jRCT2031250104尚未招募不适用
NeoPSMA: A Phase I/II, open-label, multi-center study of neoadjuvant treatment with [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in adults with prostate-specific membrane antigen (PSMA) positive high-risk localized prostate cancer (HRLPC) prior to radical prostatectomy and pelvic lymph node dissection (CAAA802B12101)
Novartis Pharma. K.K.0 个研究点目标入组 4 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4
- 主要终点
- Number of participants with dose-limiting toxicities (DLTs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- Male
入选标准
- •Adults >= 18 years of age.
- •Participants must have PSMA-positive disease as assessed by PSMA PET/CT scan using a PSMA imaging agent as protocol instructed, with eligibility being determined by the sponsor's central reading rules.
- •Histologically confirmed high-risk adenocarcinoma of an intact prostate, and Gleason score >= 8 and/or PSA > 20 nanogram per milliliters (ng/mL) and/or >= cT3a.
- •Adequate organ function:
- •Bone marrow reserve:
- •White blood cell (WBC) count >= 3.0 x 10*9/L and absolute neutrophil count (ANC) >= 1.5 x 10*9/L.
- •Platelets >= 75 x 10*9/L.
- •Hemoglobin >= 8 g/dL
- •Hepatic function:
- •Total bilirubin =< 1.5 x the institutional upper limit of normal (ULN). For participants with known Gilbert's Syndrome =< 3 x ULN is permitted.
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3.0 x ULN
- •Albumin > 3.0 g/dL
- •Renal function:
- •Creatinine clearance >= 60 mL/min. Note that participants with findings indicating blockage of urinary outflow are not eligible. No evidence of congenital renal abnormalities with known effect on renal function or voiding abnormalities that may interfere, in the opinion of the principal investigator, with the safe administration of the study treatment.
- •An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or
- •Indicated to receive radical prostatectomy (RP) and pelvic lymph node dissection (PLND).
- •Sexually active participants with female partners of childbearing potential are eligible to participate if they agree to follow one of the following methods of contraception consistently, starting from screening, during the study and for at least 6 months after the last dose of study treatment:
- •Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.
- •Are sterilized (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate);
- •Agree to use a male condom and have their partner use a highly effective method of contraception (failure rate < 1% per year) as described in Section 8.4.6 when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant, and who agrees to the use of a condom by her partner.
- •In addition, participants must refrain from donating sperm starting from Screening, during the study and for at least 6 months after the last dose of the study medication.
- •Sexually active participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse; or use a male condom during each episode of penile penetration during the study.
排除标准
- •Subjects taking prohibited therapies as described in the protocol
- •Any approved or investigational systemic anti-cancer therapy (e.g. chemotherapy, investigational therapy, immunotherapy or biological therapy including monoclonal antibodies) administered for the treatment of HRLPC within 28 days (or 5 times the half-life of that therapy whichever is longer) of the anticipated day C1D
- •Previous treatment with any approved or investigational radioligand therapy, approved or investigational radioisotopes.
- •Prior or concurrent radiation therapy of the prostate, other prostate antineoplastic ablative procedures, or hormonal ablation for prostate cancer.
- •Diagnosed with other active malignancies that are expected to alter life expectancy or may interfere with disease assessment. Participants with a prior history of malignancy that has been adequately treated and who have been disease free and treatment free for more than 3 years prior to randomization are eligible, as are participants with adequately treated non-melanoma skin cancer and superficial bladder cancer.
结局指标
主要结局
Number of participants with dose-limiting toxicities (DLTs)
Phase l
Biochemical recurrence free survival (BFS)
Phase ll
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
2 期
A Study Evaluating [177Lu]Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in Taxane Treatment Naive Chinese Male Patients With Progressive Metastatic Castrate Resistant Prostate CancerMetastatic Castration-Resistant Prostate Cancer (mCRPC)NCT05658003Novartis Pharmaceuticals63
进行中（未招募）
2 期
EVOLUTION: 177Lu-PSMA Therapy Versus 177Lu-PSMA in Combination With Ipilimumab and Nivolumab for Men With mCRPCGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsProstatic DiseaseProstate CancerProstatic NeoplasmsNCT05150236Australian and New Zealand Urogenital and Prostate Cancer Trials Group93
进行中（未招募）
3 期
An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With Standard of Care (SoC), Versus SoC Alone, in Adult Male Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC)Prostatic NeoplasmsNCT04720157Novartis Pharmaceuticals1,140
招募中
3 期
Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPCProstate CancerNCT06855277Novartis Pharmaceuticals940
进行中（未招募）
2 期
In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to ChemotherapyMetastatic Hormone Naive Prostate CancerNCT04343885Peter MacCallum Cancer Centre, Australia130