A Phase II Study of Decipher-Guided Dose Escalated Radiation Therapy In Unfavorable Intermediate Risk Prostate Cancer Patients Treated SBRT Alone Without Androgen Deprivation Therapy
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 222
- 试验地点
- 13
- 主要终点
- Rate of biochemical progression free survival
研究概览
简要总结
The researchers are doing this study to find out if stereotactic body radiation therapy (SBRT) without androgen deprivation therapy (ADT) is an effective treatment approach for people with unfavorable intermediate-risk prostate. The researchers will see whether SBRT can prevent participants' cancer from coming back and/or spreading to other parts of the body. In addition, they will look closely at how safe and effective it is to rely on Decipher test results for determining which patients would benefit from more extensive radiation 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
- •Pathologically proven diagnosis of prostate adenocarcinoma within 12 months of enrollment
- •Unfavorable intermediate risk prostate cancer by NCCN 2021 risk stratification guidelines, including any of the following clinicopathologic features:
- •Gleason Score 4+3
- •≥ 50% biopsy cores positive
- •Two or more of the following risk factors:
- •Grade Group 2 or 3
- •PSA 10 - 20 ng/mL
- •Able to undergo MRI for initial staging and MR based radiation planning
- •Sufficient biopsy tissue available for Decipher genomic testing
- •Prostate volume < 90cc
- •IPSS ≤ 20
- •KPS ≥ or ECOG 0-2
- •Estimated life expectancy >5 years
- •Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization)
排除标准
- •Radiographic T3-T4 detected on staging mpMRI
- •°Must be "consistent with" (>90% probability) or suspicious for/probable/probably (75%-90% probability) ofT3-T4 disease determined by the reading radiologist.
- •Evidence of distant metastases as determined by MRI, PET, or CT imaging
- •Evidence of pelvic lymph node involvement as determined by MRI, PET, or CT imaging
- •Prior treatment for prostate cancer including chemotherapy, surgery, or hormonal therapy
- •Prior pelvic radiation
- •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
- •TURP or greenlight PVP within 6 months of enrollment
- •History of Crohn's Disease or Ulcerative Colitis
研究组 & 干预措施
Patients with low-intermediate risk Decipher scores
Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions).
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
Patients with high risk Decipher scores
Will receive ultrahypofractionated EBRT to the prostate and seminal vesicles (40Gy in 5 fractions) with a boost of up to 45Gy to the dominant intraprostatic lesion as identified on pretreatment MRI plus hypofractionated pelvic EBRT (25Gy in 5 fractions).
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Radiation)
结局指标
主要结局
Rate of biochemical progression free survival
时间窗: 2 years
Biochemical progression will be determined according to the established criteria of 2 ng/nl elevation of the PSA nadir level (nadir + 2 definition).
次要结局
未报告次要终点