A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs?
This study would like to find out if this approach is better or worse than the usual approach for prostate cancer.
The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).

开始日期2025-05-30

申办/合作机构

Canadian Cancer Trials Group

[+4]

ACTRN12624001458527

/ Not yet recruiting临床2期IIT

Randomised Phase 2 study of sphingosine kinase inhibitor (opaganib) in addition to darolutamide in people with poor prognostic metastatic castration resistant prostate cancer (mCRPC) based on a companion circulating lipid biomarker, PCPro (ANZUP2205)

开始日期2025-05-30

申办/合作机构

Australian & New Zealand Urogenital & Prostate Cancer Trials

NCT06931340

/ Not yet recruiting临床3期IIT

Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)

This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.

开始日期2025-05-08

申办/合作机构

Alliance for Clinical Trials in Oncology

[+1]

100 项与转移性前列腺腺癌相关的临床结果

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100 项与转移性前列腺腺癌相关的转化医学

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0 项与转移性前列腺腺癌相关的专利（医药）

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项与转移性前列腺腺癌相关的文献（医药）

2025-04-01·Clinical Imaging

CT-guided biopsy of 18F-piflufolastat radiotracer avid lesions in osseous metastatic prostate disease: Initial experience, technical factors and biopsy yield

Article

作者: Samim, Mohammad ; Burke, Christopher John ; Fenner, Jordan ; Shankar, Dhruv S ; Raad, Roy A

OBJECTIVESTo evaluate the yield of CT-guided biopsy of 18F-piflufolastat PET avid osseous lesions in suspected prostate metastases.METHODSRetrospective review of computed tomography guided biopsies targeting 18F-piflufolastat avid lesions on PET/CT or PET/MR performed between 2022 and 2024. Demographics, image modality, biopsy system, number of cores, lesion location, lean body mass corrected SUV (SUL) and pathology were recorded. Biopsied lesions were compared to the PROMISE (prostate cancer molecular imaging standardized evaluation) scoring system, version 2.RESULTSEighteen patients were included, average age 68.7 years. Lesions were defined as: ≥ 50 % sclerotic (n = 10), <50 % sclerotic (n = 7), occult (n = 0), and lytic (n = 1). A technically successful pathologic diagnosis was made in 94 % of biopsies (n = 17). Histopathological diagnosis included: metastatic prostate adenocarcinoma (n = 12), benign with fibrotic/densely sclerotic bone or normocellular bone marrow (n = 5), and metastatic non-small cell lung carcinoma (n = 1). The median SUL on PET for all patients was 7.9 (IQR 13.3), 2.6 (0.3) for benign biopsies, and 8.8 (12.5) for malignant biopsies. Major identifiable differences between biopsies yielding a metastatic versus benign diagnosis included: higher SUL (p-value = 0.03), target lesion volume (p-value = 0.01), and higher incidence of sclerotic lesions (p value = 0.003); however, multivariate analysis did not find these to be statistically significant predictors (p-value >0.05). The prostate cancer lesion biopsy positive group had significantly higher PROMISE scores than the negative group (p = 0.03).CONCLUSIONCT-guided biopsy of bone lesions demonstrating avidity for 18F-piflufolastat can be performed with a high diagnostic yield.

2025-03-18·Cureus

Bone Marrow Failure in Prostate Cancer: A Rare Case Initially Disguised as Thrombotic Thrombocytopenic Purpura

Article

作者: Dommaraju, Sunil R ; Shodiya, Michael ; Henick, Kathryn

Prostate cancer is the second most common cause of cancer-related death and the leading cause of new cancer cases in men in the United States. Bone trabeculae are the most common site of metastasis for prostate cancer, but bone marrow (BM) involvement is rare. Around six percent of patients with new metastatic castrate-sensitive prostate cancer (mCSPC) have biopsy-proven BM metastasis. We present a case of mCSPC with BM metastasis initially disguised as thrombotic thrombocytopenic purpura (TTP). Initial presentation revealed anemia and thrombocytopenia with a peripheral blood smear indicating thrombotic microangiopathy. Empiric treatment for TTP was initiated, but the patient showed no improvement. A BM biopsy performed on hospital day 5 for further work-up of the refractory cytopenias eventually identified metastatic prostate adenocarcinoma. The patient started androgen deprivation therapy, but attempts at follow-up care were unsuccessful. The patient passed away five months later. This case highlights the diagnostic complexity of cytopenias and contributes to our understanding of BM-metastatic prostate cancer. BM involvement in mCSPC complicates prognosis, and further research into its pathophysiology and targeted therapies is needed to improve patient outcomes.

