NCT06943495招募中1 期
PROstate-specific Membrane Antigen DosImetry- Guided endoradiotherapY: A Randomized- Controlled, Single-blind, Pilot Study of Personalized vs. Fixed-activity 177Lu-PSMA-617 Radiopharmaceutical Therapy (PRODIGY-2)
Jean-Mathieu Beauregard1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月15日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Administered activity of 177Lu-PSMA-617
研究概览
简要总结
The goal of this clinical trial is to assess if a personalized regime of 177Lu-PSMA-617 (Lutetium Lu 177 vipivotide tetraxetan, also known as Pluvicto) is feasible and safe in a population of patients with metastatic castrate-resistant prostate cancer (mCRPC). The main questions it aims to answer are:
- Can the administered activity (cumulative or per-cycle) be increased in a majority of participants?
- What is the incidence of some specific adverse reactions during the treatment?
Researchers will compare participants receiving a personalized regime to participants receiving the standard fixed-activity regime of 177Lu-PSMA-617 to see if the activity can be safely increased through personalization based on renal dosimetry (i.e. the measure of how much radiation is actually delivered to the kidney).
Participants will receive up to 6 treatments of 177Lu-PSMA-617 every 6 weeks and be regularly evaluated with imaging and laboratory tests, as well as with questionnaires.
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
- Single (Participant)
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
- •Patient aged ≥18 years with metastatic adenocarcinoma of the prostate, defined by documented histopathology of prostate adenocarcinoma;
- •Castration-resistant prostate cancer, as defined as disease progressing despite castration by orchiectomy or ongoing androgen deprivation therapy;
- •Progressive mCRPC with rising PSA level, defined by PCWG3 criteria (sequence of two rising values above a baseline at a minimum of 1-week intervals, with serum testosterone level ≤ 1.7 nmol/dL);
- •PSA ≥2 ng/mL ;
- •Prior treatment with at least one ARPI;
- •PSMA-expressing cancer, with significant PSMA expression defined as SUVpeak in at least one lesion that is superior to SUVmean of the liver on PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL), within 45 days prior to randomization;
- •ECOG Performance status 0 to 2;
- •Calculated eGFR (by CKD-EPI formula) ≥ 45 mL/min/1.73m^2;
- •Albumin ≥ 25 g/L;
- •Platelets ≥ 100x10^9/L;
- •Neutrophils ≥ 1.5x10^9/L;
- •Hemoglobin ≥ 90 g/L without transfusion in the past 4 weeks;
- •Signed, written informed consent
排除标准
- •PSMA-PET "superscan" (i.e. extensive/diffuse PSMA-positive bone involvement);
- •Site(s) of disease that are FDG-positive, defined as SUVpeak in at least one lesion that is superior to twice (2x) SUVmean of the liver, and PSMA-negative (as above), within 45 days prior to randomization;
- •Prior treatment with more than two lines of chemotherapy for mHSPC and/or mCRPC (adjuvant and neoadjuvant chemotherapy does not count) towards the maximum of two regimens);
- •Prior radiopharmaceutical therapy;
- •Known CNS metastasis unless they are deemed to be non-progressive, asymptomatic and off corticosteroid therapy for at least four weeks, as per investigator's assessment;
- •Active malignancy other than prostate cancer;
- •Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception;
- •Any other condition, diagnosis or finding that may in the investigator's opinion interfere with trial conduct;
- •Known hypersensitivity to 177Lu-PSMA-617 or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
研究组 & 干预措施
Personalized activity
Experimental
干预措施: 177Lu-PSMA-617 (Drug)
Fixed activity
Active Comparator
干预措施: 177Lu-PSMA-617 (Drug)
结局指标
主要结局
Administered activity of 177Lu-PSMA-617
时间窗: From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)
In GBq, cumulative and average per cycle.
