A Single Arm Phase II Trial of Ultrahypofractionated Focal Salvage Radiotherapy for Isolated Prostate Bed Recurrence After Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 5
- 主要终点
- Biochemical relapsefree survival
研究概览
简要总结
The main objective of the trial is to explore the efficacy and safety of combining short-term androgen deprivation therapy (ADT) over 6 months to focal ultrahypofractionated salvage radiotherapy (SRT) delivered in 5 fractions to the site of local recurrence within the prostate bed after radical prostatectomy where multiparametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen (PSMA) PET/CT are used to precisely identify the local recurrence and compare it to previously published literature.
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 100 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Written informed consent according to ICH/GCP (International Council for Harmonisation/Good Clinical Practice) regulations before registration and prior to any trial specific procedures
- •Age ≥ 18 years at time of registration
- •WHO performance status 0-1
- •Lymph node negative adenocarcinoma of the prostate treated with radical prostatectomy (RP) at least 6 months before trial.Tumor stage pT2a-3b, R0-1, pN0 or cN
- •according to the Union for International Cancer Control (UICC) TNM
- •Evidence of measurable local recurrence at the prostate bed detected by PSMA PET/CT and mpMRI within the last 3 months. In case of unclear local recurrence, a biopsy confirmation is recommended.
- •Patient must have non-metastatic (N0, M0) disease, as defined by a lack of nodal or distant metastases seen on PSMA PET/CT scan
- •Patients must have non-castrate levels of serum testosterone (≥50 ng/dL).
- •Patients must not have previously received hormonal therapy (LHRH agonists, antiandrogen, or both, or bilateral orchiectomy).
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
排除标准
- •Persistent PSA (> 0.4 ng/mL) 4 to 20 weeks after RP
- •Previous hematologic or primary solid malignancy within 3 years prior registration with the exception of curatively treated localized non-melanoma skin cancer
- •Usage of products known to affect PSA levels within 4 weeks prior to start of trial treatment phase including any form of androgen suppression agents and androgen deprivation therapy
- •Bilateral hip prosthesis
- •Severe or active co-morbidity likely to impact on the advisability of SRT
- •Treatment with any experimental drug or participation within a clinical trial within 30 days prior to registration (exception: concurrent participation in the biobank studies is allowed)
研究组 & 干预措施
Single arm
Patients with locally recurred prostate cancer will receive a ultrahypofractionated stereotactic radiotherapy to the radiologically identified lesion (Dose: 5 fractions with 7Gray every second work week day) combined with an androgen deprivation therapy (LHRH-agonist / -antagonist) for 6 months.
干预措施: Ultrahypofractionated salvage radiotherapy to a local recurrence after radical prostatectomy (Radiation)
Single arm
Patients with locally recurred prostate cancer will receive a ultrahypofractionated stereotactic radiotherapy to the radiologically identified lesion (Dose: 5 fractions with 7Gray every second work week day) combined with an androgen deprivation therapy (LHRH-agonist / -antagonist) for 6 months.
干预措施: Androgen deprivation therapy (Drug)
结局指标
主要结局
Biochemical relapsefree survival
时间窗: 2 years
The initial prostate specific antigen (PSA) at time of registration will be the starting point. Freedom from biochemical progression is counted from the day of registration to the day of either first recorded biochemical progression as defined below, clinical progression or death due to clinical progression. Biochemical relapsefree survival measured with PSA (prostate specific antigen) lab testing at 1, 3, 6, 12, 18 and 24 months after radiotherapy. The duration of biochemical relapsefree survival is measured and documented in months for each patient. A biochemical recurrence is defined by any confirmed PSA rise above 0.20 ng/mL with a confirmatory rise at least 2 weeks later. For those patients whose PSA does not drop below 0.20 ng/mL at time of first response assessment at 3 months are considered as non-responders to treatment and are considered to have a biochemical recurrence in case a second measurement at least 2 weeks later confirms a rising PSA above this level.
次要结局
- Acute side effects of grade 3 or higher(90 days)
- Metastasis-free survival(2 years)
- Clinical progression-free survival(2 years)
- Late side effects(After 90 days up to 2 years (after acute side effects, see outcome 2))
- Quality of life ( EORTC Quality of life PR25)(2 years)
- Quality of life (EORTC Quality of life questionnaire C-30 version 3)(2 years)