2025-03-17·Cureus

Prostate Cancer With Orbital Metastasis

Article

作者: Singh, Lavi ; Ezekwudo, Daniel ; Elhalis, Abdullah ; Gopishetty, Swathi ; Aqil, Mohammad

Prostate cancer (PCa) is one of the most commonly diagnosed cancers in men worldwide, with an increasing incidence due to advancements in detection methods. The majority of PCa cases are sporadic, though a small percentage is hereditary. PCa primarily metastasizes to the bones, followed by lymph nodes, liver, and thorax. However, metastasis to atypical sites, including the orbit, remains exceedingly rare. Orbital metastasis from PCa is associated with a poor prognosis and can lead to significant visual impairment. This case report describes a 71-year-old male patient with a history of hypertension, atrial fibrillation, and obstructive uropathy, who presented with diplopia and left-sided ptosis. Imaging revealed a left intraconal orbital mass with intracranial extension, leading to the diagnosis of metastatic prostate adenocarcinoma. Further evaluation revealed extensive bone metastases and retroperitoneal lymphadenopathy. The patient was diagnosed with high tumor burden and castration-naïve metastatic PCa and treated with a combination regimen of androgen deprivation therapy, docetaxel, and darolutamide, resulting in significant reduction in prostate-specific antigen levels. Despite initial success in lowering tumor burden, the patient experienced side effects, including a rash, leading to discontinuation of chemotherapy. This case underscores the importance of considering PCa in the differential diagnosis of orbital tumors, despite its rarity. Surgical resection and palliative radiation were employed to manage the orbital mass, and ongoing treatment with denosumab was initiated to address the extensive bone metastases. This case highlights the clinical challenges and treatment considerations in patients with atypical metastatic spread of PCa and emphasizes the need for a multidisciplinary approach in managing such complex presentations.

项与转移性前列腺腺癌相关的新闻（医药）

2024-05-17

·拜耳中国

拜耳启动创新型靶向治疗放射性药物在晚期前列腺癌的I期研究

225Ac-PSMA-Trillium（BAY 3563254）是一种正在研究的下一代基于α粒子的PSMA靶向放射疗法，有可能用于治疗晚期转移性前列腺癌患者前列腺癌是全球男性第二常见癌症1，其中转移性去势抵抗性前列腺癌患者中位生存期小于三年拜耳致力于推进用于不同阶段前列腺癌患者的医疗创新近日，拜耳宣布在下一代靶向α疗法225Ac-PSMA-Trillium（BAY 3563254）的首次人体I期临床研究中开始给药。该研究候选化合物用锕-225标记，包含一种具有定制白蛋白结合部分的新型PSMA（前列腺特异性膜抗原）-靶向小分子，旨在改善治疗效果，减少在唾液腺等正常器官的不良反应。剂量递增研究（NCT06217822）将评估225Ac-PSMA-Trillium治疗晚期转移性去势抵抗性前列腺癌（mCRPC）患者安全性、耐受性和疗效。 “尽管前列腺癌治疗领域取得了最新进展，但仍有大量未满足的需求，需要新型的精准治疗方案来改善转移性去势抵抗性前列腺癌患者预后。”加拿大蒙特利尔大学外科教授，负责人，蒙特利尔大学医院中心（CHUM）泌尿生殖肿瘤主任Fred Saad医学博士介绍，“225Ac-PSMA-Trillium是一种新的手段，可以针对mCRPC中未满足的需求提供解决方法。” “靶向放射性核素治疗是拜耳精准肿瘤学的战略支柱。秉持改变患者治疗模式的承诺，这也包括那些患有疾病但对其他治疗方法产生耐药性的患者。”拜耳肿瘤研究和早期开发负责人Dominik Ruettinger医学博士说，“我们很高兴宣布I期研究中首位患者开始接受225Ac-PSMA-Trillium治疗。凭借其独特的设计，我们相信它可以为转移性前列腺癌患者提供有意义的临床获益，我们期待通过临床开发推进项目的开展。” 前列腺癌是全球男性第二常见的癌症，也是拜耳重点关注的关键领域。尽管在过去十年中取得了重要进展，mCRPC中位生存期约31个月，仍然是一种威胁生命疾病。拜耳致力于推进用于不同阶段前列腺癌患者的医疗创新。公司目前在该治疗领域拥有两款上市产品（诺倍戈®和多菲戈®）以及正在开发中的多款产品，包括225Ac-pelgifatamab (BAY 3546828)，该化合物是一种锕-225标记的PSMA靶向抗体螯合物，目前处于I期临床研究中。今年4月，拜耳在AACR（美国癌症研究协会）年会地平线新药会议上介绍了225Ac-PSMA-Trillium3。前列腺癌受试者中进行的0期临床成像和剂量测定研究结果，以及临床前的体外和体内特征描述均已发表。参考文献 1. GLOBOCAN. World fact sheet. 2022. Available at:https://gco.iarc.who.int/media/globocan/factsheets/populations/900-worldfact-sheet.pdf. Accessed March 2024. 2. Amit D Raval et al. Prediction model for real-world survival in men withcastration-resistant prostate cancer and bone metastases in the UnitedStates: A real-world database study. JCO Oncol Pract 19, 507-507 (2023). 3. Zitzmann-Kolbe S, et al. Presented at: American Association of ClinicalResearch Annual Meeting; April 5-10, 2024; San Diego, CA, USA. AbstractND09. 4. Parker C, et al. JAMA Oncol. 2018;4(12):1765-1772. 5. Tafreshi NK, et al. Molecules. 2019;24(23):4314.6. Hagemann UB, et al. Cancer Biother Radiopharm. 2020;35(7):497-510. α粒子靶向治疗是一种新兴的放射性核素疗法，可用于治疗多种肿瘤。它通过其骨靶向（镭-223）或通过将α放射性核素（如锕-225）与特定靶向部分相结合，选择性将发射α粒子的有效载荷递送到体内肿瘤。与β粒子相比，α粒子在短距离内沉积高强度电离辐射。这种放射性能量的局部沉积能够诱导肿瘤细胞出现不可逆的双链DNA断裂，进而导致细胞周期的停滞或细胞死亡。同时，由于能量传播的距离有限，因此能降低对邻近正常组织的损伤4-6。多菲戈®（氯化镭-223，镭-223）是首个获批证实可以延长合并骨转移的转移性去势抵抗性前列腺癌（mCRPC）男性患者生存，也是首个获批用于治疗前列腺癌的放射性核素治疗药物。拜耳作为一家跨国企业，在生命科学领域的健康与农业方面具有核心竞争力。公司致力于通过产品和服务，帮助人们克服全球人口不断增长和老龄化带来的重大挑战，造福人类和地球繁荣发展。拜耳致力于推动可持续发展并对业务产生积极影响。同时，集团还通过科技创新和业务增长来提升盈利能力并创造价值。在全球，拜耳品牌代表着可信、可靠及优质。在2023财年，拜耳的员工人数约为100,000名，销售额为476亿欧元。不计特殊项目的研究开发投入为58亿欧元。内容来源于网络，如有侵权，请联系删除。

