Prospective Evaluation of 68-Ga-PSMA -PET and Early PSA Kinetics During Salvage Radiotherapy for Personalizing the Management of Men With Relapse of Prostate Cancer After Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Assessment of PSA response during radiotherapy.
研究概览
简要总结
This is an open-label, phase II trial in patients with PSA recurrence after prostatectomy. Patients entering the study will all receive initial 50 Gray (Gy) radiotherapy (25 x 2Gy) to the prostate bed and thereafter be classified as either responders or non-responders depending on PSA response at fifth week of radiotherapy.
A 68-Ga- PSMA-PET is done before start of radiotherapy, and analyzed before fifth treatment week in order to identify cancer lesions in patients with poor PSA response. Patients with PSA response after 5 weeks of radiotherapy will not receive any subsequent therapy, whilst patients with poor PSA response may be in need for additional therapy such as radiotherapy to lymph node metastases and/or boost fractions to local recurrence. Patients with more than 3 lymph node metastases or distant metastases will not receive any more radiotherapy, but individualized systemic therapy will be started.
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
- •Histological evidence of prostate cancer in the radical prostatectomy specimen
- •At least 2 rising PSA values, of which the last ≥ 0.15 ng/ml
- •Tumor, regional nodes, metastasis (TNM): any T, N0/x, M0/x
- •Age: 18 years or older
- •World Health Organization (WHO) performance status 0-1
- •Life expectancy > 10 years
- •Adequate laboratory findings: hematological: hemoglobin > 90 g/L (may be transfused to maintain or exceed this level) absolute neutrophil count (ANC) ≥ 1,0 x 109/L, platelets ≥ 75 x 109/L hepatic: bilirubin ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALAT) ≤ 5 x ULN renal: creatinine ≤ 1.5 x ULN
- •Signed written informed consent
- •The patient must be able to comply with the protocol
排除标准
- •Evidence of metastasis on imaging or in specimen (e.g. N1 at lymph-node dissection)
- •Prior or ongoing treatment with hormones (antiandrogens, GnRH)
- •Prior radiotherapy to the pelvis
- •Previous malignancy other than prostate cancer and basalioma the past 5 years.
- •Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart failure
- •Severe pulmonary disease e.g. pulmonary fibrosis
- •Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial
结局指标
主要结局
Assessment of PSA response during radiotherapy.
时间窗: Is evaluated once weekly during radiotherapy, duration of radiotherapy is 35 days; 70 Gy in 2 Gy fractions.
Tumor detection rate measured with Ga-PSMA-PET in non-responders versus responders.
时间窗: PSA response is evaluated after 5 weeks of radiotherapy. Ga-PSMA-PET at baseline is compared in the PSA-responder group as compared to the non-responder group
次要结局
未报告次要终点