Intensity-modulated, hypofractionated radiotherapy with scanning beam protons for locally advanced carcinoma of the prostate and localized carcinoma of the prostate with risk factors - a phase II study - HypoPros I

Westdeutsches Protonentherapiezentrum Essen (WPE)0 个研究点目标入组 133 人开始时间: 2017年3月23日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•histological proven carcinoma of the prostate (moderate or high risk profile, i.e. PSA > 10 ng/ml and/or Gleason Score = 7 and/or stage T2b-T3b)
•- performance status according to WHO = 2
•- willingness to use contraception
•- PSA < 50 ng/ml
•- given informed consent for participation

•- Evidence of distant metastasis and metastatic lymph nodes
•- Indication for irradiation of the pelvic lymphatic drainage
•- Pre-irradiation in the area of the prostate
•- Pre-surgery in the area of the prostate or rectum
•- Transurethral resection (TUR) < 3 months ago
•- Previous systemic chemotherapy
•- History of previous tumor disease of another organ (except non-melanoma skin cancer or basal cell carcinoma). Patient has to be tumor-free for 3 years.
•- Hip implants
•- Cardiac pacemaker
•- Medical or psychiatric impairments which impede treatment or late follow-up
•- Diagnosis of chronic inflammatory bowel disease (colitis ulcerosa, morbus Crohn), even if currently controlled
•- Pre-existing gastrointestinal and genitourinary toxicity = Grad 2, that is defined as primary endpoint

发起方

Westdeutsches Protonentherapiezentrum Essen (WPE)