Phase 1 Trial to Determine Safety and Feasibility in Treating Biochemical Recurrence Post-Prostatectomy With PSMA PET Guided External Beam Radiotherapy Followed by Consolidative Radioligand Therapy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Incidence of radiotherapy and radioligand therapy related adverse events
研究概览
简要总结
This phase I trial tests the safety, side effects and best dose of radioligand therapy (lutetium Lu 177 PSMA-10.1 [177Lu-rhPSMA-10.1]) after prostate specific membrane antigen (PSMA) positron emission tomography (PET)-guided external beam radiotherapy in treating post-prostatectomy patients with prostate cancer that has come back after a period of improvement (recurrent). In this study, radioligand therapy is a radioactive drug called 177Lu-rhPSMA-10.1. It works by binding to PSMA-expressing prostate tumor cells and delivering the radioactive portion of the drug directly to the tumor cells while not harming normal cells. Radiation therapy such as external beam radiotherapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radioligand therapy with PSMA PET-guided external beam radiotherapy may kill more tumor cells in post-prostatectomy patients with biochemically recurrent prostate cancer.
详细描述
PRIMARY OBJECTIVES:
I. Demonstrate the safety and feasibility of treating radiotherapy (RT) prostate cancer patients via addition of lutetium Lu 177 PSMA-10.1 (177Lu-rhPSMA-10.1) in a selected post-prostatectomy population.
II. Analyze dosimetry of radioligand therapy (RLT) after each cycle of 177Lu-rhPSMA-10.1.
EXPLORATORY OBJECTIVE:
I. Determine the feasibility of and develop preliminary data in the correlation of circulating tumor circulating tumor deoxyribonucleic acid (ctDNA) at baseline, after RT, and RLT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adenocarcinoma of the prostate, post radical prostatectomy with detectable prostate specific antigen (PSA)
- •Clinical PSMA PET/CT obtained, with findings of pelvic uptake only (prostate bed, pelvic lymph node uptake, or both)
- •Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status of 0-2
- •Age over 18
排除标准
- •Contraindications to radiotherapy (including active inflammatory bowel disease or prior pelvic radiotherapy or prior RLT)
- •Risk factors for Lu-rhPSMA radioligand therapy (Baseline >= grade 2 myelosuppression, renal insufficiency [glomerular filtration rate (GFR) < 60 mL/min], or xerostomia)
- •Definitive findings of systemic metastasis prior imaging (if obtained) or biopsy (if obtained)
- •Unacceptable medical or radiation safety risk
- •Unmanageable urinary tract obstruction or hydronephrosis; patients with diagnosed or who are at high risk of urinary retention
- •GFR < 60 mL/min or creatinine > 1.5-fold upper limit of normal (ULN)
- •Liver enzymes > 5-fold ULN
- •Total white cell count less than 2.5 x 10^9 /L
- •Platelet count less than 75 x 10^9 /L
- •Any baseline grade 2 or above myelosuppression, nephrotoxicity, hepatotoxicity, xerostomia, or gastrointestinal (GI) toxicity
- •Severe acute co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization in the last 3 months
- •Transmural myocardial infarction within the last 6 months
- •Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- •Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- •Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immunocompromised patients
研究组 & 干预措施
Treatment (EBRT, 177Lu-rhPSMA-10.1)
Patients undergo EBRT followed by 177Lu-rhPSMA-10.1 IV on study. Patients also receive rhPSMA-7.3 IV with PET/CT at screening and undergo SPECT-CT and collection of blood samples on study.
干预措施: Biospecimen Collection (Procedure)
Treatment (EBRT, 177Lu-rhPSMA-10.1)
Patients undergo EBRT followed by 177Lu-rhPSMA-10.1 IV on study. Patients also receive rhPSMA-7.3 IV with PET/CT at screening and undergo SPECT-CT and collection of blood samples on study.
干预措施: Computed Tomography (Procedure)
Treatment (EBRT, 177Lu-rhPSMA-10.1)
Patients undergo EBRT followed by 177Lu-rhPSMA-10.1 IV on study. Patients also receive rhPSMA-7.3 IV with PET/CT at screening and undergo SPECT-CT and collection of blood samples on study.
干预措施: External Beam Radiation Therapy (Radiation)
Treatment (EBRT, 177Lu-rhPSMA-10.1)
Patients undergo EBRT followed by 177Lu-rhPSMA-10.1 IV on study. Patients also receive rhPSMA-7.3 IV with PET/CT at screening and undergo SPECT-CT and collection of blood samples on study.
干预措施: Flotufolastat F-18 (Other)
Treatment (EBRT, 177Lu-rhPSMA-10.1)
Patients undergo EBRT followed by 177Lu-rhPSMA-10.1 IV on study. Patients also receive rhPSMA-7.3 IV with PET/CT at screening and undergo SPECT-CT and collection of blood samples on study.
干预措施: Lutetium Lu 177 PSMA-10.1 (Drug)
Treatment (EBRT, 177Lu-rhPSMA-10.1)
Patients undergo EBRT followed by 177Lu-rhPSMA-10.1 IV on study. Patients also receive rhPSMA-7.3 IV with PET/CT at screening and undergo SPECT-CT and collection of blood samples on study.
干预措施: Positron Emission Tomography (Procedure)
Treatment (EBRT, 177Lu-rhPSMA-10.1)
Patients undergo EBRT followed by 177Lu-rhPSMA-10.1 IV on study. Patients also receive rhPSMA-7.3 IV with PET/CT at screening and undergo SPECT-CT and collection of blood samples on study.
干预措施: Single Photon Emission Computed Tomography (Procedure)
结局指标
主要结局
Incidence of radiotherapy and radioligand therapy related adverse events
时间窗: Up to 6 weeks post last radioligand therapy dose
Will be summarized descriptively using frequencies and percentages of all captured toxicities by grade and relevance.
次要结局
- ctDNA differences(Up to 5 years)
- Tumor and organ at risk dosimetry(At 1-3 days and 4-7 days post radioligand therapy)
- Circulating tumor deoxyribonucleic acid (ctDNA) differences(Up to 5 years)
研究者
David M Schuster
Principal Investigator
Emory University