Evaluation of Tumor Control Based on Serial Multiparametric MRI and Post-Treatment Biopsies For Patients Treated With Dose Intensification to the Dominant Intra-Prostatic Lesion (DIL) Using Ultra-Hypofractionated, MR-Guided Radiotherapy (TUMORNATOR I)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Serious toxicity rate 24 months post-treatment
研究概览
简要总结
The purpose of this study is to assess the impact of this MR-guided radiotherapy on tumor control of the dominant intraprostatic lesion among patients with intermediate risk prostate cancer. This study of Radiotherapy to the Prostate and Dominant Lesion Using Ultra-Hypofractionated, MR-adaptive Radiation Therapy aims to evaluate tumor control after definitive ultra-hypofractionated external beam radiation therapy (including a simultaneously delivered high-dose boost to a dominant lesion as detected on prostate magnetic resonance imaging (MRI)) in patients with intermediate-risk prostate cancer. This will incorporate the use of multiparametric MRI for target segmentation and the use of the MR-linac with adaptive radiation planning to treat the prostate gland, incorporating a dose boost to the dominant intraprostatic lesion (DIL) that is visible on T2-weighted and diffusion-weighted imaging and de-escalation of dose to the remainder of the prostate.
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
- •Intermediate-risk prostate cancer patients will be eligible for this study. Risk groups will be assigned as per National Comprehensive Cancer Network (NCCN) guidelines. Intermediate-risk patients will be defined as:
- •PSA 10-20 ng/ml or
- •Gleason score = 7 or
- •Clinical stage T2b/T2c (T2b: the tumor has spread to more than one-half of one side of the prostate, but not to both sides. T2c: the cancer has invaded both sides of the prostate)
- •Karnofsky Performance Status (KPS) > 80
- •Prostate size < 90 cc
- •Presence of a T2-visible prostatic lesion with maximum dimension of ≥ 0.5 cm and no more than two additional disease foci with a documented Prostate Imaging Reporting and Data System (PIRADS) 4-5 lesion
- •MRI findings: Lesion may contact the capsular edge, possible extracapsular extension (ECE) permitted
- •International Prostate Symptom Score < 18
- •Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form
排除标准
- •Gleason score >7
- •PSA >20 ng/mL
- •Prior or concurrent androgen deprivation therapy for prostate cancer
- •MRI findings: suspicious for/probable ECE
- •MRI findings: >2 disease foci identifiable
- •Evidence of metastatic disease on bone scan or MRI/CT
- •MRI ineligibility due to: the presence of a cardiac pacemaker, defibrillator, or other implanted metallic or electronic device which is considered MR unsafe; severe claustrophobia; inability to lie flat for the duration of the study; etc.
- •Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI
- •Lateral pelvic separation greater than 50 cm and/or anterior-posterior separation greater than 35 cm which are incompatible with MR for Calculating ATtenuation (MRCAT) reconstruction
- •Contra-indications to receiving gadolinium contrast
- •Pelvic or Prostate MRI or CT (MRI preferred) evidence of radiographic T3, T4, or N1 disease
- •Prior history of transurethral resection of the prostate
- •Prior history of urethral stricture
- •Prior history of pelvic irradiation
- •History of inflammatory bowel disease
- •Unable to give informed consent
- •Unable to complete quality of life questionnaires
- •Abnormal complete blood count, including any of the following:
- •Platelet count less than 75,000/ml
- •Hb level less than 10 gm/dl
- •White blood cell (WBC) less than 3.5/ml
- •Abnormal renal function tests (creatinine > 1.5)
研究组 & 干预措施
MRI-guided Intensity Modulated Radiotherapy
All patients will undergo the injection of a hydrogel rectal spacer (SpaceOAR) 1 week before simulation. Patients will undergo ultra-hypofractionated radiation utilizing MR-guided, daily online adaptive planning. Patients will receive 9 Gy/fraction for five fractions for a total dose of 45 Gy to the prostate DIL while the rest of the prostate will be treated to a minimum dose to the rest of the prostate of 30 Gy in five fractions. Radiation will be given every other day, Monday through Friday, until 5 treatments have been completed. Patients will be followed at three and six months after treatment, and every six months thereafter through month 24 (+/- 4 weeks).
干预措施: 1.5 T Elekta Unity MR-Linac system (Radiation)
MRI-guided Intensity Modulated Radiotherapy
All patients will undergo the injection of a hydrogel rectal spacer (SpaceOAR) 1 week before simulation. Patients will undergo ultra-hypofractionated radiation utilizing MR-guided, daily online adaptive planning. Patients will receive 9 Gy/fraction for five fractions for a total dose of 45 Gy to the prostate DIL while the rest of the prostate will be treated to a minimum dose to the rest of the prostate of 30 Gy in five fractions. Radiation will be given every other day, Monday through Friday, until 5 treatments have been completed. Patients will be followed at three and six months after treatment, and every six months thereafter through month 24 (+/- 4 weeks).
干预措施: Hydrogel rectal spacer (SpaceOAR) (Device)
结局指标
主要结局
Serious toxicity rate 24 months post-treatment
时间窗: 24 months post-treatment
Outcome measure will be assessed using NCI CTCAE v5.0 for gastrointestinal and genitourinary toxicity.
Negative biopsy rate 24 months post-treatment
时间窗: 24 months post-treatment
Outcome measure will be assessed via repeat biopsy of the dominant lesion as seen on mp-MRI
次要结局
- Prostate Specific Antigen (PSA) relapse rate at 24 months post-treatment(24 months post-treatment)
- Change in GC Decipher score(Baseline, 24 months post-treatment)
- Proportion of patients with radiation-induced response in the dominant prostatic lesion 6 months post treatment(6 months post-treatment)
- Change in International Prostate Symptom Score (I-PSS)(Baseline, Month 12-18)
- Proportion of patients with radiation-induced response in the dominant prostatic lesion 24 months post treatment(24 months post-treatment)
- Change in genomic classifier (GC) Decipher score(Baseline, 6 months post-treatment)
- Change in International Index of Erectile Function (IIEF) score(Baseline, Month 12-18)
- Change in International Prostate Symptom Score (I-PSS)(Baseline, Month 6)
- Change in International Prostate Symptom Score (I-PSS)(Baseline, Month 3)
- Change in International Index of Erectile Function (IIEF) score(Baseline, Month 3)
- Change in International Index of Erectile Function (IIEF) score(Baseline, Month 6)