Hypofractionated Focal Lesion Ablative Microboost in prostatE cancer (Hypo-FLAME) - Hypo-FLAME

niversitair Medisch Centrum Utrecht0 个研究点目标入组 85 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- Men >= 18 years with histologically confirmed prostate adenocarcinoma;
•- Intermediate-risk prostate cancer or high-risk prostate cancer, defined as at least one of the following risk criteria:
•* Clinical T-stage T2b, T2c or T3a (defined on MRI) or T3b with less than 5 mm invasion in the seminal vesicle.
•* Gleason sum score >= 7.
•* Prostate specific antigen (PSA) >= 10 ng/mL.
•- Prostate tumor nodule visible on MRI;
•- Ability to give written informed consent and willingness to return for follow-up.

•- Prior pelvic radiotherapy, transurethral prostate resection or prostatectomy;
•- Unsafe to have gold fiducial marker implantation;
•- Contraindications to MRI according to the Radiology Department guidelines (metal implants, non-compatible cardiac device, allergy to Gadolinium, severe renal dysfunction or severe claustrophobia);
•- Evidence of lymph node involvement or distant metastatic disease;
•- Clinical T-stage > T3b with >= 5 mm invasion in theseminal vesicle;
•- World Health Organization (WHO) performance score > 2;
•- International prostate symptoms score (IPSS) >= 15;
•- PSA >30 ng/mL.

发起方

niversitair Medisch Centrum Utrecht