 times regional vascular activity level) as determined by PSMA-based PET
- •PSA-value < 4 ng/mL in case of a local recurrence and PSA < 3 ng/ml in case of (a) nodal recurrence(s)
- •Had a PSMA PET/CT within 90 days before surgery
- •Suitable for salvage surgery, as per institutional guidelines.
- •Charlson Comorbidity Index ≤ 4
- •World Health Organisation (WHO) performance status 0, 1, or
- •Written and signed informed consent.
排除标准
- •Other diagnosis of malignancy or evidence of other malignancy within 5 years before screening for this study (except non-melanoma skin cancer).
- •More than 2 lymph node metastases on PSMA PET/CT
- •Suspicion of local recurrent prostate cancer within the prostatic fossa not treatable by surgery
- •Non-regional lymphadenopathy (cM1a) or distant metastases (cM1b/c) as assessed by preoperative PSMA PET/CT.
- •Castration resistance defined by clinical or biochemical progression despite a combined androgen blockade
- •Known contraindications to hormone therapy, according to standard recommendations in force
- •Patient with a psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule
- •Ongoing androgen deprivation therapy (ADT) or within 6 months prior to surgery.
- •Severe claustrophobia interfering with PET/CT scanning.
- •Absence or withdrawal of an informed consent
研究组 & 干预措施
Arm A: ADT
Patients in arm A will receive standard 6 months of ADT according to current clinical guidelines.
干预措施: ADT (Drug)
Arm B: ADT + PSMA radioguided surgery
Patients in arm B will receive standard 6 months of ADT according to current clinical guidelines, and will undergo 99mTechnetium (99mTc)-based PSMA-radioguided salvage surgery.
干预措施: PSMA-radioguided surgery (Procedure)
Arm B: ADT + PSMA radioguided surgery
Patients in arm B will receive standard 6 months of ADT according to current clinical guidelines, and will undergo 99mTechnetium (99mTc)-based PSMA-radioguided salvage surgery.
干预措施: ADT (Drug)
结局指标
主要结局
Clinical progression-free survival (CPFS)
时间窗: 24 months
CPFS is defined as time between randomization and the appearance of a recurrence (any N1 or M1) as suggested by PSMA PET/CT or symptoms related to progressive PC, or death due to any cause
次要结局
- Metastasis-free survival (MFS)(24 months)
- Incidence of adjuvant therapy(10 years)
- Complications(30 and 90 days)
- Number of in-field recurrences(24 months)
- Biochemical progression-free survival (BPFS)(24 months)
- Castrate resistant prostate cancer (CRPC)(10 years)
- Overall survival (OS)(10 years)
- Patient reported QOL as per EORTC-QLQ C30(24 months)
- Specificity of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation(30 days)
- Patient reported QOL as per Expanded Prostate cancer Index Composite (EPIC) 26(24 months)
- Sensitivity of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation(30 days)
- Positive Predictive Value of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation(30 days)
- Negative Predictive Value of 99mTc-PSMA RGS for salvage surgery for recurrent PC compared to histologic evaluation(30 days)