NCT07801664招募中2 期
A Phase II Prospective Trial Utilizing Short Course Androgen Deprivation Therapy In Conjunction With Ultra-Hypofractionated SBRT For High Risk Nccn Prostate Cancer With Lower Risk Artera Scores
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 5-Year Cumulative Incidence of Distant Metastases
研究概览
简要总结
For this study, high risk prostate cancer patients with lower risk ARTERA scores will be treated with 6 months of Androgen Deprivation Therapy (ADT) in conjunction with dose escalated radiotherapy to the prostate and nodes. Specifically, patients enrolled in this study will undergo one of several dose-escalated forms of radiotherapy which would include SBRT with or without a brachytherapy boost.
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
- •Ability to understand and willingness to sign a written informed consent document
- •18 years of age or older male participants
- •Biopsy proven prostate cancer meeting at least one of the following high-risk criteria: Gleason score 8-10 OR; Baseline PSA >20 up to and including 40 ng/ml OR; Patients with Gleason score 6-7 remain eligible if the PSA criterion (>20 ng/mL) is met OR; MRI Radiographic stage T1-T3 disease without evidence of nodal involvement
- •No imaging evidence of nodal metastases on baseline MRI/ CT of the pelvis and PET-PSMA scans
- •Low risk or intermediate risk ARTERA AI scores
- •Serum testosterone ≥ 120 ng/dL determined prior to ADT start
- •At least 4 weeks must have elapsed from major surgery
- •Karnofsky Performance Status (KPS) > 80
- •Prostate size < 90 cc
- •MRI findings: Lesion may have extracapsular extension (ECE)
- •International Prostate Symptom Score (IPSS) < 22
- •Satisfy all MRI screening criteria and be willing to fill out the standard MRI screening form
排除标准
- •Gleason score 6 or 7 in the absence of PSA >20 ng/mL
- •PSA >40 ng/mL
- •Prior or concurrent androgen deprivation therapy for prostate cancer of >3 months duration
- •High Risk ARTERA scores
- •MRI findings: suspicious nodal metastases
- •Evidence of regional lymphadenopathy or metastatic disease on MRI/CT or PSMA PET scan
- •Metallic implant or device in the pelvis that might distort the local magnetic field and compromise quality of mp-MRI
- •Contra-indications to receiving gadolinium contrast
- •KPS < 80
- •Pelvic or Prostate MRI or CT (MRI preferred) evidence of radiographic T4, or N1 disease or bone disease
- •Prior treatment for prostate cancer, including history of chemotherapy or surgery for prostate cancer (except for prior [transurethral resection of prostate] TURP or greenlight [photo selective vaporization of prostate] PVP which would be allowed)
- •History of another malignancy within the previous 2 years except for the following: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, currently in complete remission, or any other cancer that has been in complete remission for at least 3 years. Patients with Crohn's disease or ulcerative colitis
- •IPSS > 22
- •Currently on any ARPis (including but not limited to: enzalutamide, apalutamide, darolutamide, or abiraterone)
- •Prior pharmacologic androgen deprivation therapy (ADT) for prostate cancer is permitted under the following (2) conditions: 1) Participants meeting this criterion will be assigned to a separate stratum within each primary treatment cohort. 2) Patients remain eligible for enrollment provided they have received no more than 3 months of ADT in total, regardless of whether ADT was initiated before screening or registration.
研究组 & 干预措施
High-Risk Prostate Cancer Patients with Lower-Risk ARTERA Scores
Experimental
Patients will be treated with 6 months of Androgen Deprivation Therapy (ADT) in conjunction with dose escalated radiotherapy to the prostate and nodes.
干预措施: Androgen Deprivation Therapy (ADT) (Drug)
High-Risk Prostate Cancer Patients with Lower-Risk ARTERA Scores
Experimental
Patients will be treated with 6 months of Androgen Deprivation Therapy (ADT) in conjunction with dose escalated radiotherapy to the prostate and nodes.
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
5-Year Cumulative Incidence of Distant Metastases
时间窗: Up to Year 5
Incidence of distant metastases (DM). DM is defined as the first occurrence of radiographic or biopsy-confirmed distant metastatic disease.
次要结局
- Time to Biochemical Failure(Up to Year 5)
- Overall Survival (OS)(Up to Year 5)
- Distant Metastasis-Free Survival (DMFS)(Up to Year 5)
- Change in Expanded Prostate Cancer Index Composite-26 (EPIC-26) Score(Baseline, Year 2)
- Change in International Prostate Symptom Score (IPSS) Score(Baseline, Year 2)
- Change in Short-Form-12 (SF-12) Score(Baseline, Year 2)
研究者
研究点 (1)
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