Phase I Study of Hyperthermia Combined With High Dose Rate Salvage Radiotherapy for the Treatment of Radiation Recurrent Prostate Cancer
概览
- 阶段
- 不适用
- 干预措施
- High-Dose Rate Brachytherapy
- 疾病 / 适应症
- Recurrent Prostate Carcinoma
- 发起方
- Sidney Kimmel Cancer Center at Thomas Jefferson University
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Incidence of dose limiting toxicity defined as >= grade 3 per National Cancer Institute Common Toxicity Criteria version 4 occurring within 90 days of treatment and at least possibly attributed to radiation therapy and/or hyperthermia
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
This phase I trial studies the side effects and best way to give hyperthermia and high dose rate radiation therapy in treating patients with prostate cancer that has come back after prior radiation treatment. Radiation therapy, such as high dose rate brachytherapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. Hyperthermia therapy may make tumor cells more sensitive to the effects of radiation therapy by heating them to several degrees above normal body temperature. Giving hyperthermia and high dose rate radiation therapy may work better in treating patients with recurrent prostate cancer after radiation.
详细描述
PRIMARY OBJECTIVES: I. To assess the safety and feasibility of combined single fraction high dose rate (HDR) brachytherapy followed immediately by interstitial hyperthermia treatment of radio-recurrent prostate cancer. SECONDARY OBJECTIVES: I. To assess long-term toxicity. II. To provide a preliminary assessment of efficacy. III. To obtain blood for future analysis of immune response to combined radiation therapy and hyperthermia. OUTLINE: Patients undergo high dose rate brachytherapy for 15-30 minutes. Immediately after radiation therapy (no longer than 90 minutes), patients undergo interstitial hyperthermia treatment for up to 60 minutes. After completion of study treatment, patients are followed up at 1 week, 1 month, and every 3 months for 2 years, every 6 months for 3 years and annually thereafter.
研究者
入排标准
入选标准
- •Male age \>= 18 years
- •Karnofsky performance status \> 70%
- •Expected survival of at least 3 years
- •Informed consent signed by the subject
- •PSA blood test within 60 days prior to registration
- •Prostate biopsy with Gleason score and TNM staging within one year prior to registration
- •No evidence of metastasis on computed tomography (CT) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to registration
- •No evidence of metastasis on bone scan within 120 days prior to registration
- •Within 60 days prior to registration, hematologic minimal values: absolute neutrophil count \> 1,500/mm\^3
- •Within 60 days prior to registration, hematologic minimal values: hemoglobin \> 8.0 g/dl
排除标准
- •History of urological surgery or procedures predisposing to genitourinary (GU) complications after radiation, i.e., anastomoses, stricture repair, transurethral resection, etc. (will be determined by radiation oncologist)
- •Prior thermal ablative therapy for prostate cancer (e.g. high-intensity focused ultrasound \[HIFU\] or cryoablation)
- •Documented distant metastatic disease
- •Patient with other co-morbidities that in the opinion of the treating physician would be a contra-indication to protocol participation (e.g. inflammatory bowel disease)
- •Mental incompetence or criminal incarceration
研究组 & 干预措施
Treatment (high dose rate brachytherapy, hyperthermia)
Patients undergo high dose rate brachytherapy for 15-30 minutes. Immediately after radiation therapy (no longer than 90 minutes), patients undergo interstitial hyperthermia treatment for up to 60 minutes.
干预措施: High-Dose Rate Brachytherapy
Treatment (high dose rate brachytherapy, hyperthermia)
Patients undergo high dose rate brachytherapy for 15-30 minutes. Immediately after radiation therapy (no longer than 90 minutes), patients undergo interstitial hyperthermia treatment for up to 60 minutes.
干预措施: Hyperthermia Treatment
Treatment (high dose rate brachytherapy, hyperthermia)
Patients undergo high dose rate brachytherapy for 15-30 minutes. Immediately after radiation therapy (no longer than 90 minutes), patients undergo interstitial hyperthermia treatment for up to 60 minutes.
干预措施: Laboratory Biomarker Analysis
结局指标
主要结局
Incidence of dose limiting toxicity defined as >= grade 3 per National Cancer Institute Common Toxicity Criteria version 4 occurring within 90 days of treatment and at least possibly attributed to radiation therapy and/or hyperthermia
时间窗: Up to 90 days
Will be computed with the corresponding 90% exact binomial confidence intervals.
次要结局
- Incidence of long-term toxicity associated with combined salvage high dose rate (HDR) brachytherapy and interstitial hyperthermia(Up to 5 years)
- Efficacy of combined salvage HDR brachytherapy and interstitial hyperthermia as defined by nadir PSA =< 0.5 mg/ml and freedom from biochemical failure per the Phoenix definition (nadir + 2)(Up to 5 years)