Technical Feasibility of a Randomized Pilot Study of Radiosurgery for the Treatment of Non-metastatic Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
This is a prospective, interventional pilot study to evaluate the feasibility of randomizing patients diagnosed with prostate cancer to different treatment schemes according to their risk.
Patients with a diagnosis of prostate adenocarcinoma (confirmed by biopsy), without signs of metastasis outside the pelvis in the staging study and without prior radiotherapy (RT) to the pelvic region will be recruited.
The definition of risk group from the international guide National Comprehensive Cancer Network will be used.
- Low risk
- Favorable intermediate risk
- Unfavorable intermediate risk
- High risk The use of hormonal blocking will be at the discretion of each treating physician.
The radiotherapy simulation will be carried out according to the institutional protocol for the treatment of prostate cancer.
According to the risk group of the patients, the following randomization will be carried out:
- Low / intermediate favorable risk: Patients will be randomized to receive SBRT to prostate 36.25 Gy in 5 fractions, alternate days or weekly, with VMAT (technique and 6 Mega-voltage (MV) X-rays vs to SBRT to prostate 26 Gy in 2 fractions, 1 weekly fraction, with VMAT technique and 6 Mv X-rays. The volumes to be treated, ¨Clinical target volume¨ (CTV) will be defined as the prostate, according to the consensus of the Radiation Therapy Oncology Group (RTOG).
- Intermediate unfavorable risk and high risk: Patients will be randomized to receive SBRT to the prostate and seminal vesicles, 36.25 Gy in 5 fractions, alternate days or weekly, with VMAT technique and 6 MV X-rays vs SBRT to pelvis scheme of 25 Gy in 5 fractions with simultaneous integrated boost up to 36.25 to the prostate and seminal vesicles, with the same technique.
- Patients with positive pelvic node: Will be randomized to moderate hypofractionated RT , completing a dose of 44 Gy in 20 fractions to the pelvis with a simultaneous integrated boost up to 54-60 Gy in 20 fractions to metastatic lymphadenopathy and prostate with seminal vesicles, completing 60 Gy to prostate and seminal vesicles or to ultra hypofractionated RT to the prostate and macroscopic lymphadenopathy to 35 and 30-35 Gy respectively and 25 Gy in 5 fractions to the elective nodal areas.
详细描述
Background
Prostate cancer is the most common non-cutaneous neoplasm in men both worldwide and in Chile, being the third cause of death in our country. Radiation therapy (RT) is a well-validated curative treatment alternative for prostate cancer, generally being combined with androgen deprivation therapy in intermediate and high risk patients. Dose escalation of RT improves event-free survival and the need for new therapies in the future (continuous androgen deprivation). This dose escalation strategy involves long-term treatments (7 to 8 weeks) with high operational cost for the patient (stays, transportation, etc.) and radiotherapy services.
Hypofractionated RT (reduction of treatment fractions) has shown a similar safety profile and oncological results equivalent to dose escalation in several phase III studies, allowing the total treatment time to be reduced to 4-5 weeks and thus be a more convenient treatment for patients and the radiotherapy department. In the same way, radiosurgery or stereotaxic body radiotherapy (SBRT), is a highly conformed RT technique that significantly reduces the total treatment time (1-2 weeks of treatment). In recent years, the safety and efficacy of SBRT in low- and intermediate-risk prostate cancer has been proven in phase III studies; and in high-risk patients, its low toxicity profile and good biochemical control have been demonstrated in a systematic review. Since this radiotherapy technique has recently been introduced into clinical practice, there are different approaches in relation to the number of fractions used and volumes to be treated.
A pilot study was designed to evaluate the technical feasibility of implementing the randomization of patients who are candidates for radiosurgery between schemes previously used in the literature according to their risk and stage: 2 vs 5 fractions in low / intermediate risk patients include or not pelvic treatment in high-risk patients and a moderate hypofractionated treatment regimen of 20 vs 5 fractions in cN1 or higher patients.
Methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Histology confirmed prostate cancer
- •Disease confined to the pelvis by imaging CT (CT scan of chest, abdomen and pelvis and bone scan or prostate specific membrane antigen positron emission tomography (PET-PSMA) if required according to local guidelines)
- •Eastern Cooperative Oncology Group (ECOG) performance 0-1
- •Eligible for curative radiotherapy
排除标准
- •Metastasis beyond the pelvis
- •Poor performance ECOG 2-4
- •Cannot follow directions to prepare for simulation (bladder filling and rectal emptying)
结局指标
主要结局
Recruitment
时间窗: 12 months
Percentage of screened patients eligible recruited
Treatment protocol fidelity
时间窗: 12 months
Percentage of recruited patients receiving treatment according to protocol
Follow up
时间窗: 12 months
Percentage of recruited patients effectively followed according to protocol
次要结局
- Biochemical control(24 months)
- Change From Baseline In Quality Of Life (QoL) Total Score As Assessed By The Global Health Domain Of The European Organization Of Research And Treatment Of Cancer (EORTC)-Quality Of Life Questionnaire (QLQ)-C30(6,12 and 24 months)
- Change From Baseline In QoL Total Score As Assessed By The EORTC-QLQ-PR25 Sexual Activity And Functioning And Hormonal-Treatment-Related Symptom Subdomains.(6, 12 and 24 months)