leuprolide acetate for depot suspension / Generic mfg. - LARVOL DELTA

Coronary Artery Plaque Progression After Androgen Deprivation Therapy in Men with Prostate Cancer: A Randomized Controlled Trial Comparing Relugolix Versus Leuprolide (SUO 2025) - P2 | "ADT for prostate cancer is associated with accelerated coronary atherosclerosis within 12 months and is higher with GnRH-agonist leuprolide compared with GnRH-antagonist relugolix."

Clinical • Acute Coronary Syndrome • Atherosclerosis • Coronary Artery Disease • Genito-urinary Cancer • Myocardial Infarction • Oncology • Prostate Cancer • Solid Tumor

Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: Xiao X. Wei, MD | Trial completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • ABRAXAS1 • BRCA1 • BRIP1 • CD8 • CDK12 • CHEK2 • GEN1 • MLH1 • MSH2 • MSH6 • MSI • NBN • PD-L1 • RAD51C • RAD51D

Results of the Randomized Phase 3 AFU-GETUG-20 Trial Evaluating Adjuvant Leuprorelin Acetate After Radical Prostatectomy in Men with High-risk Localized Prostate Cancer. (PubMed, Eur Urol Oncol) - "Leuprorelin treatment immediately after RP in high-risk nonmetastatic PCa patients with an undetectable PSA level does not improve survival, but increases adverse events, leading to poorer quality of life compared with observation."

Journal • P3 data • CNS Disorders • Fatigue • Genito-urinary Cancer • Mental Retardation • Oncology • Pain • Prostate Cancer • Psychiatry • Solid Tumor

CASPAR: A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy (clinicaltrials.gov) - P3 | N=61 | Active, not recruiting | Sponsor: Alliance for Clinical Trials in Oncology | Trial primary completion date: Mar 2026 ➔ Mar 2027

Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Challenges in analyzing real-world evidence: analysis of androgen deprivation therapy use for prostate cancer in the REASSURE study. (PubMed, ESMO Real World Data Digit Oncol) - "Study objectives included patient demographics, clinical characteristics, and ADT treatment duration by treatment received [goserelin or other ADTs (leuprorelin, degarelix, or triptorelin)]. While some patterns of ADT use in REASSURE were consistent with recommendations from clinical practice guidelines, there were also some inconsistencies. Findings from REASSURE highlighted the importance of considering potential differences in health care systems, population coverage, and patient data collection between regions, as well as incorporating data from multiple sources to capture data from more diverse patient populations, thus improving the quality of outputs from real-world studies."

HEOR • Journal • Real-world evidence • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

EMBARK: Overall survival with enzalutamide in biochemically recurrent prostate cancer (ESMO 2025) - P3 | "Background The phase 3 EMBARK trial (NCT02319837) showed significant improvements in metastasis-free survival (MFS) and secondary efficacy endpoints with enzalutamide plus leuprolide (enza combo) and enzalutamide monotherapy (enza mono) vs leuprolide alone (LA). ‖ P <0.0499 was statistically significant. ¶ Nominal P -value."

Clinical • Late-breaking abstract • Genito-urinary Cancer • Oncology • Prostate Cancer

Enzalutamide with or without leuprolide in patients with high-risk biochemically recurrent prostate cancer: EMBARK post hoc analysis by age. (PubMed, Eur J Cancer) - P3 | "Clinically meaningful improvements in MFS were observed following enzalutamide ± leuprolide in patients with hrBCR regardless of age. TRSAEs were more common in older patients but were low regardless of age. These findings should be interpreted in light of small subgroup sizes."

Journal • Retrospective data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • Urethral Cancer • Urology

The effect of tinzaparin sodium and leuprolide acetate in an experimental mouse model of endometriosis: The rol of the WNT/beta-catenin pathway. (PubMed, Turk J Obstet Gynecol) - "WNT2 and HIF1a immunostaining revealed greater reductions in score in the tnz7d group compared with controls and other treatment arms, but these differences were not statistically significant. Further investigation is warranted to determine how tinzaparin sodium and leuprolide acetate modulate the WNT/β-catenin axis for the management of endometriosis."

