Androgen Suppression With Stereotactic Body or External Beam Radiation Therapy (ASSERT): A Phase II Randomized Trial for Intermediate and High Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of subjects experiencing treatment-related acute and late toxicities, focussing on grade 3 and 4 complications, as assessed by the NCI CTCAEv4 and modified RTOG/SOMA toxicity scale.
研究概览
简要总结
Two radiation therapy techniques are commonly used for the treatment of intermediate and high risk prostate cancer: brachytherapy and external beam radiation therapy (EBRT). However, both have limitations. Brachytherapy, in which radioactive seeds are inserted into the prostate, produces excellent outcomes but is invasive and not all patients are eligible or willing to receive this treatment. EBRT, while gentle at the time of delivery, tends to be very prolonged and may have poorer outcomes than brachytherapy. This study will examine the use of stereotactic ablative radiotherapy (SABR), in which patients are given only a few, high dose radiation treatments. Treatments are short, non-invasive, applicable to patients not able to do brachytherapy, and may be more effective than conventional EBRT. This study will compare SABR with EBRT in terms of the rates of acute and late toxicities for each treatment, disease-free survival, and health-related quality of life measures.
详细描述
The current study is a randomized phase II study comparing high speed, single arc, LINAC-based prostate stereotactic ablative radiotherapy (SABR) with conventional external beam radiation treatment (EBRT), along with androgen suppression (AS), in men with intermediate and high risk prostate cancer, who are either unsuitable for or unwilling to have brachytherapy. The two primary objectives of the study are to assess the feasibility of randomization, and to compare the rates of acute and late toxicities. Should randomization prove feasible, and toxicities comparable, a future phase 3 trial will be pursued.
Primary objectives:
- To determine the proportion of eligible patients who are willing to be randomized
- To estimate and compare the proportions of acute and late toxicities, focussing on grade 3 and 4 complications of the treatment interventions as delivered in the British Columbia (BC) Cancer Agency
Secondary objectives:
- To compare the disease free survival as reflected in biochemical relapse free survival at five years between the two interventions
- To compare the health related quality of life as reflected in changes on the EPIC questionnaire between the two interventions
- To quantify the degree of intra-fraction motion with the proposed SABR technique
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Pathological diagnosis of prostate cancer within 365 days prior to registration.
- •Disease must be Canadian Consensus (GUROC) high and intermediate risk with probability of pelvic nodal involvements <15% by the Updated Partin Tables.
- •High risk is defined by any of: ≥T3a, PSA > 20, or Gleason ≥ 8
- •Intermediate risk is defined by: T1/T2 and/or Gleason ≤ 7 and/or PSA ≤20 and not low risk
- •Disease must be T1 or T2 clinically
- •Prostate specific antigen (PSA) and testosterone level (TTT) must be done not more than 60 days before registration. If androgen deprivation therapy is started before registration, PSA and TTT should be done not more than 60 days prior to commencement of androgen deprivation therapy.
- •For high risk patients, negative pelvis CT scan and bone scan for metastases not more than 60 days before registration. If androgen deprivation therapy is started before registration, pelvis CT scan and bone scan should be done not more than 60 days prior to commencement of androgen deprivation therapy. For intermediate risk patients, pelvis CT scan and bone scan are optional.
- •Commencement of androgen deprivation therapy is allowed before registration. However, the lead time must allow for completion of the radiation treatment within 6 months and 18 months of the androgen deprivation therapy treatment duration for intermediate and high risk disease respectively.
- •History/physical examination with digital rectal examination of the prostate within 60 days of registration or commencement of androgen deprivation therapy.
- •Life expectancy of at least 5 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- •No contraindication for 6 months and 18 months of androgen deprivation therapy respectively for intermediate and high risk disease.
排除标准
- •Clinical evidence of extra-prostatic disease extension
- •Clinical evidence of prostate volume > 90 cc prior to randomization
- •Prior history of inflammatory bowel disease
- •Prior history of invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. All patients with in situ carcinoma are eligible for this study (for example, carcinoma in situ of the oral cavity is eligible) except patients with carcinoma of the bladder (including in situ bladder cancer or superficial bladder cancer).
- •Previous pelvic radiation
- •Presence of a hip prosthesis
- •Evidence of pelvic nodal involvement or distant metastases
研究组 & 干预措施
SABR with androgen suppression
Stereotactic ablative radiotherapy (SABR) with a prescribed dose of 36.25 Gy in 5 fractions over 5 weeks (one treatment day per week). Zoladex ® for androgen suppression, taken for 6 months for patients with intermediate-risk prostate cancer, 18 months for patients with high-risk prostate cancer.
干预措施: stereotactic ablative radiotherapy (Radiation)
SABR with androgen suppression
Stereotactic ablative radiotherapy (SABR) with a prescribed dose of 36.25 Gy in 5 fractions over 5 weeks (one treatment day per week). Zoladex ® for androgen suppression, taken for 6 months for patients with intermediate-risk prostate cancer, 18 months for patients with high-risk prostate cancer.
干预措施: Zoladex ® (Drug)
EBRT with androgen suppression
Conventional external beam radiation therapy (EBRT) with a prescribed dose of 73.68 Gy in 28 fractions (5 treatment days per week over 5.5 weeks). Zoladex ® for androgen suppression, taken for 6 months for patients with intermediate-risk prostate cancer, 18 months for patients with high-risk prostate cancer.
干预措施: external beam radiation therapy (Radiation)
EBRT with androgen suppression
Conventional external beam radiation therapy (EBRT) with a prescribed dose of 73.68 Gy in 28 fractions (5 treatment days per week over 5.5 weeks). Zoladex ® for androgen suppression, taken for 6 months for patients with intermediate-risk prostate cancer, 18 months for patients with high-risk prostate cancer.
干预措施: Zoladex ® (Drug)
结局指标
主要结局
Number of subjects experiencing treatment-related acute and late toxicities, focussing on grade 3 and 4 complications, as assessed by the NCI CTCAEv4 and modified RTOG/SOMA toxicity scale.
时间窗: 5 years
次要结局
- Number of subjects with biochemical relapse free survival at five years as measured by PSA levels.(5 years)
- To compare the health related quality of life as reflected in changes on the EPIC questionnaire between the two interventions(5 years)
- To measure the mean prostate pre-fraction to post-fraction displacement, in millimeters, from CT scans done pre- and post-fraction.(at week 5 of radiotherapy (completion of radiotherapy))
研究者
Abraham Alexander
Clinical assistant professor, Radiation Oncologist
University of British Columbia