AACR会议临床结果放射疗法

2024-04-25

·医药观澜

安斯泰来新药再获欧盟批准，将癌症扩散或死亡风险降低58%！

4月24日，安斯泰来（Astellas）宣布，欧盟委员会（EC）已批准enzalutamide（恩扎卢胺）的新适应症上市申请，作为单药治疗或与雄激素剥夺治疗（ADT）联合，用于不适合挽救性放疗的高风险生化复发性（BCR）、非转移性激素敏感性前列腺癌（nmHSPC）成年男性。这使得该产品的获批适应症覆盖复发性早期前列腺癌治疗。恩扎卢胺的这项适应症已经于2023年11月获美国FDA批准。在nmHSPC患者中，常规放射学方法无法检测到癌症扩散到身体远处的证据，并且癌症仍然对旨在降低睾丸激素水平的药物或手术治疗有反应。在接受过根治性前列腺切除术、放疗或两者兼而有之的男性患者中，估计有20%~40%的人会在10年内出现BCR。大约90%的高风险BCR患者会发展为转移性疾病，1/3的人会死于转移性前列腺癌。恩扎卢胺是一种雄激素受体（AR）信号抑制剂，它不但能够阻断雄激素与受体的结合，还能够抑制受体向细胞核内转移，以及雄激素受体与DNA的结合。因此它不仅仅是雄激素受体的拮抗剂，对雄激素信号通路也有抑制作用。恩扎卢胺此前已在欧盟获批治疗三种不同形态的晚期前列腺癌（非转移性和转移性去势抵抗性前列腺癌，及转移性去势敏感性前列腺癌）。本次获批治疗高危BCR nmHSPC，使得该产品的获批适应症覆盖复发性早期前列腺癌治疗。据安斯泰来新闻稿介绍，恩扎卢胺本次获批是基于在1068名高风险BCR nmHSPC患者中进行的3期EMBARK试验的结果，这些患者的前列腺特异性抗原（PSA）水平在9个月或更短的时间内翻了一倍（即高危BCR），PSA是前列腺癌活性的生物标志物。研究显示，与单独使用亮丙瑞林（leuprolide）治疗的患者相比，恩扎卢胺联合亮丙瑞林治疗的患者癌症扩散或死亡的几率降低了57.6%；单独接受恩扎卢胺治疗的参与者风险降低了36.9%。EMBARK试验的结果此前已经发表于《新英格兰医学杂志》（NEJM）。在中国，恩扎卢胺此前已获批用于治疗转移性去势抵抗性前列腺癌（mCRPC）和非转移性去势抵抗性前列腺癌（nmCRPC）患者。2023年9月，该药的新适应症上市申请获中国NMPA受理，用于治疗转移性激素敏感性前列腺癌（mHSPC）。参考资料：[1]Astellas’ XTANDITM (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting. Retrieved Apr 24， 2024, from https://www.astellas.com/en/news/29146 [2] 安可坦™️获欧盟委员会批准用于治疗男性患者转移性激素敏感性前列腺癌. Retrieved May 14, 2021, from https://mp.weixin.qq.com/s/3aAgUNZ-wr-gb0e1mKAj5w [3]Freedland SJ, et al. Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer. N Engl J Med. 2023;389:1453-146. 内容来源于网络，如有侵权，请联系删除。

