A Phase II Study to Assess the Feasibility and Activity of Concomitant Radiation and Docetaxel Chemotherapy Followed by Docetaxel Chemotherapy in Prostate Cancer Patients With a Persistent or Rising PSA After Radical Prostatectomy
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel may make tumor cells more sensitive to radiation therapy. Giving docetaxel together with radiation therapy and prednisone after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving docetaxel together with radiation therapy and prednisone works in treating patients who have undergone surgery for prostate cancer.
详细描述
OBJECTIVES:
Primary
- Determine the rate of prostate-specific antigen (PSA) decline and the number of patients reaching a PSA nadir of zero after treatment with chemoradiotherapy comprising docetaxel and external-beam radiotherapy followed by docetaxel and prednisone in patients with hormone-naive prostate cancer who have a persistent or rising PSA after radical prostatectomy.
Secondary
- Determine the tolerability of this regimen in these patients.
- Determine the progression-free survival, based on PSA progression, of these patients.
- Determine the overall survival of patients treated with chemoradiotherapy for rising PSA after radical prostatectomy.
- Determine if the velocity of subsequent PSA failure impacts survival of these patients.
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
- •Histologically confirmed prostate cancer
- •Prostate-specific antigen (PSA) level > 0.2 ng/mL after radical prostatectomy performed ≥ 6 weeks ago
- •No lymph node-positive prostate cancer
- •No documented metastatic disease
- •CT scan of the abdomen and pelvis negative (within the past 6 months)
- •No bone pain OR negative bone scan (within the past 6 months)
- •ECOG performance status 0-2
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9 g/dL
- •Bilirubin normal
- •ALT and AST ≤ 1.5 times upper limit of normal
- •Alkaline phosphatase normal
- •Fertile patients must use effective contraception
- •No peripheral neuropathy > grade 1
- •No other malignancy within the last 5 years that could affect the diagnosis or assessment of prostate cancer
- •No serious illness with a life expectancy of < 5 years
- •No concurrent medical, psychological, or social circumstance that would preclude study compliance
- •No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
排除标准
- •No prior orchiectomy
- •No prior chemotherapy regimen for this disease
- •No prior pelvic radiotherapy
- •No pre- or postoperative androgen manipulation, such as luteinizing hormone-releasing hormone agonists, antiandrogens (flutamide, bicalutamide, or nilutamide), or finasteride
- •Preoperative androgen manipulation for a duration of ≤ 3 months allowed
- •No prior immunotherapy
- •No prior strontium chloride Sr 89, samarium Sm 153 lexidronam pentasodium, or other systemic radioisotopes
- •No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
- •No concurrent herbal or alternative regimens including, but not limited to, any of the following:
- •Saw palmetto
- •Shark cartilage
- •No other concurrent investigational agents
- •No other concurrent chemotherapy, immunotherapy, or hormonal therapy (except for replacement steroids)
研究组 & 干预措施
Docetaxel (Single Arm)
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Prednisone 5mg twice a day Radical prostatectomy as standard of care Radiation therapy will be used as standard of care Post radiation Doxcetaxel
干预措施: docetaxel (Drug)
Docetaxel (Single Arm)
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Prednisone 5mg twice a day Radical prostatectomy as standard of care Radiation therapy will be used as standard of care Post radiation Doxcetaxel
干预措施: prednisone (Drug)
Docetaxel (Single Arm)
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Prednisone 5mg twice a day Radical prostatectomy as standard of care Radiation therapy will be used as standard of care Post radiation Doxcetaxel
干预措施: Radical prostatectomy (Procedure)
Docetaxel (Single Arm)
Docetaxel 20mg/m2/week IV every week during radiation treatment (7 cycles). Prednisone 5mg twice a day Radical prostatectomy as standard of care Radiation therapy will be used as standard of care Post radiation Doxcetaxel
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Rate of Prostate-Specific Antigen (PSA) Decline Reported as the Number of Subjects Reaching a PSA Nadir of Zero Following the Intervention.
时间窗: 5 years
Subjects were followed after the intervention and monitored for PSA (Prostate Specific Antigen) decline for up to 5 years of follow-up, to determine how many had a decline and reached a PSA nadir of zero..
次要结局
- Progression-free Survival Based on PSA Progression(5 years)
- Overall Survival(5 years)
- Correlation Between Velocity of Subsequent PSA Failure and Survival(5 years)