Outcomes Following Intensity Modulated Radiation Therapy With And Without Erectile Tissue Dose Sparing For Favorable To Intermediate Risk Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Erectile Dysfunction Rates
研究概览
简要总结
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) may reduce damage to healthy tissue near the tumor. It is not yet known whether reducing the dose of radiation to erectile tissue will help prevent erectile dysfunction.
PURPOSE: This randomized phase III trial is studying intensity-modulated radiation therapy alone to see how well it works compared to intensity-modulated radiation therapy with reduced doses to erectile tissue in treating patients with stage II prostate cancer.
详细描述
OBJECTIVES:
Primary
- Compare erectile dysfunction in patients with stage T1b-T2c adenocarcinoma of the prostate after treatment with intensity-modulated radiotherapy with vs without dose sparing for erectile tissue.
Secondary
- Compare biochemical freedom from failure rates, as a measure of prostate cancer control, in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Determine the association of molecular markers and biochemical freedom from failure rate and other endpoints in patients treated with these regimens.
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
- Single (Participant)
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Clinical stage T1b-T2c by palpation
- •Pretreatment prostate-specific antigen ≤ 20 ng/mL
- •Gleason score ≤ 7
- •Suitable erectile function, defined as a response ≥ score 2 in question #1 of the International Index of Erectile Function Questionnaire
- •No clinical, radiographic, or pathologic evidence of nodal or distant metastatic disease
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status
- •Zubrod 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Fertile patients must use effective contraception
- •No other active malignancy within the past 5 years except nonmetastatic skin cancer or early-stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma)
- •No other medical condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Prior androgen-ablation therapy allowed provided total calculated duration ≤ 4 months
- •Radiotherapy
- •No prior pelvic radiotherapy
- •No prior or planned radical prostate surgery
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients undergo conventional intensity-modulated radiotherapy (IMRT) once daily 5 days a week for approximately 7.5 weeks.
干预措施: radiation therapy (Radiation)
Arm II
Patients undergo IMRT with dose restriction to erectile tissue once daily 5 days a week for approximately 7.5 weeks.
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Erectile Dysfunction Rates
时间窗: 5 year duration after completion of radiotherapy
Postage Stamp Test -A row of stamps is placed around the base of the penis and the ends are moistened and joined. If the circle is broken in the morning then the subject was recorded as having had a nocturnal erection International Index of Erectile Function (IIEF) Questionnaire * 15-item questionnaire that measures erectile function * Includes companion questionnaire which measures how the partner feels her sexual relationship with the patient has changed since his cancer diagnosis and therapy
次要结局
- Acute GU Toxicity(5 years after treatment)
- Acute GI Toxicity(5 years after treatment)
- Percentage of Patients With Freedom From Biochemical Failure(2 years after treatment)