Prospective Trial of Combination External Beam Radiation Therapy and MRI-guided, Dose-differentiated High Dose-rate Prostate Brachytherapy Boost for Unfavorable-intermediate, High, and Very High-risk Prostate Cancer

University of Virginia2 个研究点分布在 1 个国家目标入组 60 人2025年1月30日

适应症Prostate Cancer Prostate Adenocarcinoma

干预措施External Beam Radiation HDR Brachytherapy Androgen Deprivation Therapy

相关药物Androgen Deprivation Therapy

概览

阶段: 2 期
干预措施: External Beam Radiation
疾病 / 适应症: Prostate Cancer
发起方: University of Virginia
入组人数: 60
试验地点: 2
主要终点: Compare GU toxicity rate to the rate published in the ASCENDE-RT trial
状态: 进行中（未招募）
最后更新: 5天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This study is trying to find out if the combination of Androgen deprivation therapy (ADT), MRI guided high dose radiation (HDR) brachytherapy treatment (internal radiation implant procedure) and external beam radiation therapy (EBRT) treatments lead to less side effects. This study is also looking at patient outcomes, quality of life, and overall survival for patients receiving this treatment.

注册库

clinicaltrials.gov

开始日期

2025年1月30日

结束日期

2029年1月30日

最后更新

5天前

研究类型

Interventional

研究设计

Single Group

性别

Male

研究者

发起方

University of Virginia

责任方

Principal Investigator

主要研究者

Christopher Luminais, MD

Assistant Professor of Radiation Oncology

University of Virginia

入排标准

入选标准

•Provision of signed and dated informed consent form.
•Stated willingness to comply with all study procedures and availability for the duration of the study.
•Male, aged 18 or above.
•Histologic proven diagnosis of cancer of the prostate up to one year before registration.
•Unfavorable-intermediate risk, high risk, or very high-risk prostate cancer as determined by the NCCN Guidelines Version 4.2019 (Section 12.4).
•History and physical exam completed up to 6 months before registration.
•PSA value \< 50 ng/mL prior to androgen deprivation therapy and up to 12 months before registration. Subjects who do not meet this criteria's timeframe due to extenuating circumstances (i.e. COVID-19 quarantine, changes to their treatment plan, etc) but meet all other eligibility criteria may still be eligible. The PI will review each case and decide
•ECOG performance status 0 or
•Pelvic MRI obtained up to 12 months before registration.
•Candidate for receiving the combination of HDR brachytherapy and EBRT, with or without ADT. The ADT may have begun prior to study enrollment.

排除标准

•Evidence of bone metastases.
•Diagnosis of a prior invasive malignancy (except for non-melanoma skin cancer), unless the participant has been disease-free for at least 3 years.
•Patient has had previous radical surgery (prostatectomy) or cryosurgery for prostate cancer.
•Patient has had previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy.
•Patient has had prior radiotherapy, including brachytherapy, to the region of this study cancer that would result in overlap of radiation therapy fields.
•Patient has had previous or concurrent cytotoxic chemotherapy for prostate cancer (prior chemotherapy for different cancer is allowed).
•Patient has MRI incompatible metallic implant(s) that cannot be removed.
•The patient has severe or active co-morbidities as defined by the following:
•Unstable angina and/or congestive heart failure requiring hospitalization up to 6 months (180 days) before registration
•Transmural myocardial infarction up to 6 months (180 days) before registration