- |||||||||| 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) - Jul 5, 2023
P3, N=504, Active, not recruiting,
Japanese urologists appear to select appropriate primary androgen deprivation therapy based on patient background and tumour characteristics, with degarelix largely reserved for higher risk patients. Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jul 2023 --> Jul 2024
- |||||||||| Erleada (apalutamide) / J&J
Trial completion date, Trial primary completion date: c15-164: AASUR in High Risk Prostate Cancer (clinicaltrials.gov) - Jun 23, 2023
P2, N=64, Active, not recruiting,
The discovery of in vivo triptorelin (5-10) can possibly be used as supporting evidence of triptorelin misuse in athletes. Trial completion date: May 2023 --> May 2026 | Trial primary completion date: May 2023 --> May 2026
- |||||||||| Orgovyx (relugolix) / Intas, Gedeon Richter, Takeda, ASKA Pharma, Sumitomo Pharma, Pfizer
Trial completion date: REVELUTION: RElugolix VErsus LeUprolide Cardiac Trial (clinicaltrials.gov) - Jun 13, 2023
P4, N=94, Recruiting,
Six-month intramuscular LA depot demonstrated 48-week efficacy with a safety profile consistent with other GnRH agonist formulations. Trial completion date: Apr 2024 --> Apr 2025
- |||||||||| Clinical, Review, Journal: Drug Repurposing in Oncology: A Systematic Review of Randomized Controlled Clinical Trials. (Pubmed Central) - Jun 10, 2023
Major limitations of these clinical trials were the small sample size, the high clinical heterogeneity of the participants regarding the stage of the neoplastic disease, and the lack of accounting for multimorbidity and other baseline clinical characteristics. Drug repurposing possibilities in oncology must be carefully examined with well-designed trials, considering factors that could influence prognosis.
- |||||||||| Nubeqa (darolutamide) / Bayer, Orion Corp, Erleada (apalutamide) / J&J
MODULE 1: Current Management of Nonmetastatic Prostate Cancer (Hilton Chicago; Grand Ballroom (Level 2)) - May 26, 2023 - Abstract #ASCO2023ASCO_7055;
This activity is supported by educational grants from AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Lilly, Merck, and Sanofi. Current indications for androgen deprivation therapy (ADT) alone or in combination with radiation therapy after prostatectomy for localized prostate cancer Key findings from the STAMPEDE trial evaluating the efficacy and safety of abiraterone and prednisolone with or without enzalutamide and ADT for high-risk nonmetastatic prostate cancer; current and potential roles Design, eligibility criteria and major efficacy and safety results from the Phase III PRESTO trial evaluating the role of ADT intensification with apalutamide with or without abiraterone and prednisone for biochemically recurrent prostate cancer; potential implications Recently presented results from the Phase III EMBARK trial of enzalutamide/leuprolide and enzalutamide monotherapy for patients with high-risk, nonmetastatic, hormone-sensitive prostate cancer who experience a rising PSA after local therapy Published efficacy and safety findings from Phase III trials documenting the effectiveness of enzalutamide, apalutamide and darolutamide for nonmetastatic castration-resistant prostate cancer (CRPC) Clinical, biological and practical factors guiding the selection of enzalutamide, apalutamide and darolutamide for nonmetastatic CRPC
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas
Trial completion date: Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer (clinicaltrials.gov) - May 25, 2023
P2, N=19, Active, not recruiting,
Current indications for androgen deprivation therapy (ADT) alone or in combination with radiation therapy after prostatectomy for localized prostate cancer Key findings from the STAMPEDE trial evaluating the efficacy and safety of abiraterone and prednisolone with or without enzalutamide and ADT for high-risk nonmetastatic prostate cancer; current and potential roles Design, eligibility criteria and major efficacy and safety results from the Phase III PRESTO trial evaluating the role of ADT intensification with apalutamide with or without abiraterone and prednisone for biochemically recurrent prostate cancer; potential implications Recently presented results from the Phase III EMBARK trial of enzalutamide/leuprolide and enzalutamide monotherapy for patients with high-risk, nonmetastatic, hormone-sensitive prostate cancer who experience a rising PSA after local therapy Published efficacy and safety findings from Phase III trials documenting the effectiveness of enzalutamide, apalutamide and darolutamide for nonmetastatic castration-resistant prostate cancer (CRPC) Clinical, biological and practical factors guiding the selection of enzalutamide, apalutamide and darolutamide for nonmetastatic CRPC Trial completion date: Apr 2023 --> Apr 2024
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Journal: Clinical development of the GnRH agonist leuprolide acetate depot. (Pubmed Central) - May 24, 2023
Several long-acting depot formulations of leuprolide acetate (ranging from 1-month to 6-month intramuscular injections) have been successively developed for various suppressive treatments in men, women, and children, which are available in the United States and globally. This mini review aims to summarize the key clinical studies that led to regulatory approval of leuprolide acetate depot suspension for injection.
