A Phase II Prospective 2-Arm Cohort Interventional Trial Utilizing Ultra-Hypofractionated SBRT With or Without Short Course Androgen Deprivation Therapy For Unfavorable Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 392
- 试验地点
- 1
- 主要终点
- Disease-Free Survival
研究概览
简要总结
For this study, unfavorable intermediate risk prostate cancer patients will select whether they are to be treated with the standard of care (SOC) 6 months of Androgen Deprivation Therapy (ADT) in conjunction with stereotactic body radiation therapy/radiosurgery (SBRT) directed to the prostate versus SBRT alone. The patient population will include those with National Comprehensive Cancer Network (NCCN)-defined unfavorable intermediate risk disease. All patients will be followed every 6 months for up to 5 years from the first patient treated and will undergo a routine 24-30 months post-SBRT prostate biopsy to assess for local tumor control.
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
- •Biopsy proven unfavorable intermediate risk prostate cancer, which includes patients with any one of the following variables: Gleason 4+3 disease; Percent positive cores > 50% of Gleason 7 disease; 2-3 intermediate risk factors (Gleason 7; PSA 10-20 ng/mL; or T2b-T2c)
- •Patients must have tissue available for Decipher score testing. Results must be available before start of treatment.
- •Serum testosterone ≥ 150 ng/dL determined within 2 months prior to enrollment
- •At least 4 weeks must have elapsed from major surgery
- •Karnofsky Performance Scale (KPS) ≥ 80%
- •Prostate size as determined on MRI to be < 90 cc. Prostate size can be determined on CT scan if MRI is not available
- •IPSS ≤ 20
- •Patient must be available for follow-up. After 2 years of follow-up, upon completion of post-treatment biopsy, telephone and chart review-based follow-up will be acceptable
- •Adequate hepatic function with serum bilirubin less than or equal to 1.5 times the upper institutional limits of normal (ULN), Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) less than or equal to 2.5 x ULN. Patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is < 3 mg/dL with a predominance of indirect bilirubin
- •Adequate renal function with serum creatinine less than or equal to 1.5 x ULN
- •Adequate hematologic function with absolute neutrophil counts of at least 1,500 cell/mm3 and platelets of at least 100,000 cells/mm3 and hemoglobin value > 9 g/dL (Note: patients whose anemia has been corrected to a hemoglobin value > 9 g/dL with blood transfusions are allowed).
排除标准
- •CT or MRI or Positron Emission Tomography (PET) scan evidence of metastatic disease to the bone
- •Patients with one or more positive lymph nodes considered suspicious as determined by clinical assessment on MRI or CT or PET scan
- •Prior treatment for prostate cancer, including history of chemotherapy, hormonal therapy within 30 days of enrollment or surgery for prostate cancer (except for prior (transurethral resection of prostate) TURP or greenlight (photoselective 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
研究组 & 干预措施
ADT with SBRT
The ADT patients will be treated with monthly Degarelix, or Leuprolide injections or daily Relugolix pills. After three months have elapsed, these patients as per routine will undergo SBRT. SBRT comprises stereotactic, ultra-fractionated radiotherapy every other day for five total treatments.
干预措施: Leuprolide, Degarelix or Relugolix (Drug)
ADT with SBRT
The ADT patients will be treated with monthly Degarelix, or Leuprolide injections or daily Relugolix pills. After three months have elapsed, these patients as per routine will undergo SBRT. SBRT comprises stereotactic, ultra-fractionated radiotherapy every other day for five total treatments.
干预措施: Stereotactic body radiation therapy/radiosurgery (SBRT) (Radiation)
SBRT Alone
Participants treated with SBRT alone (standard of care) will be administered stereotactic, ultra-fractionated radiotherapy every other day for five total treatments.
干预措施: Stereotactic body radiation therapy/radiosurgery (SBRT) (Radiation)
结局指标
主要结局
Disease-Free Survival
时间窗: Up to Year 5
Defined as the percentage of participants who survive without any signs or symptoms of prostate cancer.
次要结局
- Incidence of Biochemical Failure(Up to Year 5)
- Incidence of Distant Metastases(Up to Year 5)
- Overall Survival(Up to Year 5)
- Number of Positive Post-Treatment Biopsies(Year 2 Post-Treatment (Month 24-30))
- Change in Expanded Prostate Cancer Index Composite (EPIC) Questionnaire Score (EPIC-26)(Baseline, Year 2)
- Change in International Prostatism Symptom Score (IPSS)(Baseline, Year 2)
- Change in 12-Item Short Form Health Survey (SF-12) Score(Baseline, Year 2)