leuprolide acetate for depot suspension / Generic mfg. 
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  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg.
    Journal:  Efficient aqueous remote loading of peptides in poly(lactic-co-glycolic acid). (Pubmed Central) -  Jun 10, 2022   
    Leuprolide encapsulated by this approach in low-molecular-weight PLGA 75/25 microspheres slowly and continuously released peptide for over 56 days in vitro and suppressed testosterone production in rats in an equivalent manner as the 1-month Lupron Depot®...In certain cases, in vitro and in vivo performance of remote-loaded PLGA microspheres exceeded that relative to marketed products. Remote absorption encapsulation further removes the need for a critical organic solvent removal step after encapsulation, allowing for simple and cost-effective sterilization of the drug-free microspheres before encapsulation of the peptide.
  • ||||||||||  Reimbursement, Journal:  Hospital-Administered Cancer Therapy Prices for Patients With Private Health Insurance. (Pubmed Central) -  Jun 9, 2022   
    Most NCI-designated cancer centers did not publicly disclose payer-specific prices for cancer therapies as required by federal regulation. The findings of this cross-sectional study suggest that, to reduce the financial burden of cancer treatment for patients, institution of public policies to discourage or prevent excessive hospital price markups on parenteral chemotherapeutics might be beneficial.
  • ||||||||||  Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
    Enrollment open:  REVELUTION: RElugolix VErsus LeUprolide Cardiac Trial (clinicaltrials.gov) -  Jun 8, 2022   
    P4,  N=90, Recruiting, 
    The findings of this cross-sectional study suggest that, to reduce the financial burden of cancer treatment for patients, institution of public policies to discourage or prevent excessive hospital price markups on parenteral chemotherapeutics might be beneficial. Not yet recruiting --> Recruiting
  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg.
    Preclinical, Journal:  Estropause, Sex Hormones and Metal Homeostasis in the Mouse Brain. (Pubmed Central) -  Jun 4, 2022   
    To assess whether age-related changes in hypothalamic-pituitary-gonadal (HPG) hormones might be involved in modulating brain metal ion homeostasis, we treated 7.5-month intact, sham-ovariecomized and ovariectomized C57B6SJL mice with vehicle or leuprolide acetate (for 9-months) to differentiate between whether sex steroids or gonadotropins might modulate brain metal ion concentrations...This study demonstrates that sex hormones do not markedly alter brain metal ion homeostasis, unlike previously reported studies of circulating metal ion homeostasis. The role of gonadotropins in regulating metal ion homeostasis does however warrant further study.
  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg.
    Journal:  Hydroxyl Group-Targeted Conjugate and Its Self-Assembled Nanoparticle of Peptide Drug: Effect of Degree of Saturation of Fatty Acids and Modification of Physicochemical Properties. (Pubmed Central) -  May 29, 2022   
    To conjugate different degree of saturation of C18 fatty acids (stearic acid, oleic acid, and linoleic acid) with the hydroxyl groups of leuprolide acetate (LEU acetate) and to investigate the controlled release and enhanced permeability through self-assembled nanoparticles (L18FNs)...While the permeability of LSNs was not significantly enhanced due to higher particle size after nanonization, LONs and LLNs increased 1.56 and 1.85 times in permeation, respectively, compared to LEU. Utilization of different degree of saturation of fatty acids to conjugate a peptide drug could provide pharmaceutical versatility via self-assembly and modification of physicochemical properties.
  • ||||||||||  Erleada (apalutamide) / J&J, Firmagon (degarelix) / Astellas, Ferring
    Trial completion date, Trial primary completion date:  PRESTO: A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer (clinicaltrials.gov) -  May 11, 2022   
    P3,  N=504, Recruiting, 
    Adjuvant hormonal treatment in such patients may have a role in preventing disease recurrence. Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2023 --> Jan 2024
  • ||||||||||  Firmagon (degarelix) / Astellas, Ferring, Orgovyx (relugolix) / Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
    Journal:  THE CARDIOVASCULAR EFFECTS OF GNRH ANTAGONISTS IN MEN WITH PROSTATE CANCER. (Pubmed Central) -  May 11, 2022   
    Trial completion date: Jan 2023 --> Jan 2024 | Trial primary completion date: Jan 2023 --> Jan 2024 There is consistent but methodologically limited data to suggest that GnRH antagonists-a relatively new class of androgen deprivation therapy for prostate cancer-cause significantly less cardiovascular adverse effects than the more frequently used GnRH agonists.