- |||||||||| Gnrh Agonist Therapy Induced Aggression in Children. a Case Report (Hall B Foyer, Exhibition Level Moscone South) - May 17, 2023 - Abstract #APA2023APA_1358;
Even though the use of GnRHa has shown to be effective in the treatment of psychosis, hallucinations, and emotional lability, it might actually be a catalyst for a host of emotional and psychiatric disturbances as seen in our patient. This highlights the need for more research to be done in this area and a collaborative health professional approach to better understand and treat various impacts of GnRHa therapy.
- |||||||||| Opdivo (nivolumab) / BMS
Enrollment open, Combination therapy, Metastases: Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov) - May 17, 2023
P2, N=60, Recruiting,
This highlights the need for more research to be done in this area and a collaborative health professional approach to better understand and treat various impacts of GnRHa therapy. Suspended --> Recruiting
- |||||||||| leuprolide acetate for depot suspension / Generic mfg., estradiol valerate / Generic mfg.
Hematospermia in Transgender Woman Revealing Occult Endometriosis (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_2457;
The incidence and prevalence of hematospermia in transgender women is unknown.Clinical Course: A 35-year-old transgender woman treated with estradiol valerate and leuprolide presents with persistent hematospermia and two years of intermittent hematuria. Hematospermia in transgender women on GAHT** may indicate occult M
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Supratherapeutic Estrogen Levels in Transgender Women Likely From Sublingual Estradiol (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_2441;
She denied estrogen pellets, implants, or consumption of additional E2 beyond 6mg daily, nor did she have visitors who provided supplemental hormone; however, she admitted that she does not swallow the E2 pills immediately.Endocrinology initiated intramuscular leuprolide to suppress her total testosterone production to the female range of 0-50 ng/dL, allow for decreased dosing of E2 to maintain female range estrogen levels, and minimize venous thromboembolism (VTE) risk given reduced patient mobility...Sublingual E2 also has a lower risk of VTE since it avoids first-pass metabolism. Future research should target alternative routes of estrogen therapy that may potentially be safer than current modalities.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg., hydrocortisone / Generic mfg., bicalutamide / Generic mfg.
GnRH agonist Induced Pituitary Apoplexy in a patient with Gonadotropinoma. (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_2001;
A week prior to starting Lupron therapy he was started on bicalutamide therapy...Hydrocortisone was tapered and stopped 6 weeks after transsphenoidal surgery...The majority of pituitary apoplexy develops in patients with previous undiagnosed pituitary adenomas. Should patients get central imaging to screen for pituitary macroadenoma before Lupron treatments to prevent this potentially life-threatening complication?
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Three Cases of Prepubertal Vaginal Bleeding (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_1754;
She was referred to our hospital because gonadal suppression therapy with leuprorelin didn't stop her PVB... In PVB cases we need to perform detailed assessments including careful history taking, physical examination and necessary testing considering a broad range of possible diseases.
- |||||||||| abiraterone acetate / Generic mfg.
Mineralocorticoid Excess Syndrome with Abiraterone (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_850;
There is minimal literature on abiraterone induced endocrine side effects. This case will increase awareness of these and help endocrinologists individualize management of adverse effects experienced by prostate cancer patients on abiraterone.
