A Prospective Phase II Study of Salvage Brachytherapy in Combination With Interstitial Hyperthermia for Locally Recurrent Prostate Carcinoma Following External Beam Radiation Therapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 77
- 试验地点
- 3
- 主要终点
- Rate of late GI/GU grade 3 and more toxicities
研究概览
简要总结
Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy.
详细描述
Salvage brachytherapy in combination with interstitial hyperthermia for locally recurrent prostate carcinoma following external beam radiation therapy:
Salvage brachytherapy: HDRBT: 3 x 10 Gy specified on prostate capsule/tumor margin (d1, 22, 43) or PDRBT: 2 x 30 Gy specified on prostate capsule/tumor margin (d1-3, 29-31) Hyperthermia: prostate heated to 40 - 47˚C for 30-60 minutes (60 minutes recommended) prior to brachytherapy dose delivery. Maximum temperature in surrounding critical normal organs should not exceed 43˚C
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologically-confirmed locally recurrent prostate cancer - biopsy performed < 6 months before registration;
- •Histology: Adenocarcinoma, every Gleason score (2-10)
- •Initial treatment (EBRT) completed > 24 months prior to biopsy;
- •Androgen deprivation therapy for prostate cancer should be discontinued at least 3 months prior to patient registration
- •Staging performed within 12 weeks prior to registration:
- •Local stage evaluated by DRE, TRUS or - if necessary - mpMRI (T1b, T1c, T2a, T2b, T2c, T3a, T3b);
- •Negative lymph nodes by imaging studies (at least one of these: choline PET scan, pelvic ± abdominal CT or MRI) or by lymphadenectomy (cN0 or pN0);
- •Negative bone scan (M0);
- •PSA-DT > 6 months (PSA measurements taken of the 12 months prior to registration)
- •Zubrod Performance Scale 0-2 (Appendix V) International Prostate Symptoms Score (IPSS) < 20 (Appendix VI), the IPSS score can be evaluated in patient on alpha-blockers;
- •Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade 0-1 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 4.
- •In TRUS volume study performed 0-4 weeks before registration patient meets eligibility criteria for prostate brachytherapy as follows:
- •Prostate/tumor volume <60ml
- •The distance rear prostate edge - rectal mucosa >5mm
- •Interference of pubic arch ruled out
- •If local stage T3b: it must be possible to cover by the brachytherapy dose cancer infiltration
- •Prostate lenght (from apex plane to base plane) ≤ 45mm (technical criterion for 915 MHz frequency antennas)
- •The patient is suitable for spinal or general anesthesia
- •Age > 18 y.
- •Life expectancy > 5 years
- •absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •The patient must sign a study-specific informed consent form before study registration
排除标准
- •Severe, active comorbidities:
- •Decompensated congestive heart disease
- •Chronic obstructive pulmonary disease exacerbation, respiratory failure
- •Hepatic insufficiency resulting in coagulation defects or clinical jaundice
- •Other active malignancy or treatment of invasive or hematological malignancy
- •Evidence of extraprostatic disease at local recurrence:
- •Local stage T4
- •Histologic or radiologic evidence of lymph node metastases (N1 or pN1)
- •Presence of distant metastases (M1)
- •Any of the following prior therapies:
- •TURP within 6 months prior to registration
- •Prostatic salvage cryosurgery performed at least 6 months before registration
- •HIFU performed at least 6 months before registration
- •Androgen deprivation therapy within 3 months prior to registration
- •Baseline gastrointestinal (GI) or genitourinary (GU) toxicity grade ≥ 2 as defined in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
研究组 & 干预措施
Treatment Arm
The physician can choose either HDR or PDR brachytherapy.
If HDR BT is chosen:
d1: hyperthermia (IHT) 60 minutes + 10Gy HDR brachytherapy (HDRBT) d22: IHT 60 minutes + 10 Gy HDRBT d43: IHT 60 minutes + 10 Gy HDRBT
If PDR BT is chosen:
d1-3: IHT 60 minutes + 30Gy PDRBT d29-31: IHT 60 minutes + 30Gy PDRBT
干预措施: Brachytherapy (Radiation)
Treatment Arm
The physician can choose either HDR or PDR brachytherapy.
If HDR BT is chosen:
d1: hyperthermia (IHT) 60 minutes + 10Gy HDR brachytherapy (HDRBT) d22: IHT 60 minutes + 10 Gy HDRBT d43: IHT 60 minutes + 10 Gy HDRBT
If PDR BT is chosen:
d1-3: IHT 60 minutes + 30Gy PDRBT d29-31: IHT 60 minutes + 30Gy PDRBT
干预措施: Hyperthermia (Other)
结局指标
主要结局
Rate of late GI/GU grade 3 and more toxicities
时间窗: up to 60 Months in Follow up
次要结局
- Disease-free survival(up to 60 Months in Follow up)
- Time to biochemical failure(up to 60 Months in Follow up)
- Clinical patterns of tumor recurrence(up to 60 Months in Follow up)
- Rate of acute GI/GU treatment-related adverse events(up to 24 months after start of recruitment)
- Overall survival(up to 60 Months in Follow up)
- Disease-specific survival(up to 60 Months in Follow up)
研究者
Vratislav Strnad
Assistant Medical Director of the Dept. of Radiooncology
University of Erlangen-Nürnberg Medical School