Primary Radical Prostatectomy Versus Primary Radiotherapy for Locally Advanced Prostate Cancer: an Open Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 48
- 主要终点
- Cause specific survival
研究概览
简要总结
This prospective, open randomized phase III surgical trial seeks to study whether radical prostatectomy (with or without the combination of external radiation) improves prostate-cancer specific survival in comparison with primary radiation treatment and hormonal treatment among patients diagnosed with locally advanced (T3) prostate cancer. Untreated or conservatively treated locally advanced prostate cancer is associated with high mortality. Modern curative treatment for advanced solid malign tumors include surgery and/or radiation plus attempted chemotherapy if available to achieve both local control and elimination of potential micro metastases. Whereas there is evidence that surgery can cure localized prostate cancer, there are no clinical trials of multi-modal treatment of locally advanced prostate cancer that includes surgical removal of the prostate.
One potential advantage of adding prostatectomy to the treatment of LAPC is that removing the prostate enables a full pathological assessment of the tumor characteristics and thus a better estimation of the risk of recurrence. Surgical treatment could thus reduce the numbers needed to treat with chemotherapy and radiation, and thus improve quality of life after treatment. In addition, evidence indicate that residual cancer in the prostate occurs in 25% after radiation treatment (56) and surgical removal of the prostate may improve survival beyond what can be achieved by radiation and ADT. On the other hand, patients treated with surgery, radiation and hormones will experience side effects of all three treatment modalities and might fare better if radiotherapy plus hormones can provide oncological control without prior surgery.
A randomized clinical trial comparing two multimodal treatment regimens of which one includes a radical prostatectomy is therefore warranted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≤75, at the time of randomization
- •Diagnosed histopathologically confirmed and untreated prostatic adenocarcinoma
- •The general condition and mental status of patients shall permit observation in accordance with the study protocol
- •Tumor stage (T, M, N):
- •T3 stage (as indicated by digital rectal examination or MR imaging or other validated imaging technique) T4 tumors can be included if considered resectable/treatable on MR imaging Significant extra-capsular tumor extension in biopsy (rare but acceptable for inclusion) M0 (no sign of distant metastases) confirmed by bone scan or CT or MRT of axial skeleton (at a maximum of pelvis and lumbar vertebral column) N0 stage, defined in accordance to the RECIST guidelines as no sign of macroscopic retroperitoneal lymph-node metastases >=1.5 cm (short axis) on CT scan, PET-CT, or MRT or more than one suspected lymph-node metastases Presence Gleason grade pattern 4 or 5
- •Signed Informed consent
排除标准
- •Patients with a PSA value of > 100 ng/mL
- •Any medical condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives Patients with contraindications for either prostatectomy or radiotherapy to the prostate are not eligible for the study. Most contraindications for these treatments are relative, but in general, radiotherapy may be precluded among patients with:
- •Anorectal disease, such as fistulae, Crohn´s disease, and ulcerative colitis
- •Significant obstructive lower urinary tract symptoms
- •Proximal stricture of the urethrae
- •Severe neurogenic bladder dysfunction
- •Enlarged prostate beyond 70-90 ml
- •Previous radiotherapy to the pelvic region
- •On the other hand, surgery may be precluded among patients with:
- •Massive local tumor progression, particularly in the apical region
- •Massive abdominal obesity
- •Contraindications to anesthesia
结局指标
主要结局
Cause specific survival
时间窗: Up to 10 years
Cause-specific survival (CSS) will be calculated as "1-cause specific mortality. Mortality and mortality causes will be ascertained from the nationwide Cause-of-Death Register. In the absence of a functioning Cause-of-Death register, an endpoint committee of at least 2 medical doctors will determine the cause of death.
次要结局
- Overall survival(Up to 10 years)
- Adverse events(Up to 10 years)
- Metastasis free survival(Up to 10 years)
- Cardiovascular disease(Up to 10 years)
- Quality of life - general psychological, urinary, bowel and sexual health(At 1,2,5 and 10 years after randomization)
- Time to castration-resistant prostate cancer(Up to 10 years)
- Time to biochemical progression(Up to 10 years)
研究者
Olof Akre
Professor
Karolinska University Hospital