Addition of Focal Boost to Primary Radiotherapy for Prostate Cancer in 12 or 20 Fractions: A Large DAPROCA Randomised Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,016
- 试验地点
- 3
- 主要终点
- Freedom from distant metastasis
研究概览
简要总结
Every year, about 700 Danish men get radiotherapy for prostate cancer with a high-risk of later progression. The risk of relapse is about 40 % after 5 - 8 years, so we need better treatment for these patients in Denmark and globally. The aim is to reduce later cancer spreading, need of hormone treatments and prostate cancer death.
DAPROCA 10 tests two possible improvements:
If a higher dose (boost) to intra-prostatic tumor lesions improves cure rates. If the radiotherapy can be given with 12 treatment fractions instead of 20 without increased side-effects.
In this randomised trial half the participants get a boost and the other half don't. Half the patients get 12 treatments, the other half 20.
To answer these questions we must include1016 participants. The trial is feasible because the technological advances in imaging and radiotherapy enables us to define the tumors in the prostate and to deliver the boost to the tumors with high precision, without increased dose to the surrounding organs.
详细描述
Addition of focal boost to primary radiotherapy for prostate cancer in 12 or 20 fractions: A large DAPROCA randomised trial.
Purpose
The DAPROCA multidisciplinary group is planning a large trial to answer two pertinent questions of how to improve radiotherapy for high - and intermediate risk prostate cancer:
- Will increasing dose to intra-prostatic cancer lesions improve outcomes with respect to prostate cancer without increasing toxicity?
- Is it possible to shorten the treatment without increased toxicity?
The success of both increased dose to intra-prostatic cancer lesions and shortening of treatment, which means treatment with fewer treatment fractions with higher dose per fraction, is most likely dependent on high quality, high precision radiotherapy (RT) planning and delivery. A French randomised trial in prostate cancer demonstrated improved rectal toxicity scores (p=<0.03) and biochemical control with image guidance, and the MIRAGE randomised trial demonstrated improvements with smaller margins and more precise delivery (1-3). Many European clinics, including the Danish RT-clinics are able to provide high quality RT to all patients as per national consensus guidelines and in this study, we aim to further develop and implement this high quality opportunities in order to deliver hypofractionated RT and to boost the dose to intraprostatic lesions in all participating centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 with biopsy verified PCa with no distant metastases with either
- •Intermediate- or high-risk PCa, defined as at least one of the following risk criteria:
- •Clinical stage cT2c-T3b (UICC TNM 8th edition)
- •Imaging stage, T3a or T3b
- •≥ Gleason score 4+3, (ISUP Grade groups 3,4 or 5)
- •Regional lymph node metastases N1
- •Age > 18
- •WHO score 0-1
- •Intraprostatic lesion visible on MRI
- •Suitable for focal boost
- •Ability to give written informed consent and willingness to return for follow-up
排除标准
- •WHO performance status ≥ 2
- •If, for any patient related reason, an MRI cannot be performed
- •International prostate symptom score (IPSS) ≧ 20
- •If fiducial markers cannot be inserted
- •TURP within 3 months from start of treatment
- •Previous pelvic irradiation
- •If the patient is judged by the physician to be unable to adhere to trial activities
- •History of chronic inflammatory bowel disease (CIBD)
研究组 & 干预措施
20 treatment fractions no boost
Prostate and seminal vesicles: 60 Gy/ 20 fractions. Pelvic: 45 Gy /20 fractions.
干预措施: Addition of focal boost and hypofractionation (Radiation)
20 treatment fractions, boost
Boost to intra-prostatic lesions: 75 Gy/20 fractions, prostate and seminal vesicles: 60 Gy/ 20 fractions. Pelvic: 45 Gy /20 fractions.
干预措施: Addition of focal boost and hypofractionation (Radiation)
12 treatment fractions, no boost
Prostate and seminal vesicles: 50 Gy/ 12 fractions, Pelvic: 37 Gy /12 fractions.
干预措施: Addition of focal boost and hypofractionation (Radiation)
12 fractions, boost
Boost to intraprostatic lesions: 60 Gy/12 fractions, prostate and seminal vesicles: 50 Gy/12 fractions, pelvic: 37 Gy /12 fractions.
干预措施: Addition of focal boost and hypofractionation (Radiation)
结局指标
主要结局
Freedom from distant metastasis
时间窗: Time from enrollment to confirmation of occurence of radigraphic distant metastases. The patients are followed for 123 months after start of radiotherapy.
Metastses is verified by PSMA scan which is recommended: * If a recurrence is suspected biochemically according to biochemical relaps accordingly to the Phoenix criteria * If a recurrence is suspected clinically, e.g: Bone pain, anemia, urinary symptoms * If recurrence is suspected by radiographic test Biopsy is also accepted and MRI, CT, bone scintigraphy, NAF-PET, ultrasound or clinical examination may also be accepted with further confirmation, e.g. biopsy or laboratory tests. If the event "distant metastasis" is based on tests without biopsy or PSMA positivity the event shall be confirmed at a multi-disciplinary tumor board.
次要结局
- Freedom from biochemical relapse(Time from enrollment to confirmation of occurence of biochemical relapse. PSA is measured by a blood test regularly until 123 months after start of radiotherapy.)
- Time to salvage hormonal therapy(Time from enrollment to intiation of salvage hormonal therapy. Hormone treatment is recordet at regular patient visits until 123 months after start of radiotherapy.)
- Regional relapse-free survival(Time from enrollment to confirmation of regional relapse-free survival. Time Frame: The patients are followed for 123 months after start of radiotherapy.)
- Local relapse-free survival(Time from enrollment to confirmation of local relapse. The participants are followed for 123 months after start of radiotherapy)
- Overall survival(Time from enrollment to death of any cause. Cause and time of death is collected for up to 20 years.)
- Prostate cancer specific survival(Time from enrollment to death of prostate cancer. Cause and time of death is collected for up to 20 years.)
- Self-reported quality of life(Reported at baseline and 3 months, 1 year, 2 years 5 years after start of radiotherapy.)
- Self reported quality of life(Reported at baseline and 3 months, 1 year, 2 years 5 years after start of radiotherapy.)
- Toxicity as CTCAE(Reported at baseline and 3 months, 1 year, 2 years 5 years after start of radiotherapy.)
研究者
Peter Meidahl Petersen
MD, Ph.D.
Rigshospitalet, Denmark