Lutrate (leuprorelin depot) / PharmaMar, Lubrizol - LARVOL DELTA

Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Participants With Recurrent Prostate Cancer (clinicaltrials.gov) - P2; N=310; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; Trial completion date: Feb 2021 ➔ Feb 2025; Trial primary completion date: Feb 2021 ➔ Feb 2025; N=200 ➔ 310

Clinical • Combination therapy • Enrollment change • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study (clinicaltrials.gov) - P3; N=810; Recruiting; Sponsor: ECOG-ACRIN Cancer Research Group; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Long-acting injectable PLGA/PLA depots for leuprolide acetate: successful translation from bench to clinic. (PubMed, Drug Deliv Transl Res) - "Long-acting depots for leuprolide acetate were among the first and most successful examples including Lupron Depot and ELIGARD. Studying these products is of great interest for researchers in both industry and academia. This will undoubtedly pave the road for the development of new as well as generic long-acting depots for a variety of drugs."

Journal • Review

New Agents and Evolving Strategies in Castration-Sensitive Prostate Cancer (CSPC) (Clinical Care Options) - "In the frontline management of patients with high‑risk, localized castration-sensitive prostate cancer (CSPC), biochemically recurrent CSPC, or metastatic CSPC (mCSPC), androgen-deprivation therapy (ADT) plays a critical role. ADT refers to lowering the testosterone level in a patient’s blood to castrate levels."

Online posting

Talazoparib With Androgen Deprivation Therapy and Abiraterone for the Treatment of Castration Sensitive Prostate Cancer (clinicaltrials.gov) - P2; N=70; Not yet recruiting; Sponsor: City of Hope Medical Center

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • AR

Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study (clinicaltrials.gov) - P2; N=0; Withdrawn; Sponsor: M.D. Anderson Cancer Center; N=160 ➔ 0; Trial completion date: Nov 2024 ➔ Jan 2021; Not yet recruiting ➔ Withdrawn; Trial primary completion date: Nov 2024 ➔ Jan 2021

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ALB

[VIRTUAL] Quality of life of patients with hormone-dependent advanced prostate cancer receiving palliative treatment with Leuprorelin depot injection (Lutrate®) – interim results from a non-interventional study in Germany (EMUC 2020) - "Conclusions The GNRH agonist leuprorelin depot injection maintains QoL in aPCA pts measured by the PORPUS-P score. It is an effective and well tolerated treatment option for pts with a hormone sensitive aPCa."

Clinical • HEOR • Observational data • Genito-urinary Cancer • Oncology • Palliative care • Prostate Cancer • Solid Tumor

[VIRTUAL] Inhibition of Critical DNA Dioxygenase Activity in IDH1/2 Mutant Myeloid Neoplasms (ASH 2020) - "Neomorphic mutations in IDH1/2 producing R-2-Hydroxyglutrate (R-2HG), are common in myeloid malignancies and in various solid cancers...To explore this hypothesis we conducted a series of in vitro experiments in different isogenic cell lines expressing either mutant or wild type IDH1 or IDH2, that were simultaneously mutant, wild type (WT) or knock down (KD) for TET2 (TF1-IDH2R140Q, K562-IDH1R132C both WT for TET2 gene, and K18-IDH1R132C TET2KD and SIGM5-IDH1R132C TET2MT, both with a doxycycline inducible promoter for mutant IDH1)...In summary, results shown here represent an important proof of concept that the increased inhibition of DNA dioxygenase activity, instead of being more leukemogenic, can be synthetically lethal. Our observations may have implications with regard to the therapy of IDH1/2 mutated neoplasms including AML and MDS"

Oncology • Solid Tumor • IDH1 • IDH2 • TET2

Androgen Deprivation With Oral Relugolix vs Leuprolide in Advanced Prostate Cancer: HERO Trial- Neal Shore (Urotoday) - "Contemporary Treatment Strategies For Androgen Deprivation Therapy In Prostate Cancer Lecture Presentation - Androgen Deprivation With Oral Relugolix vs Leuprolide in Advanced Prostate Cancer: HERO Trial - Neal Shore (12-minute lecture)."

Video

Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study (clinicaltrials.gov) - P2; N=160; Not yet recruiting; Sponsor: M.D. Anderson Cancer Center

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Using PET/CT Imaging (clinicaltrials.gov) - P3; N=804; Recruiting; Sponsor: ECOG-ACRIN Cancer Research Group; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

The Latest News and Updates in Prostate Cancer (Cure Today) - "While prostate cancer treatment can cause cardiovascular-related side effects, patients can take certain steps to mitigate those risks, according to Dr. Neal D. Shore....The risk for a major cardiovascular event was reduced by more than half in patients who received relugolix compared with the hormone-associated therapy leuprolide."

Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study (clinicaltrials.gov) - P3; N=810; Not yet recruiting; Sponsor: ECOG-ACRIN Cancer Research Group

Clinical • New P3 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Using PET/CT Imaging (clinicaltrials.gov) - P3; N=804; Not yet recruiting; Sponsor: ECOG-ACRIN Cancer Research Group

Clinical • New P3 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • KLK3

Identification of drought stress-responsive genes in rice (Oryza sativa) by meta-analysis of microarray data. (PubMed, J Genet) - "The lowest P value (P = 0.003756) among upregulated DEGs was observed for naringenin, 2-oxoglutrate 3-dioxygenase protein...These hub genes are stress responsive genes that may also be regarded as the marker genes for drought stress response. Our study reported a new set of hub genes (reference genes) that have potentially significant role in development of stress tolerant rice."

Journal • Retrospective data

"Krebs Cycle substrates Cricket -Citrate Club of -Cis Aconitate India - Iso citrate Ok- Ketoglutrate Service - Succinyl CoA Selection- Succinate For -Fumarate Men -Malate Only -Oxaloacetate" (@BharatJainRO)

Suppression of Oncometabolite 2-Hydroxyglutrate Produced by Mutant IDH1 Glioma with AGI-5198 Enhances the Efficacy of Radiotherapy and Immune Checkpoint Blockade Eliciting Immunological Memory (SNO 2019) - "Our results also demonstrate that antitumor immunity induced by 2HG inhibition is enhanced when combined with standard of care (temozolomide and radiation) and anti-PDL1 immune checkpoint blockade. In addition, when the long-term survivors (>90 days) were rechallenged with mIDH1 tumor cells in the contralateral hemisphere, without further treatment, all the mice remained tumor free, indicating the development of anti-glioma immunological memory. Collectively, these findings support the clinical testing of AGI-5198 as an adjuvant therapy and a novel immunotherapeutic strategy for treating patients with mIDH1 glioma."

Checkpoint inhibition • Clinical • IO Biomarker • PD(L)-1 Biomarker • IDH1 • TP53

Oncogenic R132 IDH1 Mutations Limit NADPH for De Novo Lipogenesis through (D)2-Hydroxyglutarate Production in Fibrosarcoma Sells. (PubMed, Cell Rep) - "IDH1-mutant cells exhibit increased dependence on exogenous lipid sources for in vitro growth, as removal of medium lipids slows growth more dramatically in IDH1-mutant cells compared with those expressing wild-type or enzymatically inactive alleles. NADPH regeneration may be limiting for lipogenesis and potentially redox homeostasis in IDH1-mutant cells, highlighting critical links between cellular biosynthesis and redox metabolism."

Journal

Challenging cases in extranodal lymphomas (ECP 2019) - "...Several cases illutrated the broad diagnostic spectrum of IgG4-related disease, including one case with a challenging differential diagnosis of monoclonal IgG4 positive plasmacytic proliferation and IgG4 positive MZL of the orbit arising in a background of IgG4-related disease...After thorough analysis, the case was signed out as reactive, and symptoms subsided after dexamethasone therapy...Finally, some cases illustrated the salient diagnostic features of EBV-related lymphoproliferations, highlighting a difficult differential diagnosis between EBV+ CHL, EBV+ mucocutaneous ulcer and EBV+ DLBCL. Three well-characterized cases demonstrated the occurrence of mass-forming lesions with amyloid, light chain or crystal-storing histiocytic deposits in the setting of lymphoplasmacytic lymphomas and MALT lymphomas."

Clinical • IO Biomarker

BUDGET IMPACT OF LEUPROLIDE ACETATE 3-MONTHLY DEPOT FORMULATIONS FOR THE MANAGEMENT OF PATIENTS WITH ADVANCED AND METASTATIC PROSTATE CANCER IN GREECE (ISPOR-EU 2019) - "OBJECTIVES : Luteinizing hormone-releasing hormone (LHRH) agonists represent the main treatment for the management of patients with advanced and metastatic prostate cancer (amPC). CONCLUSIONS : According to published data LHRH agonists have similar clinical efficacy and safety. The results of the model suggest that Lutrate Depot 22.5mg over the available 3M depot formulations could lead to considerable savings for EOPYY; consisting Lutrate Depot 22.5mg an alternative cost-saving treatment option for eligible amPC patients in Greece."

Clinical • HEOR

Role of HIF1α Regulatory Factors in Stem Cells. (PubMed, Int J Stem Cells) - "Recent research has unraveled the mechanistic details of HIF1α regulating processes, suggesting new strategies for regulating stem cells. This review summarizes recent experimental studies on the role of several regulatory factors (including calcium, 2-oxoglutarate-dependent dioxygenase, microtubule network, importin, and coactivators) in regulating HIF1α activity in stem cells."

Journal • Review