- |||||||||| dexamethasone / Generic mfg., leuprolide acetate for depot suspension / Generic mfg., hydrocortisone / Generic mfg.
A Successful Ovulation Induction and Embryo Generation in a Woman With P450-Oxidoreductase Deficiency From Mutation G539R, Which Preferentially Impairs 17,20-Lyase Activity (ENDOExpo) - May 11, 2023 - Abstract #ENDO2023ENDO_826;
Very few examples of pregnancy in women with POR deficiency have been reported, and we describe the first example of successful ovulation induction and embryo generation in a woman with POR deficiency caused by the G539R mutation, which preferentially impairs 17,20-lyase activity. The complex array of steroid excess and deficiencies, from both adrenal and ovarian origin, must be systematically managed during assisted reproduction treatment for these women.
- |||||||||| progesterone / Generic mfg., leuprolide acetate for depot suspension / Generic mfg.
The Effects of Sex Steroid Manipulation on Anhedonia in Women With a History of Postpartum Depression (Sapphire AB) - Apr 29, 2023 - Abstract #SOBP2023SOBP_825;
Active, not recruiting --> Completed Methods The hormone states of pregnancy and parturition were simulated in non-pregnant women with a history of PPD (n = 11) and healthy controls (n = 12) by inducing hypogonadism (via administration of gonadotropin-releasing hormone [GnRH] agonist, leuprolide acetate [Lupron]), adding back supraphysiologic doses of estradiol (E2) and progesterone (P4) for 2 weeks (
- |||||||||| leuprolide acetate for depot suspension / Generic mfg., leuprolide acetate injection / Generic mfg.
Characterizing the Neural Substrates of Irritability in Women: A 7T fMRI Study (Sapphire AB) - Apr 29, 2023 - Abstract #SOBP2023SOBP_473;
Results After hormone add-back, HS+ (vs. HS-) participants showed increased activation in the pregenual anterior cingulate cortex (k=374) and left putamen (k=143) during rigged feedback relative to positive feedback (TFCE, p<0.05, uncorrected). Conclusions Preliminary analyses suggest HS+ participants show increased activation in regions specific to mood regulation and reward processing during frustration after inducing hormone changes similar to the perinatal period.
- |||||||||| leuprolide acetate for depot suspension / Generic mfg.
Association of albumin and neutrophil-to-lymphocyte ratio with hormone-mediated depression in prostate cancer. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6970;
Conclusions Preliminary analyses suggest HS+ participants show increased activation in regions specific to mood regulation and reward processing during frustration after inducing hormone changes similar to the perinatal period. A sample of 26 PC patients on leuprolide (mean age 70 years; 13 Hispanic, 13 non-Hispanic) included 13 with mild depression (BDI
- |||||||||| enzalutamide capsule / Generic mfg., leuprolide acetate for depot suspension / Generic mfg.
PSMA PET findings in an (On Demand | Hall A; Poster Bd # 185) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1659;
P3
Background: The EMBARK trial is a phase 3, randomized, study evaluating use of enzalutamide with or without concomitant leuprolide in non-metastatic castrate sensitive prostate cancer patients. In this
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas
Trial initiation date: ARCH: Contributions to Hypertension With Androgen Deprivation Therapy (clinicaltrials.gov) - Apr 25, 2023
P4, N=228, Not yet recruiting,
Addressing this is important, because the acknowledgement of adverse effects is central to regulatory decisions and the protection of public health. Initiation date: Apr 2023 --> Jul 2023
- |||||||||| Xtandi (enzalutamide capsule) / Pfizer, Astellas
Enrollment open, Enrollment change, HEOR, Real-world evidence, Real-world, Metastases: Real World Evidence Study on Metastatic Prostate Cancer in the Pirkanmaa Hospital District in Finland (clinicaltrials.gov) - Apr 19, 2023
P=N/A, N=1, Recruiting,
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | N=15000 --> 1
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