Phase II Trial of Short Course Androgen Deprivation, Hypofractionated Pelvic Radiation and a Brachytherapy Boost for NCCN High-Risk Prostate Cancer With Low-Intermediate Risk Decipher Genomic Score
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 7
- 主要终点
- Distant metastatic disease-free (DMF) rate
研究概览
简要总结
The purpose of this study is to find out whether combining a shorter than standard course of ADT with standard prostate brachytherapy and hypofractionated external beam radiation therapy is a safe and effective way to prevent high-risk prostate cancer from coming back and/or spreading to other parts of the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Pathologically-proven diagnosis of prostate adenocarcinoma
- •Clinical stage T3-4 or Gleason score 8-10 or PSA >20 ng/ml
- •°If radiographic T3-T4 is the only high-risk factor, it must be "consistent with" or >90% probability of having T3-T4 disease determined by the reading radiologist.
- •Decipher genomic score ≤0.6
- •Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)
- •KPS ≥70 or ECOG 0-2
- •Estimated life expectancy >5 years
- •Baseline prostate volume ≤90 cc
- •Baseline IPSS ≤20
- •No contraindications to ADT, brachytherapy, or pelvic external beam radiation therapy as determined by the treating radiation oncologist per standard practice
- •Patients who have already started ADT consisting of bicalutamide 50 mg PO daily with leuprolide or an equivalent GnRH analogue are eligible if given for ≤ 60 days prior to registration
排除标准
- •Regional lymph node or metastatic disease
- •Prior pelvic radiation
- •Prior prostate surgery (including TURP or cryosurgery)
- •Prior history of inflammatory bowel disease
- •Unable to undergo anesthesia or brachytherapy
- •Active second malignancy or past history of malignancies diagnosed within the last 2 years that requires active therapy and/or in remission, with the exception of resected non-melanoma skin cancers, non-muscle invasive bladder cancer, stage I head and neck cancer, or stage I colorectal cancer
研究组 & 干预措施
Hormone Therapy and Radiation
Patients enrolled in this study will receive ADT for 6 months which will consist of bicalutamide 50 mg PO daily starting approximately 1-2 weeks before leuprolide 22.5mg injected every 3 months. The HDR prostate brachytherapy procedure will be performed approximately 3 months after starting ADT to allow for potential radiosensitization and cytoreduction. Approximately 4 weeks after the HDR boost, patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.
干预措施: Androgen deprivation therapy (ADT) (Biological)
Hormone Therapy and Radiation
Patients enrolled in this study will receive ADT for 6 months which will consist of bicalutamide 50 mg PO daily starting approximately 1-2 weeks before leuprolide 22.5mg injected every 3 months. The HDR prostate brachytherapy procedure will be performed approximately 3 months after starting ADT to allow for potential radiosensitization and cytoreduction. Approximately 4 weeks after the HDR boost, patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.
干预措施: Brachytherapy (Radiation)
Hormone Therapy and Radiation
Patients enrolled in this study will receive ADT for 6 months which will consist of bicalutamide 50 mg PO daily starting approximately 1-2 weeks before leuprolide 22.5mg injected every 3 months. The HDR prostate brachytherapy procedure will be performed approximately 3 months after starting ADT to allow for potential radiosensitization and cytoreduction. Approximately 4 weeks after the HDR boost, patients will receive image-guided, intensity-modulated, hypofractionated radiation therapy targeting the prostate, seminal vesicles and pelvic lymph nodes to a dose of 25 Gy in 5 fractions delivered daily.
干预措施: Hypofractionated pelvic External beam radiation (Radiation)
结局指标
主要结局
Distant metastatic disease-free (DMF) rate
时间窗: 3 years
Time to distant metastases will be estimated from the date of enrollment until distant metastases
次要结局
- Overall survival rate(3 years)
- Pathological response rate(Between 24-36 months after radiation)
- Cumulative incidence of biochemical failure(3 years)
- Acute and late physician-scored toxicity(3 years)