InVivoMAb Anti-mouse PD-1 (10 mg/kg, clone J43, Bioxcell, West Lebanon, NH, USA), InVivoMAb anti-mouse CTLA-4 antibody (1 mg/kg, clone 9H10, Bioxcell), or InVivoMAb hamster anti-mouse IgG control antibodies (clone N/A, catalog # BE 0091, Bioxcell) were administered every other day for a total of four doses by intraperitoneal (i.p.) injection. The first dose was administered upon the larger tumors reaching 100 to 200 mm3, except for mice allocated to groups receiving androgen deprivation therapy in which case first dose was given 4 days after initiation of androgen deprivation therapy. When employed, androgen deprivation was induced by degarelix (Ferring Pharmaceuticals, Saint Prex, Switzerland), administered in single s.c. dose of 25 mg/kg upon the larger tumor graft reaching a volume of 300–400 mm3.
Degarelix
Manufactured by Ferring
Sourced in Switzerland, Sweden, United States
Degarelix is a synthetic peptide that acts as a gonadotropin-releasing hormone (GnRH) antagonist. It is used in the treatment of advanced prostate cancer.
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Lab products found in correlation
7 protocols using degarelix
1
Immune Checkpoint Inhibitor Therapy in Murine Tumor Model
2
M1 Macrophage Polarization and T-Cell Activation Assays
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Male C57BL/6NTac mice (9–12 weeks old) were euthanized by cervical dislocation. Bone marrow cells were isolated from femurs and tibias and cultured in RPMI medium supplemented with 10% fetal bovine serum, 1% penicillin/streptomycin, and 10% L‐cell conditioned medium for 7 days to generate bone marrow–derived macrophages (BMM) as previously described.18 BMMs were seeded at 1.5×105 cells/well in 48‐well plates and after 24 hours polarized towards an M1 phenotype with lipopolysaccharide (LPS, γ‐irradiated, L4391, Sigma‐Aldrich) at different concentrations: 1 ng/mL, 10 ng/mL, and 100 ng/mL. Leuprolide acetate (H4060, Bachem) and degarelix (Ferring Pharmaceuticals) were co‐incubated with the BMMs for 24 hours at a concentration of 10−6 mol/L. Cytokine secretion into the cell culture medium was subsequently analyzed using IL‐6, tumor necrosis factor‐α, and interferon‐γ ELISAs (Ready‐SET‐Go Mouse kits, eBioscience).
Splenocytes were isolated and seeded at 2×105 cells/well in 96‐well plates as previously described.19 Cells were activated with soluble anti‐mouse CD3ε antibody (BioLegend, clone: 145‐2C11) at different concentrations (0.3, 1.0, and 3.0 μg/mL) for 48 hours. Assessment of cell proliferation was made using the Quick Cell Proliferation Assay Kit (Abcam).
Splenocytes were isolated and seeded at 2×105 cells/well in 96‐well plates as previously described.
3
Prostate Cancer Imaging and Surgical Correlation
4
Comparing MACE Risks in Prostate Cancer ADT
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PRONOUNCE is a phase IIIb, multicenter, prospective, randomized, open, blinded endpoint trial designed to compare the occurrence of major adverse cardiovascular events (MACEs) in patients with advanced prostate cancer and pre-existing ASCVD who will receive either a GnRH antagonist (degarelix) or a GnRH agonist (leuprolide) as ADT for 12 months (25 (link)). The trial plans to enroll approximately 900 patients at approximately 100 sites in North America and Europe. The first patient was randomized in April 2016.
This trial is being conducted in compliance with the study protocol, the Declaration of Helsinki, and Good Clinical Practice, as defined by the International Conference on Harmonization. Before patient enrollment, written informed consent is obtained from each patient, and approval is obtained from appropriate institutional review boards and ethics committees for participating sites. The steering and operations committees, which include academic members and sponsor representatives, oversee the medical, scientific, and operational conduct of the study. The PRONOUNCE trial is supported by the manufacturer of degarelix, Ferring Pharmaceuticals (Parsippany, New Jersey).