Number of participants with subacute adverse events of special interest (AESIs)
时间窗: From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)
Subacute AESIs are: * treatment-related grade 3-4 thrombopenia persisting more than 12 weeks * treatment-related grade 3-4 neutropenia persisting more than 12 weeks * treatment-related creatinine elevation to \>2x baseline and \>ULN (upper limit of normal) persisting more than 12 weeks * treatment-related grade 4 febrile neutropenia * treatment-related grade 4 non-hematological toxicity
次要结局
- Variation of score on Multidisciplinary Salivary Gland Society (MSGS) questionnaire at baseline(At baseline, at 18 weeks, and at the end of treatment (each cycle is 6 weeks, up to 6 consecutive cycles))
- Number of participants with any adverse events (AEs)(From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles))
- Best biochemical response(From first administration until 52 weeks or the start of another anti-cancer treatment or death, whichever is earliest)
- PSA progression-free survival (PSA-PFS)(From date of first administration until the date of PSA progression or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months)
- Best radiological response rates(From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles))
- Radiological progression-free survival (rPFS)(From date of first administration until the date of radiological progression or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months)
- Investigator-assessed overall PFS(From date of first administration until the date of investigator-assessed progression or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months)
- Time to first symptomatic skeletal event (SSE)(From date of first administration until the date of first SSE or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months)
- Overall survival (OS)(From date of first administration until the date of death, assessed over a minimum of 60 months)
- Metabolic response on FDG-PET/CT(At baseline and at 12 weeks)
- Molecular response on PSMA-PET/CT(At baseline and at the end of treatment (each cycle is 6 weeks, up to 6 consecutive cycles))
- Best molecular response on quantitative 177Lu SPECT/CT during treatment(From first cycle's Day 3 until the last cycle's Day 3 (each cycle is 6 weeks, up to 6 consecutive cycles))
- Number of participants with laboratory adverse events (AEs)(From date of first administration until the date of investigator-assessed progression or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months)
- Number of participants with delayed adverse events of special interest (AESIs)(From date of first administration until the date of death, assessed over a minimum of 60 months)
- Variation of score on EuroQol-5 Dimension-5 Level (EQ-5D-5L) questionnaire at baseline(At baseline, at 18 weeks, and at the end of treatment (each cycle is 6 weeks, up to 6 consecutive cycles))
- Variation of score on Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire at baseline(At baseline, at 18 weeks, and at the end of treatment (each cycle is 6 weeks, up to 6 consecutive cycles))
- Variation of score on Brief Pain Inventory (BPI-SF) questionnaire at baseline(At baseline, at 18 weeks, and at the end of treatment (each cycle is 6 weeks, up to 6 consecutive cycles))
研究者
Jean-Mathieu Beauregard
Nuclear Medicine Physician
CHU de Quebec-Universite Laval
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical TherapyMetastatic CancerCancerProstate CancerMetastatic Prostate CancerNCT05896371CHU de Quebec-Universite Laval500
招募中
不适用
Kidney Function and Risk Factors in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) Undergoing 177Lutetium-PSMA Radioligand Therapy: a Prospective Observational Study - KiRi-TrialRadiation NephropathyMetastatic Castrate Resistant Prostate Cancer (mCRPC)Kidney DiseaseNCT06720532Hannah Schaefer100
进行中（未招募）
1 期
Dosimetry, Safety and Potential Benefit of 177Lu-PSMA-617 Prior to ProstatectomyProstatic NeoplasmsNCT04430192Peter MacCallum Cancer Centre, Australia20
招募中
2 期
Low PSMA SUV Boost (LPS-Boost): Intensified 177Lu-PSMA-617 Treatment for Patients With Metastatic Castrate-Resistant Prostate Cancer With Low PSMA Expressing DiseaseStage IVB Prostate Cancer AJCC v8NCT06526299University of Washington51
已完成
1 期
Phase 1 of EC1169 In Patients With Recurrent MCRPCProstate CancerNCT02202447Endocyte40