Journal • Preclinical • Endometriosis • Gynecology • Inflammation • Women's Health • HIF1A • WNT2

Impact of Relugolix Versus Leuprolide on the Quality of Life of Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study. (PubMed, Eur Urol) - "Oral relugolix is a therapeutic option with similar patient-reported HRQOL to leuprolide, providing an oral option for androgen deprivation therapy associated with a more rapid testosterone reduction."

HEOR • Journal • Metastases • P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A multi-center, prospective, observational study of patients with prostate cancer being treated with relugolix: OPTYX. (ASCO-GU 2023) - P=N/A | "In the phase 3 HERO trial, relugolix maintained suppression of testosterone to castration levels in 96.7% of men from Day 29 to 48 weeks, with superiority to leuprolide acetate. In addition to assessing routine clinical care and disease progression, patient reported outcomes will be assessed with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) for HRQoL and Simplified Medication Adherence Questionnaire (SMAQ) for adherence at 3 and 6 months then every 6 months. Clinical trial information: NCT05467176."

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

The effectiveness of relugolix compared with leuprorelin for preoperative therapy before laparoscopic myomectomy: a randomized controlled noninferiority study (MyLacR study). (PubMed, Fertil Steril) - "Patients will benefit from preoperative therapy with the gonadotropin-releasing hormone agonist leuprorelin or the gonadotropin-releasing hormone antagonist relugolix in reducing blood loss. However, relugolix was associated with a more rapid recovery from the postoperative hypoestrogenic state than was leuprorelin."

Head-to-Head • Journal • Endocrine Cancer • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Efficacy and Safety of Radiotherapy Plus Relugolix in Men With Localized or Advanced Prostate Cancer. (PubMed, JAMA Oncol) - "This multicenter post hoc analysis of patients with localized and advanced prostate cancer receiving radiotherapy in 2 randomized clinical trials (a phase 2 trial of relugolix vs degarelix, and a subset of the phase 3 HERO trial of relugolix vs leuprolide acetate) included men who were receiving radiotherapy and short-term (24 weeks) ADT (n = 103) from 2014 to 2015 and men receiving radiotherapy and longer-term (48 weeks) ADT (n = 157) from 2017 to 2019...Patients receiving longer-term ADT received relugolix, 120 mg, orally once daily (360-mg loading dose) or leuprolide acetate injections every 12 weeks for 48 weeks, with up to 90 days of follow-up...The results of these 2 randomized clinical trials suggest that relugolix rapidly achieves sustained castration in patients with localized and advanced prostate cancer receiving radiotherapy. No new safety concerns were identified when relugolix was used with radiotherapy."

Clinical • Journal • Metastases • Atrial Fibrillation • Cardiovascular • Genito-urinary Cancer • Hypertension • Oncology • Pain • Prostate Cancer • Solid Tumor

A Phase I Clinical Trial Evaluating the Safety and Dosing of Relugolix with Novel Hormonal Therapy for the Treatment of Advanced Prostate Cancer. (PubMed, Target Oncol) - P1 | "Combination therapy of relugolix and abiraterone or apalutamide was associated with a favorable safety and tolerability profile consistent with the known profiles of the individual medications. Castration levels of testosterone were maintained after transitioning to relugolix from other ADTs."

Journal • Metastases • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Initial Results of a Phase 2 Trial of Stereotactic Body Radiation Therapy, Hormone/Androgen Deprivation Therapy and Radium 223 Dichloride for Oligometastatic Castrate Sensitive Prostate Cancer (SHARP) (ASTRO 2024) - P2 | "Materials/ ADT (degarelix [n=4], relugolix [n=2], or leuprolide [n=19]) was administered starting at least 4 weeks prior to SBRT and continued for 36 weeks. Ra-223 combined with SBRT to oligometastases and 36 weeks ADT in mCSPC is well-tolerated and results in favorable OS and PFS compared to historical controls. Longer follow-up is necessary to assess if the early use of Ra-223 delays development of new bone metastases."

