A Phase I/II Dose-escalation Study Evaluating the Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy
概览
- 阶段
- 1 期
- 干预措施
- HDR brachytherapy
- 疾病 / 适应症
- Prostate Cancer
- 发起方
- Washington University School of Medicine
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Biochemical control experienced by patients with prostate cancer treated with an HDR implant
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy.
研究者
入排标准
入选标准
- •Histologically or cytologically confirmed diagnosis of early stage prostate cancer.
- •Must be considered either low-risk (T1-T2a, Gleason ≤ 6, PSA \< 10 ng/mL) or favorable intermediate-risk (Gleason 3 +4 = 7, percentage of positive biopsy cores \< 50%, no more than one NCCN intermediate risk factor).
- •Prior androgen deprivation therapy is allowed and may have been initiated up to 6 months prior to the date of the HDR implant. The complete duration of androgen deprivation therapy can range from 4 months to 36 months provided it has been initiated no more than 6 months prior to the date of the HDR implant.
- •At least 18 years of age.
- •ECOG performance status ≤ 2
- •Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
排除标准
- •Prior radiation therapy to the prostate or lower pelvis encompassing the prostate.
- •A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only.
- •Currently receiving any other investigational agents.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- •Unable to undergo general, spinal or local anesthesia.
- •Prior TURP with a sufficiently large defect that would compromise the integrity of the implant per clinician's assessment.
研究组 & 干预措施
HDR brachytherapy - 21 Gy
-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 21 Gy.
干预措施: HDR brachytherapy
HDR brachytherapy - 23 Gy
-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 23 Gy.
干预措施: HDR brachytherapy
HDR brachytherapy - 25 Gy
-All patients will be treated with a single implant and single HDR fraction. Treatment will be delivered within a single 24-hour period measured from the beginning of the implant procedure. All patients will receive a dose of 25 Gy.
干预措施: HDR brachytherapy
结局指标
主要结局
Biochemical control experienced by patients with prostate cancer treated with an HDR implant
时间窗: Through 3 years after implant
-Response will be determined by PSA. The Phoenix definition will be used for determining biochemical failure: a rise of 2 ng/mL or more above the PSA nadir
次要结局
- Rate of acute toxicity experienced by patients with prostate cancer treated with an HDR implant(From start of treatment through 90 days)
- Rate of late toxicity experienced by patients with prostate cancer treated with an HDR implant(From day 91 through 3 years after implant)