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Phase II Randomized Trial of Recurrence-directed Therapy (RDT) with or Without Androgen-Deprivation Therapy (ADT) in Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC).

The goal of this study is to determine whether the addition of Androgen Deprivation Therapy (ADT) utilizing the study drug ELIGARD® to Recurrence- Directed Therapy (RDT) improves progression-free survival (PFS) compared to RDT alone in patients with early radio-recurrent oligo-metastatic castrate / hormone sensitive prostate cancer (romCSPC). Participants will be assessed at standard of care clinic visits every 3 months. The follow-up period is 36 months.

开始日期2025-04-15

申办/合作机构

Ontario Clinical Oncology Group

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100 项与 Tolmar Pharmaceuticals Canada, Inc 相关的临床结果

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0 项与 Tolmar Pharmaceuticals Canada, Inc 相关的专利（医药）

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项与 Tolmar Pharmaceuticals Canada, Inc 相关的文献（医药）

2025-02-10·Journal of Clinical Oncology

Real-world evidence for factors associated with development of castration-resistant prostate cancer (CRPC).

作者: Lacuna, Kristine Peregrino ; Boldt-Houle, Deborah M ; Ryan, Charles J. ; Yoo, Lena ; Szmukier, Zuzanna

92Background: Androgen deprivation therapy (ADT) is foundational for advanced prostate cancer (PCa); luteinizing hormone-releasing hormone (LHRH) agonists and gonadotropin-releasing hormone (GnRH) antagonists are widely used. ~20% of PCa patients on LHRH analogs develop castration-resistant prostate cancer (CRPC) within 3 years. We evaluated factors associated with CRPC onset and time to CRPC onset for agonists vs. antagonist using real-world dataset. Methods: Data were collected from an EMR database purchased from Decision Resources Group. Analysis set included PCa patients who received ≥1 ADT 1991-2020 and excluded those who received both LHRH agonist and a GnRH antagonist and/or developed CRPC on the same day/before ADT initiation. CRPC onset date was defined as the earlier of 2 options: CRPC diagnosis or first CRPC therapy (standard of care treatments e.g., androgen pathway inhibitors, immunotherapy, chemotherapy, radiotherapy). Associations between CRPC and each available factor were evaluated using MV Cox regression. Time to CRPC onset was assessed for agonists vs. antagonist. Results: 41,379 patients were analyzed. Factors associated with MV HR >1.4, p<0.001 were oncology setting, metastatic disease, absence of diabetes, and no statin use (Table 1). Antagonist use had an adjusted HR of 1.4 (95% CI 1.06-1.85, p=0.02). Median time to CRPC onset after ADT initiation is 10.9 months for antagonist (n=238) vs. 17.3 months for agonists (n=5,231). Conclusions: Treatment-related (oncology setting; antagonist use) and comorbidity factors (older age, no diabetes, no statin use) were associated with CRPC onset. Oncology setting and antagonist use may reflect practice patterns in higher risk individuals. The association between diabetes and CRPC risk is under further evaluation e.g., whether antecedent diabetes therapies confer protection. Hazard ratio (95% CI) and P-value of CRPC for top 10 significant factors 1 in multivariable analysis. Multivariable (n=9,554) 2,3FactorsHR (95% CI)P-valueOncology vs Urology (Setting)3.04 (2.56-3.59)<0.001W vs W/o Metastasis (Baseline)2.20 (1.58-3.05)<0.001 W/o vs W Diabetes 41.45 (1.22-1.73)<0.001 W/o vs W Statin 41.43 (1.25-1.63)<0.001Antagonist vs Agonist1.40 (1.06-1.85)0.02 W/o vs W Hypertension 4 (HTN) 1.17 (1.01-1.36)0.041Decreasing ADT Exposure per Year1.09 (1.05-1.13)<0.001Increasing Age per Year (Older vs Younger)1.02 (1.02-1.03)<0.001

1 Significant for multivariable analysis. 2 Excluded patients with CRPC on the same day/before ADT Start. 3 Excluded patients with both agonist and antagonist use; without BMI, PSA, and age data; non-white/black race; with unknown urology/oncology or with both urology/oncology setting. 4 Has taken statins/hypertension/diabetes medication or diagnosed with hypertension/diabetes disease.

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100 项与 Tolmar Pharmaceuticals Canada, Inc 相关的转化医学

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