  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg.
    Enrollment change, Trial withdrawal:  BASH-PC: Bariatric Arterial Embolization for Men Starting Hormones for Prostate Cancer (clinicaltrials.gov) -  May 2, 2022   
    P2,  N=0, Withdrawn, 
    Postoperative pregnancy can reduce the recurrence rate after operation, and patients with fertility requirements should be encouraged to make activ preparations for postoperative pregnancy. N=20 --> 0 | Suspended --> Withdrawn
  • ||||||||||  Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
    The adoption of relugolix for treatment of prostate cancer (PCa) in a large community medical oncology practice. () -  Apr 28, 2022 - Abstract #ASCO2022ASCO_4023;    
    The HERO trial showed that relugolix, a newer oral therapy, is associated with lower rates of cardiovascular events compared to leuprolide. While having at least one cardiovascular risk factor is a consideration for patients to either start with or switch to relugolix, the large majority of our patients still received first-line therapy with leuprolide.
  • ||||||||||  enzalutamide capsule / Generic mfg., leuprolide acetate for depot suspension / Generic mfg., abiraterone acetate / Generic mfg.
    Feasibility of a novel wrist-worn thermal device for management of vasomotor symptoms in patients with prostate cancer. (Available On Demand; 250) -  Apr 28, 2022 - Abstract #ASCO2022ASCO_3675;    
    P=N/A
    Results of this study support the feasibility of use of the thermal device for management of bothersome hot flashes in PCa survivors. Future randomized controlled studies are warranted to evaluate patient reported outcomes related to frequency and severity of VMS, sleep quality, fatigue, and overall QOL, in addition to defining the potential utility of the Embr thermal device in PCa survivors experiencing VMS.
  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg., tamoxifen / Generic mfg.
    Adherence to different adjuvant endocrine therapies in HR+ HER2-breast cancer and its relation to real-world progression rates. () -  Apr 28, 2022 - Abstract #ASCO2022ASCO_3362;    
    While adherence is important for positive outcomes for all regimens, some regimens appear to be more sensitive to adherence changes with respect to RWD-ORR. Further analysis including disease risk factors is needed to explain ORR - PDC relationship.TAM- tamoxifen; AI aromatase inhibitors.*GLM with AI, Tamoxifen as reference treatment group.†p<0.05
  • ||||||||||  sunitinib / Generic mfg.
    Trial primary completion date:  Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy (clinicaltrials.gov) -  Apr 27, 2022   
    P2,  N=64, Active, not recruiting, 
    However, larger studies are needed to elucidate the optimal E2 target on OFS and clinical implications of incomplete E2 suppression on ultrasensitive assays. Trial primary completion date: Dec 2021 --> Dec 2022
  • ||||||||||  Nubeqa (darolutamide) / Bayer, Orion Corp, Erleada (apalutamide) / J&J
    Journal:  Hormonal Therapy for Prostate Cancer. (Pubmed Central) -  Apr 26, 2022   
    The purpose of this review is to provide an assessment of hormonal therapies for the various clinical states of prostate cancer. The advancement of today's standard of care will require an accounting of an individual's androgen physiology that also has recently recognized germline determinants of peripheral androgen metabolism, which include HSD3B1 inheritance.
  • ||||||||||  leuprolide acetate for depot suspension / Generic mfg.
    Journal:  Development of Self-Administered Formulation to Improve the Bioavailability of Leuprorelin Acetate. (Pubmed Central) -  Apr 24, 2022   
    Notably, higher C and faster T were obtained with the MGE-containing formulation, and the BA increased with increasing MGE content in the formulation, suggesting that LA migration into the systemic circulation and its stability might be enhanced by MGE. These results may support the development of self-administered formulations of peptide drugs as well as nucleic acids, which are easily metabolized in the skin.
  • ||||||||||  cabazitaxel / Generic mfg.
    Trial completion, Trial completion date, Trial primary completion date:  ACDC-RP: Anti-Androgens and Cabazitaxel in Defining Complete Response in Prostatectomy (ACDC Trial) (clinicaltrials.gov) -  Apr 15, 2022   
    P2,  N=76, Completed, 
    However, positive attitudes among them were similar. Active, not recruiting --> Completed | Trial completion date: Mar 2022 --> Jul 2021 | Trial primary completion date: Dec 2021 --> May 2021