- |||||||||| leuprorelin depot / Generic mfg., bicalutamide / Generic mfg.
An Unusual Case of Rectal Bleeding (Shoreline Exhibit Hall) - Sep 8, 2021 - Abstract #ACG2021ACG_2291;
B: MRI of pelvis with an enlarged prostate measuring 6.7cm x 6.2cm x 8.9cm. The gland abuts the anterior rectal wall with loss of the anterior serosal surface.
- |||||||||| leuprorelin depot / Generic mfg., bicalutamide / Generic mfg.
A Case of Metastatic Prostate Cancer Masquerading as Radiation Proctitis on Colonoscopy (Shoreline Exhibit Hall) - Sep 8, 2021 - Abstract #ACG2021ACG_924;
He was previously treated with radiation therapy 20 years ago followed by brachytherapy and Bicalutamide, and was on biannual Leuprolide at the time of exam...Patient was subsequently started on Enzalutamide which led to a decline in PSA...Center: Medium power view of hematoxylin and eosin stained section showing neoplastic cells expanding the lamina propria. Right: The neoplastic cells are positive for pancytokeratin (AE1/AE3), NKX3.1 and PSAP, confirming metastatic carcinoma consistent with prostate primary.
- |||||||||| leuprorelin depot / Generic mfg., bicalutamide / Generic mfg.
Clinical, Journal: Failure to achieve castrate level of serum testosterone during luteinizing hormone-releasing hormone agonist therapy in a patient with prostate cancer. (Pubmed Central) - Sep 2, 2021
Due to liver dysfunction, antiandrogens, both bicalutamide and flutamide, were stopped...Leuprorelin acetate was replaced by goserelin acetate...Androgen deprivation therapy is the standard treatment for patients with advanced prostate cancer and luteinizing hormone-releasing hormone aims to suppress serum testosterone to castrate range. We recommend assessing the serum testosterone levels during luteinizing hormone-releasing hormone agonist therapy for monitoring treatment efficacy and verifying progression when the PSA level increases.
- |||||||||| leuprorelin depot / Generic mfg.
[VIRTUAL] Diagnostic Dilemma in a Patient with Central Precocious Puberty: Ovarian Steroid Cell Tumor () - Aug 27, 2021 - Abstract #ESPE2021ESPE_1015;
GnRH therapy (leuprolide acetate therapy 3,75 mg/28 days) was initiated due to centrally rapidly progressing puberty and early menarche...Estrogensecreting ovarian masses may not be detected by USG when they are still small in size. Radiological imaging may be repeated, especially in rapidly progressing puberty cases showing clinical and hormonal progression despite treatment.
- |||||||||| leuprorelin depot / Generic mfg.
[VIRTUAL] Sterile Abscess Formation with Two Different GnRH Analogues: Three Case Reports () - Aug 27, 2021 - Abstract #ESPE2021ESPE_960;
Enantone appeared to have been effective in the treatment of CPP. Although SA is a rare side effect, it is very important as it causes patients to be left untreated.In our cases, the active substance of the drug accumulates in the localization of SA and cannot be absorbed, so it cannot enter the systemic circulation.Therefore, puberty cannot be suppressed.Also, often leaving a scar is annoying for patients and their families.We suggest that if a dose increase is required, SA may develop.For this, we recommend the injection site check.If SA develops, we recommend discontinuing the treatment and not insisting on treatment.
- |||||||||| leuprorelin depot / Generic mfg.
[VIRTUAL] Gonadotropin Flare with Different Depot GnRH Agonists: Comparative Analysis. () - Aug 27, 2021 - Abstract #ESPE2021ESPE_957;
Leuprolide 45 mg, long-acting, biannual administration did not induce a significant higher gonadotropin flare as compared to the monthly Triptorelin 3.75 mg. This result suggests that there should be no concerns regarding flare when using Leuprolide 45 mg to initiate treatment of CPP in girls.
- |||||||||| leuprorelin depot / Generic mfg.
