Re-Treatment With 177Lu-PSMA-617 Molecular Radiotherapy for Metastatic Castration Resistant Prostate Cancer: A Prospective Phase 2 Trial (RE-LuPSMA STUDY)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 12-month overall survival
研究概览
简要总结
This phase II trial tests how well re-treatment with 177Lu-PSMA-617 works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic), that continues to grow or spread after the surgical removal of the testes or medical treatment to block androgen production (castration-resistant), and that has shown a favorable response to initial treatment with 177Lu-PSMA-617. 177Lu-PSMA-617 is a radioactive drug. It binds to a protein called prostate specific membrane antigen (PSMA), which is expressed by some types of prostate tumor cells. When 177Lu-PSMA-617 binds to PSMA-expressing tumor cells, it delivers radiation to the cells, which may kill them. Re-treatment with 177Lu-PSMA-617 in patients who had a favorable response to initial 177Lu-PSMA-617 treatment may improve survival outcomes and disease response in patients with metastatic castration-resistant prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. To assess the treatment efficacy of re-challenge lutetium Lu 177 vipivotide tetraxetan (177Lu-PSMA-617) therapy (for a maximum of 6 additional cycles) in patients with metastatic castration-resistant prostate cancer (mCRPC) who had a favorable response to a prior regimen of 177Lu-PSMA-617 therapy.
SECONDARY OBJECTIVES:
I. To determine the safety of re-challenge 177Lu-PSMA-617 therapy by Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
II. To determine the rate of patients who have a prostate-specific antigen (PSA) response (defined as a PSA decline of ≥ 50% during re-challenge 177Lu-PSMA-617 therapy).
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
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must have mCRPC
- •Patients must have received at least one regimen of chemotherapy for mCRPC
- •Patients must have received at least one androgen receptor signaling inhibitor (ARSI)
- •Patients must have previously completed at least 4 cycles of 177Lu-PSMA-617 therapy
- •Patients must have had a favorable response to the first regimen of 177Lu-PSMA-617 therapy defined as:
- •PSA decline of ≥ 50% at any time during the first regimen of 177Lu-PSMA-617 therapy AND
- •No new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation androgen deprivation therapy [ADT] is allowed). Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed
- •Patients must have had a PSA increase after the first regimen of 177Lu-PSMA-617 therapy, confirmed by a second measurement ≥ 3 weeks apart
- •Patients must meet PSMA PET/CT VISION criteria. PSMA PET/CT must have been completed within 8 weeks of the planned first cycle of re-challenge 177Lu-PSMA-617 therapy and at least 6 weeks after completion of the first regimen of 177Lu-PSMA-617 therapy
- •White blood cells > 2,500 cells/µL
- •Absolute neutrophil count > 1,500 cells/µL
- •Hemoglobin > 9.0 g/dL
- •Platelets > 100,000 cells/µL
- •Patients must have the ability to understand and sign an approved informed consent form (ICF) and comply with all protocol requirements
排除标准
- •Patient received new prostate cancer therapy within two months of completing the first regimen of 177Lu-PSMA-617 therapy (first-generation ADT (adenosine triphosphate) is allowed). This can include apalutamide, enzalutamide, abiraterone, chemotherapy, immunotherapy, radionuclide therapy, PARP inhibitor, or any biological therapy. Concomitant prostate cancer therapy that was administrated during the first regimen of 177Lu-PSMA-617 therapy and continued afterwards is allowed
- •Patient received myelosuppressive therapy (including docetaxel, cabazitaxel, 223Ra, and 153Sm) or other radionuclide therapy within the last 6 weeks
- •Patient with creatinine clearance < 50 mL/min
研究组 & 干预措施
Treatment (177Lu-PSMA-617)
Patients receive 177Lu-PSMA-617 IV on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gallium Ga 68 gozetotide IV and undergo PET/CT at screening and on study, undergo SPECT/CT on study, and undergo collection of blood samples throughout the trial.
干预措施: Biospecimen Collection (Procedure)
Treatment (177Lu-PSMA-617)
Patients receive 177Lu-PSMA-617 IV on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gallium Ga 68 gozetotide IV and undergo PET/CT at screening and on study, undergo SPECT/CT on study, and undergo collection of blood samples throughout the trial.
干预措施: Computed Tomography (Procedure)
Treatment (177Lu-PSMA-617)
Patients receive 177Lu-PSMA-617 IV on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gallium Ga 68 gozetotide IV and undergo PET/CT at screening and on study, undergo SPECT/CT on study, and undergo collection of blood samples throughout the trial.
干预措施: Gallium Ga 68 Gozetotide (Other)
Treatment (177Lu-PSMA-617)
Patients receive 177Lu-PSMA-617 IV on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gallium Ga 68 gozetotide IV and undergo PET/CT at screening and on study, undergo SPECT/CT on study, and undergo collection of blood samples throughout the trial.
干预措施: Lutetium Lu 177 Vipivotide Tetraxetan (Drug)
Treatment (177Lu-PSMA-617)
Patients receive 177Lu-PSMA-617 IV on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gallium Ga 68 gozetotide IV and undergo PET/CT at screening and on study, undergo SPECT/CT on study, and undergo collection of blood samples throughout the trial.
干预措施: Positron Emission Tomography (Procedure)
Treatment (177Lu-PSMA-617)
Patients receive 177Lu-PSMA-617 IV on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gallium Ga 68 gozetotide IV and undergo PET/CT at screening and on study, undergo SPECT/CT on study, and undergo collection of blood samples throughout the trial.
干预措施: Questionnaire Administration (Other)
Treatment (177Lu-PSMA-617)
Patients receive 177Lu-PSMA-617 IV on day 1 of each cycle. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive gallium Ga 68 gozetotide IV and undergo PET/CT at screening and on study, undergo SPECT/CT on study, and undergo collection of blood samples throughout the trial.
干预措施: Single Photon Emission Computed Tomography (Procedure)
结局指标
主要结局
12-month overall survival
时间窗: Assessed at 12 months
12-month overall survival (OS) of patients with mCRPC who previously had a favorable response to a first regimen of 177Lu-PSMA-617 and are treated with re-challenge 177Lu-PSMA-617 therapy
次要结局
- Biochemical progression-free survival (PFS)(Assessed approximately at 2 years)
- Overall survival from the end of the first regimen(Assessed approximately at 2 years)
- Bone Pain(approximately 36 weeks.)
- Changes in health-related quality of life_Functional Assessment of Cancer Therapy - Radionuclide Therapy (FACT-RNT).(approximately 36 weeks.)
- Changes in health-related quality of life_Brief Pain Inventory Short form(approximately 36 weeks.)
- Changes in health-related quality of life_ Eastern Cooperative Oncology Group score(approximately 36 weeks.)
- Rate of prostate specific antigen (PSA) response(Assessed approximately at 36 weeks)
- Incidence of adverse events (AEs)(Assessed approximately at 2 years)
- Overall Survival from start of first regimen(Assessed approximately at 2 years)
- Radiographic progression-free survival (rPFS)(approximately two years.)