Is Hypofractionated Whole-Pelvis Radiotherapy (WPRT) as Well Tolerated as Conventionally-Fractionated WPRT in Prostate Cancer Patients? (HOPE-Trial)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 58
- 试验地点
- 6
- 主要终点
- Quality of Life (QOL) - late bowel function as measured by the EPIC questionnaire
研究概览
简要总结
The purpose of this research study is to determine if 5 (five) fractions of external radiotherapy with higher radiation doses per fraction to the pelvis leads to similar results to the standard of care external radiotherapy treatment that is comprised of 25 fractions of external radiotherapy with lower radiation doses per fraction to the pelvis.
This study aims to investigate the impact in quality of life associated with hypofractionated Whole Pelvis Radiotherapy (WPRT) in comparison to conventionally-fractionated WPRT in patients with unfavorable-intermediate and high-risk prostate cancers. This information is valuable as hypofractionated WPRT is a more attractive and convenient treatment approach, and may become the new standard of care if proven to be well-tolerated and effective. Therefore, this study aims to provide a more rational justification for use of hypofractionated WPRT in future larger randomized trials by comparing this strategy with the current standard of care. This study will also provide an initial understanding of the toxicity profile and cancer control associated with hypofractionated WPRT and High Dose Rate Brachytherapy (HDR-BT).
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
- 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
- •Age 18 or older
- •Study Informed Consent provided
- •Pathologically proven diagnosis of prostatic adenocarcinoma
- •Unfavorable intermediate risk [with greater than 15% chance of node involvement based on Memorial Sloan Kettering Cancer Center (MSKCC) nomogram https://www.mskcc.org/nomograms/prostate] or high or very-high-risk prostate cancer based on National Comprehensive Cancer Network (NCCN) classification [Prostatic Specific Antigen (PSA) > 20 ng/mL or clinical cT3a or cT3b or Gleason 8-10]
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •No prior history of pelvic irradiation, brachytherapy, cryosurgery, High-Intensity Focused Ultrasound (HIFU), Transurethral Resection of the Prostate (TURP) or radical prostatectomy
排除标准
- •Presence of nodal or distant metastasis, as confirmed by Magnetic Resonance Imaging (MRI) or Computerized Tomography (CT) of the chest/abdomen/pelvis and bone scan within 45 days of randomization
- •Plan for adjuvant docetaxel post-radiotherapy
- •Serious medical comorbidities or other contraindications to HDR-BT
- •Presence of inflammatory bowel disease
- •Presence of connective tissue disease
- •Medically unfit for general anesthesia
- •Unable or unwilling to complete questionnaires
研究组 & 干预措施
Conventionally-fractionated WPRT
15 Gy HDR brachytherapy boost will be administered followed by 45 Gy WPRT in 25 fractions. Androgen Deprivation Therapy (ADT) may also be prescribed at the discretion of the treating physician.
干预措施: Conventionally-fractionated WPRT (Radiation)
Hypofractionated WPRT
15 Gy HDR brachytherapy boost will be administered followed by 25 Gy WPRT in 5 fractions. Androgen Deprivation Therapy (ADT) may also be prescribed at the discretion of the treating physician.
干预措施: Hypofractionated WPRT (Radiation)
结局指标
主要结局
Quality of Life (QOL) - late bowel function as measured by the EPIC questionnaire
时间窗: I year post treatment (approximately 3 years and 2 months)
Late bowel function as reported by the patient using the standardized questionnaire Expanded Prostate Cancer Index Composite (EPIC) sub-domain approximately 1 year after the end of treatment. The EPIC questionnaire contains 32 questions measuring patient function. Each question has a response option ranging from 0 or 1 (best) to 3, 4, or 5 (worst). The responses then correlate to a scoring scale of 0 to 100, where 0 is the best and 100 is the worst. The values vary from 0 to 100 for each question. The scores can then be added to come up with an overall quality of life score.
次要结局
- Cost Effectiveness of Hypofractionated WPRT(End of study (approximately 7 years and 2 months))
- Biochemical Failure-Free Survival(End of study (approximately 7 years and 2 months))
- Prostatic Specific Antigen (PSA) curve(4 years post treatment (approximately 6 years and 2 months))
- Prostatic Specific Antigen (PSA) Nadir(4 years post treatment (approximately 6 years and 2 months))
- Freedom from Regional Failure(End of study (approximately 7 years and 2 months))
- Androgen Deprivation Therapy Free Survival(End of study (approximately 7 years and 2 months))
- Metastasis Free Survival(End of study (approximately 7 years and 2 months))
- Prostate Cancer Free Survival(End of study (approximately 7 years and 2 months))
- International Prostate Symptom Score (IPSS)(6 weeks post treatment (approximately 2 years and 3 months), 1 year post treatment (approximately 3 years and 2 months) and 2 years post treatment (approximately 4 years and 2 months))
- Quality of Life - acute urinary and sexual QOL as measured by the EPIC questionnaire(6 weeks post treatment (approximately 2 years and 3 months))
- Quality of Life - acute bowel toxicity as measured by the EPIC questionnaire(6 weeks post treatment (approximately 2 years and 3 months))
- Quality of Life - late bowel bother as measured by the EPIC questionnaire(I year post treatment (approximately 3 years and 2 months))
- Overall Survival(End of study (approximately 7 years and 2 months))
- Quality of Life - late urinary and sexual QOL as measured by the EPIC questionnaire(I year post treatment (approximately 3 years and 2 months))
- Toxicity - urinary, bowel, and sexual as measured by CTCAE version 4.0(6 weeks post treatment (approximately 2 years and 3 months), 1 year post treatment (approximately 3 years and 2 months) and 2 years post treatment (approximately 4 years and 2 months))
- Freedom from Local Failure(End of study (approximately 7 years and 2 months))