177-Lutetium-PSMA Neoadjuvant to Ablative Radiotherapy for Oligorecurrent Prostate Cancer (Lunar)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Prostate-specific membrane antigen positron emission tomography/computerized tomography (PSMA PET/CT)-based progression-free survival (PFS)
研究概览
简要总结
This phase II trial tests whether 177-Lutetium-PSMA given before stereotactic body radiotherapy (SBRT) works to improve cancer control rate in patients with 1-5 prostate cancer tumors that have come back after prior treatment (oligorecurrent). Radioactive drugs, such as 177-Lutetium-PSMA, may carry radiation directly to tumor cells and not harm normal cells. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving 177-Lutetium-PSMA before SBRT may make the SBRT more effective.
详细描述
PRIMARY OBJECTIVE:
I. To assess progression-free survival for men with oligorecurrent prostate cancer after stereotactic body radiotherapy (SBRT) versus SBRT plus neoadjuvant lutetium Lu-177 PNT2002 (177Lu-PNT2002), with progression defined on the basis of prostate-specific membrane antigen positron emission tomography/computerized tomography (PSMA PET/CT) scans obtained at standard intervals (12 months and 24 months post-SBRT) or at the time of prostate-specific antigen (PSA)-based biochemical progression, or initiation of salvage therapy or death.
SECONDARY OBJECTIVES:
I. To evaluate disease burden of disease (including local control of irradiated lesions and presence of other disease) on a PSMA PET/CT obtained 24 months after SBRT of SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease who have not progressed by that point.
II. To assess physician-scored toxicity (Common Terminology Criteria for Adverse Events version 5.0 [CTCAE v 5.0]) of SBRT versus SBRT + 177Lu-PNT2002 in patients with oligometastatic disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Oligorecurrent prostate cancer as determined by the presence of 1-5 asymptomatic lesions outside the prostate or prostate bed identified on PSMA PET/CT by local readers
- •Age >= 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •No indication for urgent or emergent radiation
- •Histologic confirmation of prostate adenocarcinoma (histology from original treatment acceptable)
- •White blood cell count >= 2.5 × 10^9/L
- •Platelets >= 100 × 10^9/L
- •Hemoglobin >= 9 g/dL
- •Total bilirubin =< 1.5 × institutional upper limit of normal (ULN); or up to 3 × ULN if known history of Gilbert's syndrome
- •Alanine aminotransferase or aspartate aminotransferase =< 3.0 × ULN or =< 5.0 × ULN for patients with liver metastases
- •Serum creatinine =< 1.5 × ULN or creatinine clearance >= 50 mL/min
- •Serum albumin > 3.0 g/dL
- •Partner and patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principal investigator during the study and for 3 months after last study drug administration
- •Ability to understand, and willingness to sign, the written informed consent
排除标准
- •Patients with neuroendocrine or small cell carcinoma of the prostate
- •Patients with castrate-resistant disease (i.e., PSA > 0.5 ng/mL with serum testosterone < 150 ng/dL)
- •Patients who received androgen deprivation therapy within 6 months of trial enrollment
- •Concurrent systemic therapy for a solid organ malignancy
- •Spinal cord compression
- •Inability to lie flat
- •Known hypersensitivity to components of 177Lu-PNT2002
- •Serum creatinine > 1.5 × ULN or creatinine clearance < 50 mL/min
- •Total bilirubin > 1.5 × ULN or > 3.0 × ULN if known history of Gilbert's syndrome
- •Alanine aminotransferase or aspartate aminotransferase > 3 × ULN (or 5 × ULN for patients with known liver metastases)
- •De novo oligometastatic disease
研究组 & 干预措施
Arm 1 (SBRT)
Beginning on day 1, patients undergo SBRT to all lesions for 1, 3, or 5 treatment doses (fractions) over the span of 10-20 days in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Arm 1 (SBRT)
Beginning on day 1, patients undergo SBRT to all lesions for 1, 3, or 5 treatment doses (fractions) over the span of 10-20 days in the absence of disease progression or unacceptable toxicity.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
Arm 2 (177Lu-PNT2002, SBRT)
Patients receive 177Lu-PNT2002 IV over 1-10 minutes on days -112 and -56 in the absence of disease progression or unacceptable toxicity. Beginning on day 1, patients then undergo SBRT to all lesions for 1, 3, or 5 treatment doses (fractions) over the span of 10-20 days in the absence of disease progression or unacceptable toxicity.