上市批准临床结果申请上市放射疗法

2024-02-28

·医药观澜

默沙东联合开发，前列腺癌1类新药在中国启动3期临床

近日，中国药物临床试验登记与信息公示平台官网公示，默沙东（MSD）和Orion公司共同登记了两项MK-5684片针对转移性前列腺癌的国际多中心（含中国）3期临床研究。公开资料显示，MK-5684片是默沙东和Orion公司合作开发的一款口服非类固醇CYP11A1抑制剂。前列腺癌是常见的男性癌症之一。前列腺癌细胞的生长具有雄激素依赖性，故患者最初对雄激素剥夺治疗（ADT）敏感，而经持续ADT后仍然发生疾病进展的患者会发展为转移性去势抵抗性前列腺癌（mCRPC），这类患者的肿瘤已扩散至前列腺以外。研究表明，类固醇激素是驱动前列腺癌的关键因素之一，细胞色素P450 11A1（CYP11A1）是类固醇合成过程中的重要限速酶，靶向CYP11A1提供了抑制类固醇激素生产的有效手段。 MK-5684（又称ODM-208）是Orion公司发现和开发的一款潜在“first-in-class”CYP11A1特异性口服非类固醇抑制剂，被开发用于治疗前列腺癌等激素依赖性的癌症。通过抑制CYP11A1酶的活性，MK-5684可以抑制所有类固醇激素和可能激活雄激素受体（AR）信号通路的激素前体的产生。这与AR配体结合域（LBD）激活体细胞点突变的患者尤其相关，而体细胞点突变正是mCRPC对激素治疗的抵抗机制之一。 2022年7月，默沙东宣布和Orion公司达成全球研发合作协议，共同开发后者的在研疗法ODM-208和其它靶向CYP11A1的药物。双方将共同开发和商业化ODM-208，Orion公司将获得2.9亿美元前期付款。本次默沙东和Orion公司在中国启动的两项临床研究分别为：一项随机、开放性、3期研究，旨在既往使用1种新型内分泌治疗（NHA）期间或之后发生疾病进展的mCRPC患者中比较MK-5684与可选择的醋酸阿比特龙或恩扎卢胺的疗效；另一项为随机、开放性3期研究，旨在既往接受过NHA和紫杉烷类化疗的mCRPC患者中比较MK-5684与可选择的醋酸阿比特龙或恩扎卢胺的疗效。根据2024年1月发表在2024年美国临床肿瘤学会泌尿生殖系统肿瘤研讨会（ASCO GU）上的数据，MK-5684在伴有或不伴有AR-LBD突变的mCRPC患者中的2期临床研究取得积极结果。研究共纳入66例AR-LBD突变阳性和68例AR-LBD突变阴性患者，两组分别有53%和33.8%的患者接受过醋酸阿比特龙或恩扎卢胺治疗，63.6%和55.9%的患者接受过卡巴他赛治疗。结果显示，MK-5684可深度抑制雄激素合成，导致有AR-LBD突变和没有AR-LBD突变的患者中分别有55.6%和16.7%的患者出现PSA50（前列腺特异性抗原PSA减少≥50%）应答，69.8%和30.0%的患者出现PSA30应答。MK-5684耐受性良好，最常见的治疗相关不良事件与肾上腺抑制有关。根据研究人员得出的结论，MK-5684用于重度预处理的mCRPC患者显示出良好的抗肿瘤活性，PSA50反应在携带AR-LBD激活突变的患者中尤为常见。参考资料： [1]中国药物临床试验登记与信息公示平台官网.Retrieved Feb 26，2024, From http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml [2]MK-5684 (ODM-208), a CYP11A1 inhibitor, in patients with metastatic castration-resistant prostate cancer (mCRPC) with and without AR-LBD mutations: CYPIDES phase 2 results. Retrieved Jan 29，2024, From https://ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.159 内容来源于网络，如有侵权，请联系删除。