A Phase II Randomized Trial of MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- PSA Response Rate
研究概览
简要总结
- The investigators hypothesize that increasing radiation dose to the functional MRI-defined lesion in the prostate bed will result in an improved initial complete response (reduction in prostate-specific antigen (PSA) to < 0.1 ng/mL), which is related to long-term outcome biochemically.
- Biomarker expression levels differ in the DCE-MRI enhancing and non-enhancing tumor regions (when applicable).
- 10-15% of men undergoing RT have free circulating DNA (fcDNA) or tumor cells (CTC) that are related to an adverse treatment outcome.
- Prostate cancer-related anxiety will be reduced in the MRI targeted SRT arm, because the patients will be aware that the dominant tumor will be targeted with higher radiation dose (compared to those pts who were treated on standard arm prior to its closure).
详细描述
Phase 3 arms I (SSRT) and II (MTSRT) were closed. Study recruitment was suspended until re-opening as a single-arm Phase 2 (MTSRT) study.
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
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer patients with a PSA after prostatectomy of at least 0.1 ng/mL and up to 4.0 ng/mL within 3 months prior to enrollment.
- •Patients with or without palpable abnormalities on digital rectal exam (DRE) are eligible.
- •Minimum of 3 months since prostatectomy to allow for return of urinary continence and healing.
- •Imaging detectable lesion or lesions in prostate bed or regional lymph node (LN). Each lesion should be at least 0.4 cc and a maximum of 6 cc and was obtained ≤ 3 months prior to protocol entry or enrollment.
- •No evidence of metastatic (distant) disease (pelvic nodes are allowed up to common iliac).
- •Negative bone scan if deemed necessary by treating physician obtained ≤ 4 months prior to protocol entry or enrollment.
- •No previous pelvic radiotherapy.
- •Serum total testosterone taken within 3 months prior to enrollment.
- •No concurrent, active malignancy, other than nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic lymphoma). If a prior malignancy is in remission for ≥ 3 years then the patient is eligible.
- •Ability to understand and the willingness to sign a written informed consent document.
- •Zubrod performance status <
- •Patients must agree to fill out quality of life/psychosocial questionnaires.
- •Age ≥ 35 and ≤ 85 years.
排除标准
- •a. Prior androgen deprivation therapy is not permitted if it was within 6 months previous to signing consent form. (NOTE: Therapy given as part of the planned course of radiation is allowed).
研究组 & 干预措施
Phase 3 - Arm I: Standard Salvage Radiation Treatment (SSRT)
Phase 3 total dose of 68 Gy will be delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes.
this arm is closed
干预措施: Standard Salvage Radiation Treatment (SSRT) (Radiation)
Phase 3 - Arm II: Mapped Tumor Salvage RT (MTSRT)
Phase 3 Patients will receive the same treatment to the CTV of 68 Gy in 34 fractions and the Gross Tumor Volume (GTV) defined by functional imaging will receive 2.25 Gy per day for a total of 76.5 Gy (biological equivalent to 80 Gy in 2.0 Gy fractions assuming an α/β ratio of 3).
this arm was continues as single arm phase 2
干预措施: Mapped Tumor Salvage RT (MTSRT) (Radiation)
Phase 2: Mapped Tumor Salvage RT (MTSRT)
Phase 2 Patients will receive the same treatment to the CTV of 68 Gy in 34 fractions and the Gross Tumor Volume (GTV) defined by functional imaging will receive 2.25 Gy per day for a total of 76.5 Gy (biological equivalent to 80 Gy in 2.0 Gy fractions assuming an α/β ratio of 3).
干预措施: Mapped Tumor Salvage RT (MTSRT) (Radiation)
结局指标
主要结局
PSA Response Rate
时间窗: Up to 23 months
Prostate-Specific Antigen (PSA) response rate is defined as the percentage of study patients with PSA less than 0.1 ng/mL at 21 months after completion of study treatment.
次要结局
- Measurement of Tissue Biomarker Expression(Up to 65 months)
- Incidence and Relationship of Circulating DNA and Tumor Cells to Tissue Biomarkers(Up to 65 months)
- Overall Survival (OS)(Up to 65 months)
- Health-Related Quality of Life Scores: MAX-PC(Up to 65 months)
- Health-Related Quality of Life Scores: EPIC SF-12(Up to 65 months)
- Incidence of Treatment-Emergent Toxicity(Up to 8 months)
- Health-Related Quality of Life Scores: IPSS(Up to 65 months)
- Biochemical and Clinical Failure(Up to 65 months)
- Failure-free Survival (FFS)(Up to 65 months)
研究者
Matthew Abramowitz, MD
Assistant Professor of Clinical
University of Miami