A Randomized Phase-II Pilot Trial of Docetaxel and Prednisone Versus Radiation Therapy Plus Docetaxel and Prednisone in Patients With Nonmetastatic and Oligometastatic Castrate Resistant Prostate Cancer
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Estimation of progression free survival(PFS) and response rate
研究概览
简要总结
The main purpose of this study is to find out whether adding radiation therapy to the standard treatment of chemotherapy for prostate cancer is tolerated well and is more effective than the standard treatment of chemotherapy alone
详细描述
Most physicians would consider chemotherapy to be the standard for prostate cancer. In this study all participants will receive the standard chemotherapy. In addition, half the participants will also receive radiation therapy. It is hoped that the radiation therapy will provide additional benefit. The use of radiation therapy and chemotherapy for patients with this kind of cancer is not considered standard treatment at the present time.
Participants will be randomized into groups (or Arms) by a computer program. Participants randomized to Arm 1 will receive chemotherapy alone. Participants in Arm 2 will receive chemotherapy and radiation therapy. Participants in both groups (Arm 1 and Arm 2) will receive standard chemotherapy with docetaxel and prednisone. Docetaxel is given through a needle in a vein in the arm every 3 weeks or 21 days. Participants will take a prednisone tablet once per day until 21 days after the last dose of docetaxel. In addition, all participants will be given a drug called dexamethasone twice daily for 6 doses to help with the side effects of docetaxel. Participants in Arm 2 will first receive radiation therapy to the pelvis and prostate gland. Radiation therapy will be delivered once a day, five days a week for a total of 8-9 weeks. Then beginning 4-6 weeks after the end of radiation therapy, chemotherapy will be given, as described above. In both Arms, the total number of cycles of docetaxel and prednisone will depend upon how the tumor responds to these drugs. All patients should receive a minimum of three cycles of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Participants must have a diagnosis of castrate resistant prostate cancer.
- •Participants must be 18 years old or older.
- •Biopsy of tissue from the prostate or enlarged lymph nodes may be required.
- •Patients must sign study specific informed consent prior to study entry.
- •Men of child-producing potential must be willing to consent to use effective contraception while on treatment and for at least 3 months afterwards.
排除标准
- •Participants cannot have prior chemotherapy for prostate cancer.
- •Participants cannot have prior radiation therapy to the pelvis.
研究组 & 干预措施
Chemotherapy alone, no radiation therapy
A) Docetaxel: 75 mg/m2 IV infusion over 1 hour on day 1 of each cycle every 21 days
B) Prednisone: 10 mg orally for 21 days after each dose of docetaxel
干预措施: Docetaxel and Prednisone (Drug)
Chemotherapy with Radiation Therapy
A) Docetaxel: 75 mg/m2 IV infusion over 1 hour on day 1 of each cycle every 21 days B) Prednisone: 10 mg orally for 21 days after each dose of docetaxel
GROUPS 1 and 2 Whole Pelvis (45 Gy) + Prostate boost (20-25 Gy) in 1.8 Gy fractions, 5 fractions/week.
GROUPS 2 Bone metastasis (bone scan index < 1.4%): 30 Gy in 10 fractions or 35 Gy in 12 fractions.
GROUPS 1,2 Abdominal Nodes (IF POSITIVE ON CT/MRI SCAN): 45-50 Gy in 1.8 Gy fractions, 5 fractions/week.
干预措施: Docetaxel and Prednisone (Drug)
Chemotherapy with Radiation Therapy
A) Docetaxel: 75 mg/m2 IV infusion over 1 hour on day 1 of each cycle every 21 days B) Prednisone: 10 mg orally for 21 days after each dose of docetaxel
GROUPS 1 and 2 Whole Pelvis (45 Gy) + Prostate boost (20-25 Gy) in 1.8 Gy fractions, 5 fractions/week.
GROUPS 2 Bone metastasis (bone scan index < 1.4%): 30 Gy in 10 fractions or 35 Gy in 12 fractions.
GROUPS 1,2 Abdominal Nodes (IF POSITIVE ON CT/MRI SCAN): 45-50 Gy in 1.8 Gy fractions, 5 fractions/week.
干预措施: Radiation Therapy (Drug)
结局指标
主要结局
Estimation of progression free survival(PFS) and response rate
时间窗: Day one of each treatment cycle. cycles are every 21 days and at the end of post-treatment
The primary objective is to estimate the progression free survival (PFS) and treatment response of patients with non-metastatic or oligometastatic CRPC in the two study arms of either chemotherapy alone (ARM 1) or a combination of RT and chemotherapy (ARM 2).
次要结局
- Overall survival of patients(at study completion and during follow-up (At least every 3 months (12 weeks) until evidence of progression or relapse for a maximum of 2 years, subsequently every 4 months for 2 years, then every 6 months for 2 years from the time of registration))
- Estimation of treatment-related toxicity(Every 21 days. weekly radiation therapy, Follow-up is every 3 mo until evidence of progression or relapse for 2 years, then every 4 mo for 2 years, then every 6 mo for 2 years from the time of registration)
- Measure of prostate antigen-specific immune response(Every 21 days during treatment. Follow-up is every 3 mo until evidence of progression or relapse for 2 years, then every 4 mo for 2 years, then every 6 mo for 2 years from the time of registration))
- Multiple gene profiles will be analyzed.(At Study Completion)