This trial is being conducted in compliance with the study protocol, the Declaration of Helsinki, and Good Clinical Practice, as defined by the International Conference on Harmonization. Before patient enrollment, written informed consent is obtained from each patient, and approval is obtained from appropriate institutional review boards and ethics committees for participating sites. The steering and operations committees, which include academic members and sponsor representatives, oversee the medical, scientific, and operational conduct of the study. The PRONOUNCE trial is supported by the manufacturer of degarelix, Ferring Pharmaceuticals (Parsippany, New Jersey).
5
Testosterone Depletion and Restoration
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Thirty subjects were submitted to a testosterone depletion by the use of gonadotropin-releasing hormone antagonist (GnRHa) (subcutaneous injection, 240 mg, Degarelix, Ferring Pharmaceuticals, Sweden) and, after three weeks, to an androgen supplementation by use of testosterone undecanoate (intramuscular injection, 1000 mg, Nebido, Bayer Pharmaceuticals, Germany)20 (link).
Therefore, blood samples were collected three times: (i) before TD, corresponding to testosterone and gonadotropins' baseline levels (Basal group); (ii) before the androgen supplementation, relating to low testosterone and gonadotropins' levels (Low group); (iii) two weeks after TS, corresponding to Testosterone restored samples (Restored group) (Fig.1 ).
The naturally recover of testosterone was not applied in this study in order to evaluate what happens in an individual with low gonadotropins and normal testosterone. We assumed that this is a way to study the changes correlated just with testosterone fluctuations. Furthermore, it is important to consider that the testosterone axis recovery period varies significantly among males. Therefore, we believe that this variance would interfere with the last time point metabolic analysis.
Therefore, blood samples were collected three times: (i) before TD, corresponding to testosterone and gonadotropins' baseline levels (Basal group); (ii) before the androgen supplementation, relating to low testosterone and gonadotropins' levels (Low group); (iii) two weeks after TS, corresponding to Testosterone restored samples (Restored group) (Fig.
The naturally recover of testosterone was not applied in this study in order to evaluate what happens in an individual with low gonadotropins and normal testosterone. We assumed that this is a way to study the changes correlated just with testosterone fluctuations. Furthermore, it is important to consider that the testosterone axis recovery period varies significantly among males. Therefore, we believe that this variance would interfere with the last time point metabolic analysis.
6
MRI Evaluation of Prostate Cancer Patients
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The Ethics Committee of the Hospital District of Southwest Finland has approved this study. All patients have given written informed consent. The MR examinations were performed between March 2013 and May 2014. The study enrolled 72 consecutive patients with histologically confirmed PCa who were scheduled for robotic assisted laparoscopic prostatectomy.
Two of the patients had the Gonadotropin releasing hormone antagonist (Degarelix, Ferring Pharmaceuticals) started just before the MR examination. The rest of the patients had no prostate-related hormonal, surgical, or radiotherapy treatment before or during imaging.
A subset of the data has already been used in previous studies. DWI data sets (12 b values, 0–2000 s/mm2) of 48 patients were used for evaluating mathematical models of DWI [9 (link), 10 (link), 12 (link)], while T2 of 37 patients were used in feasibility evaluation of relaxation along fictitious field and continuous wave T1ρ imaging of PCa [10 (link), 23 (link)].
Two of the patients had the Gonadotropin releasing hormone antagonist (Degarelix, Ferring Pharmaceuticals) started just before the MR examination. The rest of the patients had no prostate-related hormonal, surgical, or radiotherapy treatment before or during imaging.
A subset of the data has already been used in previous studies. DWI data sets (12 b values, 0–2000 s/mm2) of 48 patients were used for evaluating mathematical models of DWI [9 (link), 10 (link), 12 (link)], while T2 of 37 patients were used in feasibility evaluation of relaxation along fictitious field and continuous wave T1ρ imaging of PCa [10 (link), 23 (link)].
7
Subcutaneous Degarelix Therapy for Tumors
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Mice were treated subcutaneously with either degarelix (25 mg/kg) (Ferring Pharmaceuticals, Parsippany, New Jersey, USA) or a vehicle sham (PBS) treatment every 28 days starting when the tumor volume reached 0.1–0.2 cm3.
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