A Pilot Study Comparing High-Dose Rate Brachytherapy and Stereotactic Ablative Radiotherapy as Monotherapy in Localized Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Feasibility of comparing stereotactic ablative radiotherapy (SABR) and high-dose rate brachytherapy (HDRB)
研究概览
简要总结
This phase II trial compares high-dose rate brachytherapy and stereotactic ablative radiotherapy as monotherapy in treating patients with prostate cancer that has not spread to other parts of the body (localized). High-dose rate brachytherapy delivers radiation directly into the prostate within a few minutes by a single radioactive seed through temporarily placed plastic catheters inside the prostate gland. Stereotactic ablative radiotherapy is an external beam radiation method that delivers large doses of radiation to the cancer in a short period of time, usually 5 treatments. This trial aims to find which of these two approaches is better in terms of patient-reported quality of life.
详细描述
PRIMARY OBJECTIVE:
I. To assess feasibility of a pilot non-randomized trial evaluating stereotactic ablative radiotherapy (SABR) and high-dose rate brachytherapy for localized prostate cancer.
OUTLINE: Patients elect to participate in arms 1 or 2.
ARM I: Patients undergo high-dose rate brachytherapy (HDR).
ARM II: Patients undergo SABR every other day for 5 treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months. Patients on active surveillance with evidence of disease progression are eligible to the protocol as long as they meet the eligibility criteria and have a recent prostate biopsy (within 9 months)
- •Low-risk and intermediate-risk patients are eligible according to the following guidelines:
- •Low and intermediate-risk disease defined as:
- •Clinical stage T1-T2 and Gleason =< 7 and prostate specific antigen (PSA) < 15 ng/ml
- •Lymph node evaluation by either computed tomography (CT) or magnetic resonance imaging (MRI) and bone scan are optional and are left at the discretion of the treating physician
- •Prostate MRI is recommended by not mandatory
- •No alpha reductase inhibitors use within 2 weeks of randomization. A washout period of 2 weeks is required prior to randomization
- •Eastern Cooperative Oncology Group status 0-1
- •Judged to be medically fit for brachytherapy by a radiation oncologist
- •Concurrent, neoadjuvant and/or adjuvant androgen deprivation therapy (ADT) is not permitted
- •Prostate volume by trans-rectal ultrasound (TRUS) =< 60 cc
- •International Prognostic Scoring System (IPSS) =< 20 (alpha blockers allowed)
- •Patients must sign a study specific informed consent form prior to study entry
- •Patients must by accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating center. Investigators must assure themselves that patients enrolled in this trial will be available for complete documentation of the treatment, adverse events, and follow up
- •Protocol treatment is to begin within 4 weeks of patient randomization
排除标准
- •Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, or other solid tumors curatively treated with no evidence of disease for >= 5 years
- •Prior or current bleeding diathesis
- •Radical surgery for carcinoma of the prostate, prior pelvic radiation, prior chemotherapy for prostate cancer, prior transurethral resection of the prostate (TURP), prior cryosurgery of the prostate
- •Stage T3b and evidence of nodal or distant metastatic disease on diagnostic CT, MRI or bone scan
- •Subjects who have plans to receive other concomitant or post treatment adjuvant antineoplastic therapy while on this protocol including surgery, cryotherapy, conventionally fractionated radiotherapy, hormonal therapy, or chemotherapy given as part of the treatment of prostate cancer
- •Severe, active co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- •Transmural myocardial infarction within the last 6 months
- •Acute bacterial for fungal infection requiring intravenous antibiotics at the time of registration
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
- •Hepatic insufficiency resulting in clinical jaundice and/or coagulations defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
- •Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immumo-compromised patients
- •Patients with history of inflammatory colitis (including Crohn's disease and ulcerative colitis) or collagen vascular diseases including rheumatoid arthritis and lupus are not eligible
- •Subjects who have a history of significant psychiatric illness
- •Men of reproductive potential who do not agree that they or their partner will use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills
研究组 & 干预措施
Arm I (HDR)
Patients undergo HDR.
干预措施: High-Dose Rate Brachytherapy (Radiation)
Arm I (HDR)
Patients undergo HDR.
干预措施: Quality-of-Life Assessment (Other)
Arm I (HDR)
Patients undergo HDR.
干预措施: Questionnaire Administration (Other)
Arm II (SABR)
Patients undergo SABR every other day for 5 treatments.
干预措施: Quality-of-Life Assessment (Other)
Arm II (SABR)
Patients undergo SABR every other day for 5 treatments.
干预措施: Questionnaire Administration (Other)
Arm II (SABR)
Patients undergo SABR every other day for 5 treatments.
干预措施: Stereotactic Ablative Radiotherapy (Procedure)
结局指标
主要结局
Feasibility of comparing stereotactic ablative radiotherapy (SABR) and high-dose rate brachytherapy (HDRB)
时间窗: 36 months
Feasibility is defined as success in enrolling patients, performing the procedures, reporting adverse effects, collecting and managing data across several institutions and patient compliance in completing health-related quality of life questionnaires.
次要结局
- Changes in patient reported Health-Related Quality of life (HRQoL)(Baseline up to 36 months)
- Incidence of adverse events(Baseline up to 36 months)
- Changes in patient-reported urinary toxicity(Baseline up to 36 months)
- Changes in patient-reported sexual toxicity(Baseline up to 36 months)
研究者
Lara Hathout, MD, FRCPC
Assistant Professor, Dept. of Radiation Oncology
Rutgers Cancer Institute of New Jersey