NCT05628363进行中（未招募）不适用
Adaptive Stereotactic Body Radiation Therapy to the Prostate and Pelvic Nodes With Simultaneous Integrated Boost to the MR-detected Nodule for Patients With High-risk and Unfavorable Intermediate-risk Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Rate of acute grade ≥3 GI and GU adverse events
研究概览
简要总结
This trial is a prospective clinical trial designed to demonstrate the safety and feasibility of whole-pelvis adaptive prostate stereotactic body radiation therapy (SBRT) with a tumor boost to the magnetic resonance (MR)-detected sites of disease. The hypothesis is that this treatment approach will be safe and feasible with <15% of patients experiencing an acute CTCAEv5 grade ≥3 genitourinary (GU) or gastrointestinal (GI) adverse event.
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 adenocarcinoma of the prostate with NCCN high-risk disease or NCCN unfavorable intermediate-risk disease.
- •Patients with unfavorable intermediate-risk disease must meet the following criteria:
- •At least one intermediate risk factor (IRF):
- •PSA 10-20 ng/mL
- •cT2b-c (AJCC 8th ed.)
- •Gleason score 7
- •At least one "unfavorable" intermediate-risk identifier:
- •Gleason score 4+3
- •≥ 50% of biopsy cores positive
- •NO high-risk features
- •Patients with high-risk disease must meet at least one of the following criteria:
- •PSA > 20
- •Gleason score ≥ 8
- •MRI scan of the prostate with at least one MR-detectable lesion in the prostate/seminal vesicles. PET/CT which is found to display activity n the prostate consistent with prostate cancer may be substituted per investigator discretion.
- •Planning to undergo concurrent whole-pelvis SBRT and androgen deprivation therapy (ADT). ADT may be initiated at any time per institutional standard, so long as ADT begins within 60 days of the start of radiotherapy.
- •At least 18 years of age.
- •ECOG performance status ≤ 1
- •Agreement to adhere to Lifestyle Considerations throughout study duration
- •Able to complete relevant patient-reported quality-of-life questionnaires in the opinion of the treating physician.
- •Able to understand and willing to sign an IRB approved written informed consent document.
排除标准
- •Definitive radiologic evidence of nodal (cN+) or metastatic (cM1) disease on conventional imaging (bone scan) or prostate cancer-specific PET/CT scan (NaF PET/CT, Axumin PET/CT, fluciclovine, choline, or PSMA PET/CT scan). Patients with lymph nodes ≥ 1 cm on short axis are ineligible unless the lymph node is read as benign by Radiology.
- •Prior androgen deprivation therapy. (If the onset of androgen ablation is ≤ 60 days prior to treatment start, the patient is eligible.) Baseline PSA and testosterone must be obtained prior to start of treatment.
- •Systemic chemotherapy within 3 years prior to treatment start.
- •Prior radical prostatectomy, pelvic lymph node dissection, prostate cryotherapy, or high-intensity focused ultrasound (HIFU) to the prostate.
- •Prior pelvic radiotherapy.
- •Presence of baseline CTCAE grade ≥ 2 GI or GU toxicity that does not resolve to grade 1 or less with appropriate intervention.
- •cT4 disease.
- •American Urologic Association (AUA) urinary symptom score ≥ 20
- •Prostate gland measuring >90 cc.
- •Unable to get prostate fiducial markers placed for image guided radiation treatment. Rectal hydrogel is optional and is left to the discretion of the treating physician.
- •Hip prosthetic that does not allow for treatment planning visualization.
- •Prior malignancy (except for non-melanoma skin cancer) unless disease-free for at least 2 years. Patients are not eligible if they have had a prior pelvic malignancy (e.g. bladder cancer, rectal cancer).
- •Prior transurethral resection of the prostate (TURP) within 3 months prior to registration.
- •Uncontrolled intercurrent illness precluding RT and/or ADT including, but not limited to, seizures, myocardial infarction in the past 6 months, current severe or unstable angina pectoris, congestive heart failure requiring hospitalization in the past 6 months, uncontrolled active infection, uncontrolled hypertension, or any condition that in the opinion of the investigator would preclude participation in the study.
- •History of uncontrolled inflammatory bowel disease, including ulcerative colitis and Crohn's disease.
- •Presence of anal fissure or history of bowel or bladder fistula.
- •Scleroderma. Patients who are moderately symptomatic from other autoimmune diseases or patients on biologic therapies for autoimmune diseases are also excluded.
- •Known history of HIV or chronic hepatitis B or C. Testing to evaluate for the presence of HIV and/or hepatitis B or C is not required in patients who do not carry the diagnosis.
- •Poorly visualized bladder and bowel on diagnostic CT or CT simulation (either due to body habitus or artifact).
- •Unable to spend 30 minutes lying on the radiation therapy treatment couch due to significant urinary frequency/urgency or other comorbidities.
研究组 & 干预措施
Adaptive stereotactic body radiotherapy (SBRT)
Experimental
- Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 once or twice weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions.
- Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician.
干预措施: Adaptive stereotactic body radiotherapy (Radiation)
Adaptive stereotactic body radiotherapy (SBRT)
Experimental
- Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 once or twice weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions.
- Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician.
干预措施: Androgen deprivation therapy (Drug)
Adaptive stereotactic body radiotherapy (SBRT)
Experimental
- Treatment consists of adaptive dose-escalated stereotactic body radiotherapy (SBRT) to the pelvic nodes to 25 Gy in 5 once or twice weekly fractions with simultaneous integrated boosts (SIB) to the prostate and proximal seminal vesicles to 36.25 Gy in 5 fractions (full seminal vesicles if involved), to the prostate to 40 Gy in 5 fractions, and to the involved MR-detected nodule(s) to up to 50 Gy in 5 fractions.
- Androgen deprivation therapy (ADT) will be administered to study patients according to institutional standard. Unfavorable Intermediate-risk Disease: Patients should receive a minimum of 4 months of ADT. Patients can receive longer duration of ADT at the discretion of the treating physician. High-risk disease: Patients should receive a minimum of 1 year of ADT. Patients can receive up to 2 years of ADT at the discretion of the treating physician.
干预措施: Ethos Varian treatment system (Device)
结局指标
主要结局
Rate of acute grade ≥3 GI and GU adverse events
时间窗: From start of radiotherapy through 90 days after start of radiotherapy
次要结局
- Changes in patient-reported quality of life as measured by EPIC-26(At screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24)
- Changes in global function as measured by EQ-5D-5L(At screening, end of radiotherapy (week 5), 3 months after start of radiotherapy, and every 3 months until month 24)
- Rate of acute grade ≥3 adverse events at least possibly related to radiotherapy(From start of radiotherapy through 90 days after start of radiotherapy)
- Rate of acute <grade 3 GI and GU adverse events(From start of radiotherapy through 90 days after start of radiotherapy)
- Rate of late grade ≥3 adverse events at least possibly related to radiotherapy(From day 91 after the start of radiotherapy until completion of follow-up at month 60)
研究者
研究点 (2)
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