Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy: a Randomized Phase III Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 374
- 试验地点
- 3
- 主要终点
- Failure-free survival (FFS).
研究概览
简要总结
A randomized phase III trial to study the effect of adding lymph node irradiation in patients with poor prostate-specific antigen (PSA) response during salvage radiotherapy for biochemical recurrence (0.15 ≤ PSA <0.70 ng/ml) after prostatectomy.
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
- •Life expectancy > 10 years
- •Age ≥18 years.
- •World Health Organization (WHO) performance status 0-
- •Estimated life expectancy >10 years.
- •Histological evidence of prostate cancer in the prostatectomy specimen
- •Primary tumor, regional nodes, metastasis (TNM): any primary tumor (pT), pathologically node-negative (pN0), M
- •Biochemical Recurrence (BCR) after prostatectomy, with 0.15 ≤ PSA <0.70 ng/ml.
- •Patients must be able to comply with the protocol.
- •Signed informed consent.
- •Adequate laboratory findings (Haemoglobin (Hb) >90g/L, absolute neutrophil count >1.0x109/L, platelets >75x109/l, bilirubin <1.5x upper limit of normal (ULN), alanine aminotransferase (ALAT) <5x ULN and creatinine <1.5 ULN).
排除标准
- •Metastases (regional lymph nodes or distant)* diagnosed with imaging.
- •Prior or ongoing hormonal therapy (antiandrogens or gonadotropin releasing hormone).
- •Prior radiotherapy to the pelvis.
- •Prior malignancy other than prostate cancer and basalioma in the past five years.
- •Clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) class III-IV congestive heart failure.
- •Severe pulmonary disease.
- •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
Continued salvage radiotherapy + lymph node irradiation (non responders)
Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present) + the addition of lymph node irradiation (46 Gy/23 fractions) given in sequence. Total number of fractions: 35 + 8 = 43 with 15 of the lymph node irradiation fractions delivered concomitant with the prostate bed/local recurrence irradiation. These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy.
干预措施: Radiation to the prostate bed with or without addition of radiation of lymph node irradiation. (Radiation)
Continued salvage radiotherapy (non responders)
Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as non responders according to weekly PSA measurements during the first 4 weeks of radiotherapy.
干预措施: Radiation to the prostate bed with or without addition of radiation of lymph node irradiation. (Radiation)
Continued salvage radiotherapy (responders)
Continued salvage radiotherapy as initially planned (to 70.0 Gy/73.5 Gy in 35 fractions to the prostate bed/local recurrence if present). These patients are classified as responders according to weekly PSA measurements during the first 4 weeks of radiotherapy, and are not followed according to the study protocol, follow up according to clinical practice.
结局指标
主要结局
Failure-free survival (FFS).
时间窗: FFS after SRT, with failure defined as either biochemical or clinical recurrence (imaging or biopsy confirmed). FFS is calculated from the randomization date (arms A and B) until end of follow up (month 60 after
Failure-free survival after salvage radiotherapy (SRT), with failure defined as either biochemical, defined as verified PSA level of ≥ 0.2 ng/ml above the post-radiotherapy PSA nadir value or clinical Recurrence, imaging or biopsy confirmed.
次要结局
- Systemic treatment-free survival.(Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).)
- Distant metastasis-free survival.(Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).)
- Numbers of patients with acute toxicity (≤ 3 months after end of salvage radiotherapy).(Up to 3 months after end of salvage radiotherapy.)
- Prostate cancer specific survival.(Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).)
- Overall survival.(Is evaluated from the randomization date (arms A and B) until end of follow up (month 60 after end of radiotherapy).)
- Numbers of patients with late toxicity (> 3 months to 5 years after end of salvage radiotherapy).(After 3 months after end of salvage therapy until end of follow up at month 60 after end of salvage therapy.)
- Patients self-esteem of quality of life.(Quality of life evaluated using questionnaire by the European Organisation for Research and Treatment of Cancer (EORTC), questionnaire is QLQ - PR25. Is done at baseline, at end of radiotherapy (43 days in Arm A, 35 days in Arm, month 12, 24, and 60.)
- Patients self-esteem of quality of life.(Quality of life evaluated using questionnaire by the European Organisation for Research and Treatment of Cancer (EORTC), questionnaire is QLQ-C30. Is done at baseline, at end of radiotherapy (43 days in Arm A, 35 days in Arm B), month 12, 24, and 60.)