CTIS2022-503040-41-00招募中1 期
An international prospective open-label, multi-center, randomized, non-comparative phase II study of lutetium [177Lu] vipivotide tetraxetan (AAA617) alone and lutetium [177Lu] vipivotide tetraxetan (AAA617) in combination with androgen receptor pathway inhibitors in patients with PSMA PET scan positive castration-resistant prostate cancer (PSMACare) - CAAA617B12203
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- Male
入选标准
- •Participants must be adults = 18 years of age with signed informed consent prior to participation to study, Histologically or cytologically confirmed prostate cancer, Participants must have ongoing androgen deprivation therapy with a GnRH agonist/antagonist or prior bilateral orchiectomy, Castrate level of serum testosterone (< 1.7 nmol/l [50 ng/dl]) on GnRH agonist or antagonist therapy or after bilateral orchiectomy, Participants must have evidence of PSMA-positive disease as seen on a AAA517 or piflufolastat F 18 PET/CT scan at baseline as determined by Blinded Independent Central Review (BICR) based on the methodology proposed in the Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) (Eiber et al 2018). Participants with M1 disease only on PSMA PET scan are allowed to participate, Participants must have a negative conventional imaging for M1 disease., PSA Doubling Time (PSADT) of = 10 months, Participants must have adequate organ functions: bone marrow reserve, hepatic & renal
排除标准
- •Prior or present evidence of metastatic disease as assessed locally by CT/MRI for soft tissue disease and whole-body radionuclide bone scan for bone disease. Exception: Participants with soft tissue pelvic disease may be eligible (e.g., lymph nodes below bifurcation of common iliac arteries (N1) is permissible if the short axis of the largest lymph node is <20 mm). Participants with M1 disease on PSMA PET scans are also allowed to participate., Unmanageable concurrent bladder outflow obstruction or urinary incontinence. Note: participants with bladder outflow obstruction or urinary incontinence, which is manageable with best available standard of care (incl. pads, drainage) are allowed, Active clinically significant cardiac disease: history of seizure or condition that may pre-dispose to seizure which may require treatment with surgery or radiation therapy, Prior therapy with: second generation anti-androgens (e.g., enzalutamide, apalutamide and darolutamide); CYP17 inhibitors (e.g., abiraterone acetate, orteronel, galeterone, ketoconazole; radiopharmaceutical agents (e.g., Strontium-89), PSMA-targeted radioligand therapy; immunotherapy (e.g., sipuleucel-T); chemotherapy, except if administered in the adjuvant/neoadjuvant setting, completed > 2 years before randomization; any other investigational agents for CRPC; use of estrogens, 5-a reductase inhibitors (finasteride, dutasteride), other steroidogenesis inhibitors (aminoglutethamide) or first-generation anti-androgens (bicalutamide, flutamide, nilutamide, cyproterone) within 28 days before randomization; radiation therapy (external beam radiation therapy [EBRT] and brachytherapy within 28 days before randomization, Other concurrent cytotoxicity chemotherapy, immunotherapy, radioligand therapy, poly adenosine diphosphate-ribose polymerase (PARP) inhibitor, biological therapy or investigational therapy
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