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临床试验/NCT07489729
NCT07489729已完成不适用

Hypo Fractionated Versus Conventional IMRT in Unfavorable Intermediate- and High-Risk Prostate Cancer: A Phase II Comparative Study of PSA Kinetics and Dosimetric Outcomes

Tanta University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Tumor response

研究概览

简要总结

The aim of the study is

  1. Statistical evaluation of patients' characteristics who have intermediate & high risk localized prostate cancer.
  2. Statistical analysis of treatment efficacy of combined hormonal therapy & hypo fractionated intensity modulated radiotherapy compared with conventionally fractionated radiotherapy plus hormonal treatment as regard biochemical failure, disease free survival & overall survival.
  3. Evaluation of acute as well as late toxic side effects after radiotherapy.

详细描述

The incidence rate of prostate cancer is rapidly increasing, and it has become the most prevalent solid tumor diagnosed in men.

In most cases the prostate cancer is organ-confined at the time of initial diagnosis . Radical prostatectomy and radiotherapy, either given as a seed implant or external beam radiation therapy, are the accepted standard options for treating the primary tumor itself, and androgen deprivation may be added selectively for certain cases with an intermediate or high risk of dissemination based on clinical and pathologic features evident at the time of diagnosis.

Regarding the specific option of external beam radiotherapy, the current widely accepted standard regimen for organ-confined prostate cancer involves approximately eight weeks of fractionated treatments with a daily dose of 1.8-2.0 Gy to a total dose in the range of 70-80 Gy .

Over the last decade, there have been three major advances in the use of external RT for the management of clinically localized prostate cancer: (a) androgen deprivation therapy ; (b) image-guided ration therapy with three-dimensional conformal radiotherapy and intensity modulated radiotherapy , and particularly c) radiation dose escalation schedules compared with conventional 70-80 Gy (2 Gy per fraction), which has been shown to improve biochemical and distant metastases control with minimum toxicity, but not overall survival .

The rapid dose gradients, which are able to be generated with Intensity Modulated Radiation Therapy have been demonstrated to reduce OAR dose relative to three-dimensional conformal radiotherapy resulting in well-established reductions in toxicity in the conventionally fractionated, dose escalated prostate cancer radiotherapy setting .

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Biopsy proven prostate adenocarcinoma
  • Patient has been classified as intermediate or high risk according to the National Comprehensive Cancer Network v2018 .
  • Clinically localized stage (cT2-T3b N0M0, using the AJCC 8th TNM classification) .
  • Eastern Cooperative Oncology Group performance status ranged from 0-1 . - Mean age was 65 years (range: 50-80 years).
  • a prostate-specific antigen test at the time of diagnosis ≥10 ng/ml.
  • Gleason scores range from 7 to
  • The patient must not receive any cytotoxic anticancer therapy for prostate cancer prior to randomization.
  • Adequate hematological, hepatic, renal function tests

排除标准

  • Patients with a history of other malignancies, except: non-melanoma skin cancer.
  • Patients with any contraindication to pelvic radiotherapy: including, previous pelvic radiotherapy, inflammatory bowel disease or severe bladder irritability.
  • Patients who had prior surgical treatment for carcinoma of the prostate apart from trans-urethral resection,
  • Nodal or distant metastasis proven by a computed tomography pelvis or bone scan,
  • Co-morbidities as Congestive heart failure, recent myocardial infarction.

结局指标

主要结局

Tumor response

时间窗: Three monthly the first year after radiation, 4 months the second and third year.

Evaluation of tumor response will be performed by digital rectal examination, prostate-specific antigen, testosterone levels and Magnetic resonance imaging abdomen \& pelvis with contrast 3-monthly the first year after radiation therapy, 4-monthly the second and third year.

次要结局

  • Overall survival(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nada Samir Shams El-Din El-Behiri

Assistant lecturer

Tanta University

研究点 (1)

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