Stereotactic Body Radiation Therapy and Short-Term Androgen Ablation for Intermediate-Risk, Localized, Adenocarcinoma of the Prostate
概览
- 阶段
- 1 期
- 干预措施
- Radiation Therapy
- 疾病 / 适应症
- Adenocarcinoma of the Prostate
- 发起方
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Biochemical Failure Free-rate (BFFR) Associated With the Combined Hypofractionated Dose Regimen and Androgen Deprivation Therapy (ADT).
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
A study to see how effective and tolerable radiation therapy along with androgen deprivation therapy is in treating prostate cancer.
详细描述
This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total.
研究者
入排标准
入选标准
- •Histologically confirmed, locally confined adenocarcinoma of the prostate
- •Patient must fit D'Amico intermediate risk criteria by clinical stage (T2b-T2c), PSA (prostatic specific antigen) (10-20 ng/mL), and/or Gleason score (Gleason 7).
- •The patient has decided to undergo external beam radiation as treatment choice for his prostate cancer.
- •Signed study-specific consent form prior to registration
排除标准
- •Stage T3-4 disease.
- •Gleason 8 or higher score.
- •PSA \> 20 ng/ml.
- •IPSS (International Prostate Symptom Score) \> 15
- •Clinical or Pathological Lymph node involvement (N1).
- •Evidence of distant metastases (M1).
- •Radical surgery for carcinoma of the prostate.
- •Previous Chemotherapy, unless intervention was greater than 5 years from beginning treatment for current prostate cancer.
- •Previous pelvic radiation therapy.
- •Previous or concurrent cancers other than basal or squamous cell skin cancers or superficial bladder cancer unless disease free for at least 5 years.
研究组 & 干预措施
Radiation with Androgen Deprivation Therapy (ADT)
This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens.
干预措施: Radiation Therapy
Radiation with Androgen Deprivation Therapy (ADT)
This will be a Phase I/II study evaluating the effectiveness and toxicity of a combined regimen of 7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions) with androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT (stereotactic body radiation therapy). This choice of daily dose is based on the prior published experience showing safety and efficacy of hypofractionated regimens.
干预措施: Androgen Deprivation Therapy (ADT)
结局指标
主要结局
Biochemical Failure Free-rate (BFFR) Associated With the Combined Hypofractionated Dose Regimen and Androgen Deprivation Therapy (ADT).
时间窗: From consent up to 5 years post treatment completion
To assess 5-year biochemical failure free rate (BFFR) associated with image-guided radiation therapy in doses of 7.25 Gy every other day to a total dose of 36.25 Gy (5 fractions) along with 4 months of androgen deprivation therapy (ADT) neoadjuvantly and concurrently. BFFR is defined as binary indicator whether PSA has increased by 2 ng/ml or more above the nadir PSA any time before the end of 5 years as the number of events.
次要结局
- Toxicity as Assessed as Incidence of Grade 3 or Greater Gastrointestinal (GI) and Genitourinary (GU) Adverse Events(Consent to up to 5 years of follow-up or biochemical failure.)
- Overall Survival Rate(Start of treatment up to 5 years)
- Number of Patients Who Completed Blood Collection of Whole Blood for Future Research(Up to 2 years post treatment)
- Self-reported Patient Quality of Life Data Using the International Prostate Symptom Score (IPSS).(Measured at baseline and at 3, 12, 24 and 36 months post treatment)
- Patient Reported Sexual Health Inventory for Men (SHIM), a Self-reported Quality of Life Assessment(Baseline and at 3,12, 24 and 36 months follow-up)
- The Expanded Prostate Cancer Index Composite 26 (EPIC). Self-reported Quality of Life Assessment of Sexual Health(3,12, 24 and 36 months follow-up)