Optimizing the Management of High-risk and Unfavorable Intermediate-risk Disease: the Use of Advanced Imaging, Trans-perineal Mapping Biopsies, and Dual-strength Brachytherapy Sources to Minimize Radiation Dose to Normal Tissues
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Frequency of treatment-related GU adverse effects
研究概览
简要总结
Multi-modality therapy that includes a brachytherapy implant improves outcomes in locally advanced prostate cancer when compared to other radiation-based treatments, but is also associated with more adverse side effects. The goal of the OPTiMAL trial is to reduce these side effects by using advanced imaging and biopsy techniques to locate cancer and deliver precision radiation therapy, while not compromising the unprecedented high cure rates obtained for the brachytherapy arm of the Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy (ASCENDE-RT) randomized control trial.
Additionally, some applied research in genetics, pathology and medical imaging is included. Novel medical imaging methods, namely, multi-parametric magnetic resonance imaging (MRI), multi-parametric trans-rectal ultrasound (TRUS), prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) are used for re-staging of prostate cancer. This is followed by trans-perineal biopsy to locate cancerous areas of the prostate with greater precision compared to conventional biopsy. Results from imaging are compared to those from biopsy to develop image-based cancer detection methods.
详细描述
Purpose:
The purpose of OPTiMAL is to combine new imaging and treatment methods to reduce the incidence and severity of the genito-urinary (GU) side effects associated with radiation-based, multimodality treatment for men with locally advanced prostate cancer (PCa). OPTiMAL was inspired by the highly successful Androgen Suppression Combined with Elective Nodal and Dose Escalated Radiation Therapy (ASCENDE-RT) randomized control trial, in which men who were randomized to a low-dose-rate brachytherapy (LDR-PB) boost experienced unprecedented high cure rates, but also had more side effects and a slightly greater decrease in quality-of-life (QoL) scores when compared to the standard arm which used a dose-escalated external beam (DE-EBRT) boost.
Hypothesis:
By allowing a higher radiation dose to the cancer while delivering lower dose to healthy tissue, more accurate cancer localization will result in a decrease in adverse effects and better QoL, when compared to the men in the experimental arm of ASCENDE-RT.
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Patients must have histologically-proven prostate cancer
- •Patients must meet either: a. National Comprehensive Cancer Network (NCCN) definition of high-risk disease or b. Intermediate-risk disease with at least 3 points using the following scale: One point each for clinical stage = T2b-c, iPSA >7 ng/mL, and Gleason grade group 2 (overall Gleason sum 3+4 =7), Two points for Gleason grade group 3 (overall Gleason sum 4+3 =7).
- •Patients must have N0 M0 status on the basis of technetium bone scan and computed tomography (CT) scan of the pelvis
排除标准
- •Those with pre-intervention prostate specific antigen (iPSA) above 100 ng/mL.
- •Those who have received prior surgical treatment for prostate cancer including transurethral resection of the prostate (TURP), transurethral resection of the bladder neck (TURB), cryotherapy, laser ablation, or high frequency ultrasound (HIFU)
- •Those with an estimated life expectancy of less than 5 years with an Eastern Cooperative Oncology Group (ECOG ) performance status above 0-2
- •Those with prior radiation therapy to the pelvis.
- •Those who have received androgen deprivation therapy (ADT) prior to registration.
- •Contraindication to high-dose pelvic irradiation, Luteinizing hormone-releasing hormone (LHRH) agonists, or nonsteroidal antiandrogen therapy
- •Those who are not able to participate in an MRI scan (i.e. significant renal impairment that would preclude the use of contrast agent, some patients with cardiac pacemaker, wires, or defibrillator; artificial heart valve; brain aneurysm clip; electrical stimulator for nerves or bones; ear or eye implant; implanted drug infusion pump; coil; catheter, or filter in any blood vessel. Some men with metallic prosthesis; shrapnel, bullets, or other metal fragments retained in the body)
- •Those who are not able to participate in a PET/CT scan
- •Cancer survivors who do not meet all three of the following criteria: a) The patient has undergone potentially curative therapy for all prior malignancies. b) There has been no evidence of recurrence for at least five years following potentially curative therapy. (For non-melanoma skin cancer the five-year requirement does not apply.) and c) The patient is considered by the treating physician to be at low risk of recurrence from prior malignancies.
- •Those who are on anticoagulation therapy (blood thinners) and are unable stop this medication safely for at least 5 days.
结局指标
主要结局
Frequency of treatment-related GU adverse effects
时间窗: Analysis to be done at median follow-up of 2 years
Cumulative frequency of Physician-reported grade 2 and above GU adverse events (scored using a modified CTCAE - Common Terminology Criteria for Adverse Events- scale).
次要结局
- Trans-perineal biopsy and imaging correlation(2 years)