[VIRTUAL] Query By Telarquia: Has there been an increase due to the SARS-COV19 pandemic? () - Aug 27, 2021 - Abstract #ESPE2021ESPE_569;
first consultation, difference between chronological age and bone age, sex hormone values (FSH,LH and estradiol) in the first analysis, if a functional test was performed to study the gonadal axis (Procrin) and result of the same, abdominal ultrasound, if they had received stopping treatment, if they had had contact with disruptors, if they had gained at least 3kg in weight in the last 6 months and the final diagnosis given.Comparing both years, in 2020 there were 28% more first consultations by early thelarchies than, in 2019 (p: 0.0001 average comparison)...But we can also observe that in 2020 there are more children who consult with a higher BMI and with an increase in weight gain in the last 6 months. This increase in weight could suggest a trigger effect due to an increase in fat mass and a greater number of advanced puberty.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Enrollment open, Trial completion date, Trial primary completion date: Brown Adipose Tissue Activity in Pre- and Postmenopausal Women (clinicaltrials.gov) - Aug 24, 2021
P=N/A, N=72, Recruiting,
This increase in weight could suggest a trigger effect due to an increase in fat mass and a greater number of advanced puberty. Suspended --> Recruiting | Trial completion date: Aug 2021 --> Aug 2022 | Trial primary completion date: Aug 2021 --> Aug 2022
- |||||||||| Orgovyx (relugolix) / Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
Clinical, Review, Journal: Relugolix: a novel androgen deprivation therapy for management of patients with advanced prostate cancer. (Pubmed Central) - Aug 20, 2021
Taken together, the data indicate that relugolix may mitigate some of the cardiovascular concerns surrounding ADT and has the potential to become a new standard of care for men with prostate cancer. In summary, relugolix represents a novel and recently available prostate cancer management strategy, incorporating the mechanistic advantages of GnRH antagonists and the potential benefits of oral administration.
- |||||||||| Firmagon (degarelix) / Astellas, Ferring
Trial suspension, Monotherapy: High-Dose Brachytherapy in Treating Patients With Prostate Cancer (clinicaltrials.gov) - Aug 18, 2021
P1/2, N=163, Suspended,
In summary, relugolix represents a novel and recently available prostate cancer management strategy, incorporating the mechanistic advantages of GnRH antagonists and the potential benefits of oral administration. Recruiting --> Suspended
- |||||||||| Piqray (alpelisib) / Novartis
Trial completion date, Metastases: BYLieve: Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (clinicaltrials.gov) - Aug 18, 2021
P2, N=382, Active, not recruiting,
Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Apr 2021 --> Apr 2022 Trial completion date: Jul 2022 --> Jan 2023
- |||||||||| leuprorelin depot / Generic mfg.
Journal: Hydrogen-Bonded Films for Zero-Order Release of Leuprolide. (Pubmed Central) - Aug 12, 2021
Initially, an increase in the level of serum testosterone is induced by the released drug, followed by testosterone suppression to a constant level below the castrate level, which could be maintained as long as a constant serum drug level is maintained. Since the new drug carriers avoid an initial burst release of the drug and maintain a constant serum drug level and hence a constant serum testosterone level below the castrate level, these carriers are highly promising for androgen deprivation therapy.
- |||||||||| leuprorelin depot / Generic mfg.
Journal: Non-Adaptive MR-Guided Radiotherapy for Prostate SBRT: Less Time, Equal Results. (Pubmed Central) - Aug 8, 2021
By avoiding the extra time required for plan adaptation, MRgRT without daily adaptation allows for successful prostate SBRT with manageable toxicity. We continue to reserve our limited adaptive treatment slots for preoperative pancreatic and ultra-central lung SBRT patients, which require time-intensive respiratory gating and adaptive planning.
- |||||||||| leuprorelin depot / Generic mfg.
Journal: 'Flexible-acceptor' General Solubility Equation for 'beyond Rule of 5' Drugs. (Pubmed Central) - Aug 4, 2021
The mp coefficient ( 0.007) remains practically constant, near the traditional value (-0.01) for most molecules, which suggests that the small-to-large molecule continuum is mainly solvation responsive, apparently with only minor changes in the crystal lattice contributions. For a test set of 32 large molecules (e.g., cyclosporine A, gramicidin A, leuprolide, nafarelin, oxytocin, vancomycin - mostly natural-product derived therapeutics used in infectious/viral diseases, in immunosuppression, and in oncology) the modified equation predicted the intrinsic solubility with a root-mean-square-error of 1.10 log unit, compared to 3.0 by the traditional GSE, and 1.07 by RFR.
- |||||||||| letrozole / Generic mfg., leuprolide acetate for depot suspension / Generic mfg., everolimus / Generic mfg.
