Phase I/II Multi-center Study Evaluating the Efficacy of Repeat Stereotactic Radiation in Patients With Intraprostatic Tumor Recurrence After External Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- UNICANCER
- 入组人数
- 57
- 试验地点
- 12
- 主要终点
- Selection of the recommended dose for salvage-SBRT (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy) based on dose-limiting toxicity observed during the 18 weeks following the initiation of salvage-SBRT.
研究概览
简要总结
Stereo-Re-Pro aims to provide further evidence of Stereotactic Body Radiotherapy (SBRT) as a supplementary non-invasive curative treatment for local recurrence following radiotherapy.
The objective of the first part of the trial (Phase I) is to select the recommended dose for salvage SBRT (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy) based on dose-limiting toxicity observed during the 18 weeks following the initiation of salvage-SBRT. Particular attention will be paid to the quality of life and tolerance of the treatment.
The objective of the second part of the trial (phase II) is to estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate.
详细描述
To date, no standard local treatment exists for patients with an intraprostatic recurrence after radiotherapy. A number of treatments options exist including: radical prostatectomy, brachytherapy, High-intensity focused ultrasound (HIFU), cryotherapy, and stereotactic radiotherapy. These treatments are associated with a variety of genitourinary and gastrointestinal toxicities and complications. In recent years, stereotactic radiotherapy has been used to treat localized prostate cancer in the primary setting but also as a salvage treatment after failure of radiotherapy. The initial results of these studies are promising, with respect to survival and tolerance, but further studies are required to confirm these initial results.
The objective of STEREO-RE-PRO is to prospectively evaluate salvage SBRT for intraprostatic recurrent prostate cancer after primary external radiotherapy. This study will select patients for whom there is no standard local treatment.
After inclusion and non-inclusion criteria have been verified and the patient has consented, the site will register the screening and organize the baseline visit with the placement of fiducial markers within two months before the planned start of SBRT.
Once the fiducial placement has been performed and all eligibility criteria fully reviewed, the site will register the patient's participation so that the bio-statistician allocates the dose of SBRT. The dose will be allocated upon a model-based estimates provided by the statistical team and confirmed by the trial steering committee. Five or six fractions, at a level of 5 or 6 Gy per session (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy), will be delivered over a maximum of 12 days to provide a total dose of 25 to 36 Gy. During the treatment phase of the study, no study specific visits are scheduled and the patients will be followed as per standard of care.
A follow-up visit is planned at 6, 10, 18 weeks from the start of SBRT for safety evaluation. Subsequent follow-up visits are planned at 6, 9, 12, 18, 24, 30, and 36 months after the start of radiotherapy. Thereafter, yearly follow-up visits at 48, 60, and 72 months after starting SBRT will be planned after the initial 3-year follow-up period. M72 visit corresponds to the end of study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- •Biochemical recurrence occurring at least 2 years after external radiotherapy for prostatic adenocarcinoma by the Phoenix definition (PSA nadir + 2 ng/mL)
- •T1-T2c and PSA ≤20 ng/mL and Gleason score ≤7 at initial diagnosis of prostate cancer before the initial/first treatment.
- •Recurrence of prostatic adenocarcinoma proven by histology following radiotherapy by transrectal or transperineal sextant biopsies of the two lobes of the prostate, with a minimum of 12 biopsies, irrespective of Gleason score. Biopsies of the seminal vesicles are optional.
- •Clinical stage T1-T2 on relapse; unilateral extracapsular extension (T3a) on MRI permitted except posteriorly relative to the rectum
- •Estimated clinical target volume (CTV) / prostate volume < 0.5 based on imaging and biopsies
- •Pelvic and prostatic assessment by multiparametric MRI- Absence of pelvic or metastatic recurrence proven by choline PET scan
- •Performance status World Health Organization (WHO) 0-1
- •PSA level ≤10 ng/mL at baseline (before salvage-SBRT)
- •PSA doubling time >10 months
- •International Prostate Cancer Score (IPSS) ≤12
- •Uroflowmetry with a maximum flow rate >10 mL/s, a postvoid residual urine volume <150 mL, and a urine volume >150 mL.
- •No other anti-cancer treatment since the external radiotherapy administered as first-line treatment
- •No other anti-cancer treatment planned for the current recurrence
- •No contraindication to fiducial marker implants; haemostatic disorders must be corrected before implantation
- •Age >18 years
- •Life-expectancy greater than or equal to 5 years (Lee scale)
- •Patient registered with a health insurance system
- •Patient who has signed the informed consent form
- •Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.
排除标准
- •Lymph node or metastatic spread
- •Late post-radiotherapy urinary or gastrointestinal toxicity of grade ≥2 (following primary radiotherapy)
- •Other cancers in the last 5 years except for non-melanoma-type skin cancer
- •History of inflammatory bowel disease
- •Anticoagulant treatment
- •Contraindications to undergoing MRI
- •Prostate volume >80 cc
- •Transurethral resection of the prostate (TURP) in the 6 months before registrations
- •Presence of rectal telangiectasia grade 3 classified by the Vienna Rectoscopy Score (obligatory rectoscopy)
- •Previous rectal surgery
- •Patients unable to undergo medical follow-up in the study for geographical, social or psychological
- •Person deprived of their liberty or under protective custody or guardianship
- •Patients enrolled in another therapeutic study
- •All patients during the SBRT planning with a ratio of clinical target volume (CTV) / prostate volume >0.5 will be withdrawn from the study. These patients will be considered as not evaluable and will not be treated within the context of the study.
研究组 & 干预措施
SBRT at a total dose of 30 Gy
Placement of fiducials marker seeds in the prostate followed by the administration of stereotactic body radiotherapy at 30 Gy (5 sessions at a level of 6 Gy each- 1 session per day) 30 Gy is the first dose-level. During the treatment phase of the study, no study specific visits are scheduled and the patients will be followed as per standard of care.
干预措施: Stereotactic Body Radiotherapy (Radiation)
SBRT at a total dose of 25 Gy
Placement of fiducials marker seeds in the prostate followed by the administration of stereotactic body radiotherapy at 25 Gy (5 sessions at a level of 5 Gy each- 1 session per day) During the treatment phase of the study, no study specific visits are scheduled and the patients will be followed as per standard of care.
干预措施: Stereotactic Body Radiotherapy (Radiation)
SBRT at a total dose of 36 Gy
Placement of fiducials marker seeds in the prostate followed by the administration of stereotactic body radiotherapy at 36 Gy (6 sessions at a level of 6 Gy each- 1 session per day) During the treatment phase of the study, no study specific visits are scheduled and the patients will be followed as per standard of care.
干预措施: Stereotactic Body Radiotherapy (Radiation)
结局指标
主要结局
Selection of the recommended dose for salvage-SBRT (either 5 x 6 Gy, 6 x 6 Gy, or 5 x 5 Gy) based on dose-limiting toxicity observed during the 18 weeks following the initiation of salvage-SBRT.
时间窗: 18 weeks
The dose-escalation part of the study will terminate once 10 patients have been treated and evaluated at a dose currently identified as the recommended dose.
Estimate the efficacy of the salvage-SBRT in terms of biochemical relapse-free survival rate
时间窗: 6 years
次要结局
- Evaluation of Quality of life after salvage-SBRT(6 years)
- Evaluation of acute and late genitourinary toxicities of the salvage-SBRT(3 years)
- Estimate the efficacy of the salvage-SBRT in terms of clinical progression-free survival and overall survival(6 years)