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
- 1
- 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
研究组 & 干预措施
Radiotherapy
干预措施: External radiation therapy (Radiation)
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