Trial completion, Enrollment change, Trial completion date, Trial primary completion date: Study of (1) Everolimus, (2) Estrogen Deprivation Therapy (EDT) With Leuprolide + Letrozole and (3) Everolimus + EDT in Patients With Unresectable Fibrolamellar Hepatocellular Carcinoma (FLL-HCC) (clinicaltrials.gov) - Jul 23, 2021
P2, N=28, Completed,
A delay in initiating long-acting GnRH agonist after oocyte retrieval in patients at high risk for developing OHSS should be considered. Active, not recruiting --> Completed | N=84 --> 28 | Trial completion date: Jul 2022 --> Jul 2021 | Trial primary completion date: Jul 2022 --> Jul 2021
- |||||||||| leuprorelin depot / Generic mfg.
[VIRTUAL] Puberty () - Jul 19, 2021 - Abstract #ESPE2021ESPE_221;
Large cohort studies bring more information regarding secular trends in central precocious puberty, premature thelarche or adrenarche but also gynecomastia. This presentation will also addresse new discoveries regarding the effect of prenatal stress on pubertal timing and the results of the first phase 3 study of a subcutaneous 6-month leuprolide acetate.
- |||||||||| Piqray (alpelisib) / Novartis
Enrollment open, Metastases: BYLieve: Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments (clinicaltrials.gov) - Jul 7, 2021
P2, N=390, Recruiting,
Not yet recruiting --> Recruiting Active, not recruiting --> Recruiting
- |||||||||| Journal: From micro to nano: evolution and impact of drug delivery in treating disease. (Pubmed Central) - Jul 4, 2021
Very recently, the first siRNA lipid nanoparticle medicine, Patisiran (Onpattro®), was approved for treating hereditary transthyretin-mediated amyloidosis. In this inspirational note, we will highlight the technological evolution of drug delivery from micro- to nano-, citing some of the approved medicines demonstrating the significant impact of the drug delivery field in treating many diseases.
- |||||||||| Orgovyx (relugolix) / Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Dainippon
P3 data, Journal: Phase 3 HERO Trial Finds Relugolix to Be Superior to Leuprolide in Prostate Cancer. (Pubmed Central) - Jul 3, 2021
P3
In this inspirational note, we will highlight the technological evolution of drug delivery from micro- to nano-, citing some of the approved medicines demonstrating the significant impact of the drug delivery field in treating many diseases. Results from the phase 3 HERO trial(NCT03085095), presented during the 2020 American Society of Clinical Oncology Virtual Scientific Program, indicated that relugolix (Relumina) demonstrated superiority over leuprolide (Lupron) in sustained testosterone suppression through 48 weeks, fast testosterone recovery after discontinuation, and a 50% reduction in major adverse cardiovascular events (MACE) in patients with advanced prostate cancer.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Enrollment open, Metastases: BSV_LEUPR_18_05: Leuprolide Acetate 3.75 mg Depot Injection for Patients With Advanced Prostate Cancer (clinicaltrials.gov) - Jul 1, 2021
P3, N=168, Recruiting,
Results from the phase 3 HERO trial(NCT03085095), presented during the 2020 American Society of Clinical Oncology Virtual Scientific Program, indicated that relugolix (Relumina) demonstrated superiority over leuprolide (Lupron) in sustained testosterone suppression through 48 weeks, fast testosterone recovery after discontinuation, and a 50% reduction in major adverse cardiovascular events (MACE) in patients with advanced prostate cancer. Not yet recruiting --> Recruiting
- |||||||||| Lupron Depot (leuprorelin depot) / AbbVie, Takeda
Journal: Effect of Manufacturing Variables and Raw Materials on the Composition-Equivalent PLGA Microspheres for 1-Month Controlled Release of Leuprolide. (Pubmed Central) - Jun 8, 2021
The 1-month Lupron Depot (LD) is a 75/25 acid-capped poly(lactic-co-glycolic acid) (PLGA) microsphere product encapsulating water-soluble leuprolide acetate with no generic products available in the U.S. Composition-equivalent PLGA microsphere formulations to the LD as a function of raw material and manufacturing variables were developed by using the solvent evaporation encapsulation method...The in vitro release kinetics of the formulations were highly similar to the LD in a zero-order manner after ~20% initial burst release, indicating a critical role of the composition on peptide release in this formulation. The characterization of composition-equivalent formulations described here could be useful for further development of generic leuprolide PLGA microspheres, and for guiding decisions on the influence of process variables on product physicochemical attributes and release performance.
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