A Phase I-II Study to Evaluate Exclusive Single-fraction Irradiation by Interstitial High Dose Rate Brachytherapy in Patients With Prostate Cancer at Low Risk or at Low Intermediate Risk of Local Recurrence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- acute urinary toxicity occurring within 6 months after irradiation.
研究概览
简要总结
Recently, HDR brachytherapy delivering only a 19 Gy fraction was proposed as exclusive treatment for low and intermediate risk prostate cancers. With a median 3-year follow-up, the Spanish team reported a biochemical control rate of 100% and 87%, respectively, for low risk and intermediate risk tumors. In parallel with these encouraging results regarding biochemical control, the authors described excellent urinary and digestive tolerance, notably the absence of grade > 2 complications. However, it should be noted, in this study, that special protection was provided to the anterior aspect of the rectum by means of a 10 ml transperineal injection of hyaluronic acid into the prostate-rectal interspace.
The idea of using a single high dose (in one fraction) was proposed at the MSKCC by the team of Fucks et al. which, in 2008, following a median 18-month follow-up, published a a 90% local control rate for spinal metastases after a single dose at 18 to 24 Gy.
The aim of the present study is to analyze acute urinary and digestive toxicity (< 180 days) observed following interstitial high dose rate prostate brachytherapy delivering a total dose of 20 Gy in one fraction.
详细描述
Expected benefit(s) of the trial
-
Improved quality of life during brachytherapy on account of the absence of radioactive seeds in the prostate:
-
Fewer early urinary complications,
-
No urine filtration,
-
No post-operative use of condoms,
-
No 2-year ban on cremation following treatment,
-
Health cost savings,
-
Acquisition of dosimetric data for inverse optimization.
Predictable risk(s) for patients Predictable risks in the context of this trial involve the frequency of essentially urinary disorders.
Methodology Open, monocentric, phase I-II study.
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
- •Patients suffering from histologically-proven adenocarcinoma-type prostate cancer:
- •with low risk of biochemical recurrence
- •with a low intermediate risk of biochemical recurrence (maximum of 1 intermediate risk factor)*
- •stage T1c, T2a, T2b
- •Gleason score 6 (3+3) or 7 (3+4) with at most 3 positive biopsies
- •PSA < 15 ng/ml
- •Age ≥ 18 years
- •Karnofsky index ≥ 70%
- •Life expectancy ≥ 10 years
- •No contraindication to injection of hyaluronic acid in the prostate-rectal interspace
- •Patient aware of the information leaflet and having signed the informed consent form
- •Patient covered by medical insurance
排除标准
- •Stage ≥ T2c
- •Gleason score 7 (4+3) or ≥ 8
- •PSA > 15 ng/ml
- •Presence of the following anatomico-pathological criteria:
- •Involvement of the nerve fibers
- •Peri-tumoral vascular embolisms
- •Capsule involvement
- •Number of positive biopsies ≥ 50%
- •100% positive biopsies in a lobe
- •Involvement of the seminal vesicle
- •Prostate volume ≥60 cc
- •Large prostatic transurethral resection and/or dating from less than 6 months
- •Poor urinary function in the absence of alpha-blockers
- •IPSS score > 15
- •Post-mictional residue > 50 cc
- •Flow rate with Qmax < 12 ml/s
- •Remote metastasis
- •Neoadjuvant anti-androgenic treatment
- •Prior treatment with pelvic irradiation and/or chemotherapy
- •Active infection or other underlying severe pathology likely to prevent the patient from receiving treatment
- •History of cancer other than basocellular cutaneous cancer or other form of cancer in complete remission for more than 5 years
- •Evolving psychiatric disorder
- •Vulnerable persons as defined by article L1121-5 to -8
研究组 & 干预措施
exclusive single-fraction irradiation
干预措施: exclusive single-fraction irradiation (Radiation)
结局指标
主要结局
acute urinary toxicity occurring within 6 months after irradiation.
时间窗: up to 5 years
to assess the acute urinary toxicity occurring within 6 months after irradiation.
次要结局
- acute digestive toxicity occurring during the 6 months following irradiation(up to 5 years)