Local Cytoreductive Treatments for Men With Newly Diagnosed Metastatic Prostate Cancer in Addition to Standard of Care Treatment
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 433
- 试验地点
- 33
- 主要终点
- Safety (Adverse Events)
研究概览
简要总结
Local cytoreductive treatments for men with newly diagnosed metastatic prostate cancer in addition to standard of care treatment
详细描述
TITLE: Additional Treatments to the Local tumour for metastatic prostate cancer: Assessment of Novel Treatment Algorithms (ATLANTA)
OBJECTIVES: To determine whether the addition of local treatment to the prostate (minimally invasive therapy or radical therapy [prostatectomy or radiotherapy]), including selective metastases-directed therapy, improves oncological outcomes in men receiving standard of care treatment for newly diagnosed metastatic prostate cancer
PHASE: Phase II Randomised Control Trial (RCT) incorporating an internal pilot
DESIGN: Three-arm unblinded randomised controlled trial using a positive control
SAMPLE SIZE: 432
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Diagnosed with prostate cancer within 6 months of screening visit
- •Metastatic disease (Any T, Any N, M1+) of any grade, stage or Prostate Specific Antigen (PSA) level.
- •Fit to undergo standard of care treatment for metastatic disease and both minimally invasive therapy and prostate radiotherapy/prostatectomy.
- •Performance status 0-2
- •Histologically proven local tumour
排除标准
- •Patient did not undergo and/or is unable to undergo standard of care baseline imaging tests for confirmation of metastatic status (CT abdomen/pelvis AND chest Xray (or CT chest) AND radioisotope bone scan (or whole body imaging such as MRI or PET imaging as alternative to all preceding scans mentioned here) AND prostate MRI.
- •Prior exposure to long-term androgen deprivation therapy or hormonal therapy for the treatment of prostate cancer unless started within 6 months of screening visit.
- •Prior chemotherapy or local or systemic therapy for treatment of prostate cancer (apart from ADT or hormonal therapy as outlined above)
结局指标
主要结局
Safety (Adverse Events)
时间窗: 2-4 years (continuous)
Safety (Adverse Events), measured using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Grade 1-5.
Prostate cancer on post-standard of care prostate biopsy.
时间窗: 6 months
Proportion of patients with complete pathological response, measured on post SOC (systemic therapy) prostate biopsies (Internal Pilot).
Progression-free survival (PFS)
时间窗: 2-4 years
Progression-free survival (PFS), measured as a composite outcome of Biochemical failure (PSA progression value) or Local progression or Lymph node progression or Bone metastases progression (new sites) or Progression or development of new distant metastases, defined as lymph nodes outside the pelvis, bone or organ involvement or Skeletal-related events confirmed as progression as in the Systemic Therapy in Advancing Or Metastatic Prostate Cancer: Evaluation Of Drug Efficacy (STAMPEDE) RCT).
次要结局
- Rectal side effects(Baseline, week 26, 52, then at 24 months.)
- Health-related quality-of-life(Baseline, week 26, 52, then at 24 months.)
- Progression (Biochemical / Radiological / Clinical)(Baseline, week 12, 26, 34, 52 then every every 24 weeks for remaining years 2 to 4 and Imaging tests at baseline and if progression is suspected by a clinician)
- Sexual side effects(Baseline, week 26, 52, then at 24 months.)
- Urinary side effects(Baseline, week 26, 52, then at 24 months.)