招募中 NCT07130682

MRI引导下两次分次质子治疗前列腺癌:一项第二期试验

前列腺癌不适用PSMA

本研究正在测试一种使用质子治疗(PT)的较短程前列腺癌治疗方法,质子治疗非常精准,与传统放射治疗相比可能引起较少副作用。然而,其费用昂贵且许多患者难以获得。为使其更可负担及更易获得,本研究正在测试2次分次的立体定向身体质子治疗(SBPT)能否与标准5次治疗同样安全有效。

适应症:Prostate Cancer Patients Treated by Radiotherapy

入组条件

纳入标准

  • Men aged \< 18 years with histologically confirmed low- or intermediate-risk prostate cancer per NCCN guidelines
  • Eastern Cooperative Oncology Group (ECOG) performance status \<2
  • Ability to undergo magnetic resonance imaging (MRI) simulation scans without absolute contraindications, such as cardiac implantable electronic devices
  • Ability to complete the Expanded Prostate Cancer Index Composite (EPIC) questionnaire

排除标准

  • History of inflammatory bowel disease or other cancers (except prostate cancer)
  • Prior pelvic radiotherapy, chemotherapy, radical prostatectomy, cryosurgery, or focal therapy (e.g. high-intensity focused ultrasound \[HIFU\]) for prostate cancer
  • History of bladder neck or urethral stricture
  • Transurethral resection of the prostate (TURP) \< 8 weeks prior to SBPT
  • Prostate volume \> 100cc on MRI
  • Unilateral or bilateral hip replacements
  • Nodal or distant metastases, as indicated by computed tomography (CT), MRI, or prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scans
  • Previous androgen deprivation therapy (ADT) lasting more than 6 months

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。