干预措施: Lutetium Lu-177 PNT2002 (Drug)
Arm 2 (177Lu-PNT2002, SBRT)
Patients receive 177Lu-PNT2002 IV over 1-10 minutes on days -112 and -56 in the absence of disease progression or unacceptable toxicity. Beginning on day 1, patients then undergo SBRT to all lesions for 1, 3, or 5 treatment doses (fractions) over the span of 10-20 days in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Arm 2 (177Lu-PNT2002, SBRT)
Patients receive 177Lu-PNT2002 IV over 1-10 minutes on days -112 and -56 in the absence of disease progression or unacceptable toxicity. Beginning on day 1, patients then undergo SBRT to all lesions for 1, 3, or 5 treatment doses (fractions) over the span of 10-20 days in the absence of disease progression or unacceptable toxicity.
干预措施: Stereotactic Body Radiation Therapy (Radiation)
结局指标
主要结局
Prostate-specific membrane antigen positron emission tomography/computerized tomography (PSMA PET/CT)-based progression-free survival (PFS)
时间窗: Time from the date of stereotactic body radiotherapy (SBRT) completion to the date of disease progression or death, whichever happens earlier, assessed up to 24 months
Will compare PSMA PET/CT-based PFS for patients with oligoprogressive prostate cancer treated with SBRT to all known sites of disease on PSMA PET/CT versus patients treated with 177Lu-PNT2002 prior to SBRT to all known sites of disease. PSMA PET/CT-based progression is defined as either (a) a new lesion on PSMA PET/CT with or without a serum prostate-specific antigen (PSA) increase or (b) local progression on PSMA (\> 30% increase in lesion standard uptake value \[SUV\] or increase of \> 20% in the sum of the longest diameter of all target lesions), regardless of new lesions, and a serum PSA increase. A serum PSA increase for the purposes of this definition will be based on the definition of PSA-based progression. The Kaplan-Meier (KM) method will be used to summarize PFS and log-rank test will be used to compare PFS between the two arms.
次要结局
- Disease progression(At 24 months)
- PSA-based progression(Up to 24 months)
- Time to local progression (TTLP)(Time from completing SBRT to identification of progression of treated lesions, assessed up to 60 months)
- Time to new metastasis (TNM)(Time from completing SBRT to the time of a new documented tumor metastasis by PSMA PET/CT, assessed up to 24 months)
- Overall survival (OS)(Time from starting treatment until death due to any cause, assessed up to 60 months)
- Local control (LC)(Time from starting treatment until local relapse is documented by PSMA PET/CT based criteria, assessed up to 24 months)
- Time to progression(Time from completing SBRT to the time of first documented tumor progression or new lesions by PSMA PET/CT or initiation of ADT, assessed up to 60 months)
- Incidence of adverse events (AEs)(Up to 60 months)
- Patient-reported quality of life as reported by the Brief Pain Inventory form(Baseline up to 1 year)
- Androgen deprivation therapy-free survival (ADT-FS)(Time from starting treatment to the time of initiation of palliative ADT, assessed up to 60 months)
- Regional control (RC)(Time from starting treatment until regional relapse is documented by PSMA PET/CT based criteria, assessed up to 24 months)
- Duration of complete response (CR) or partial response (PR)(From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that current or progressive disease is objectively documented, assessed up to 60 months)