Metastases • P2 data • Anemia • Cardiovascular • Gastroenterology • Genito-urinary Cancer • Hematological Disorders • Hepatology • Hypertension • Leukopenia • Metastatic Castration-Resistant Prostate Cancer • Musculoskeletal Diseases • Neutropenia • Oncology • Prostate Cancer • Solid Tumor • CXCL8 • TNFA

Pooled Analysis of the SOLAR and SATURN Clinical Trials Comparing Progression of Synchronous Versus Metachronous Prostate-specific Membrane Antigen-defined Oligometastatic Prostate Cancer Following Systemic and Tumor-directed Therapy. (PubMed, Eur Urol Oncol) - P2 | "All patients received 6 mo of intensified systemic therapy (leuprolide, abiraterone acetate with prednisone, and apalutamide) and stereotactic body radiotherapy to oligometastases. Among 50 patients (24 synchronous and 26 metachronous), the synchronous omCSPC group had a significantly higher PSA response rate (83% vs 50%; p = 0.018) and significantly longer PFS and eugonadal PFS (p < 0.05). The metachronous subgroup with prior ADT had worse outcomes, suggesting increasing resistance with repeated systemic therapy."

Journal • Retrospective data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Long-term Safety, Efficacy, and PROs: Phase 3 Study of Leuprolide Acetate 6-month IM Depot in Central Precocious Puberty. (PubMed, J Endocr Soc) - P3 | "Six-month LA IM depot for 144 weeks demonstrated a sustained inhibition of the GnRH axis in children with CPP with an acceptable safety profile. Health-related quality of life was maintained, and PAH improved during ∼3 years of treatment."

Journal • P3 data • Endocrine Disorders

A randomized trial of neoadjuvant leuprorelin, darolutamide, or both prior to radical prostatectomy for intermediate- or high-risk prostate cancer. (ASCO-GU 2026) - P4 | "Clinical Trial Registry Number: NCT06627530. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

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

Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial. (PubMed, Breast Cancer Res Treat) - P3 | "The clinical benefit and overall response rates in males were consistent with the overall population. This analysis demonstrates the safety and efficacy of ribociclib in a close-to-real-world setting, supporting the use of RIB + LET in male patients with HR+, HER2- ABC."

Journal • P3 data • Breast Cancer • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Male Breast Cancer • Neutropenia • Oncology • Solid Tumor • HER-2

Study on the Improvement Effect of Probiotics on Perimenopausal Syndrome in Women with Infertility Induced by Leuprolide (ChiCTR) - P=N/A | N=100 | Not yet recruiting | Sponsor: Reproductive Hospital Affiliated to Jiangxi University of Traditional Chinese Medicine; Reproductive Hospital Affiliated to Jiangxi University of Trad

New trial • Infertility • Sexual Disorders

Long-term trends in androgen-directed therapy in advanced prostate cancer: a 29-year national analysis. (PubMed, Int Urol Nephrol) - "Australia has transitioned from predominately LHRH-based therapy to widespread use of ARPIs. Health-system structures enabling timely clinical access appears pivotal to the rapid and equitable diffusion of high-value androgen-targeted therapies."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A phase II study of androgen receptor inhibition by darolutamide in combination with leuprolide acetate and exemestane in recurrent adult-type ovarian granulosa cell tumor (SGO 2026) - No abstract available

Clinical • Combination therapy • P2 data • Oncology • Ovarian Cancer

Effects of Enzalutamide on the Sexual Activity of Patients with Biochemically Recurrent Prostate Cancer: A Post Hoc Analysis of Patient-reported Outcomes in the EMBARK Study. (PubMed, Eur Urol) - "Longitudinally, no clinically meaningful changes for any SA-related item were observed from baseline to week 205 in any group. SA-related HRQoL preservation seems to be better with enzalutamide monotherapy than with leuprolide alone."

Journal • Retrospective data • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer. (PubMed, N Engl J Med) - P3 | "In patients with prostate cancer with high-risk biochemical recurrence, enzalutamide plus leuprolide was superior to leuprolide alone with respect to metastasis-free survival; enzalutamide monotherapy was also superior to leuprolide alone. The safety profile of enzalutamide was consistent with that shown in previous clinical studies, with no apparent detrimental effect on quality of life. (Funded by Pfizer and Astellas Pharma; EMBARK ClinicalTrials.gov number, NCT02319837.)."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Prostate-specific antigen dynamics from the phase 3 EMBARK trial: A post hoc analysis (AUA 2024) - P3 | "and Astellas Pharma Inc INTRODUCTION AND OBJECTIVE: In the EMBARK trial, enzalutamide + leuprolide (enza combo) and enza monotherapy (mono) showed statistically superior and clinically meaningful improvements in metastasis-free survival (MFS) vs placebo + leuprolide (alone) while maintaining quality of life in patients (pts) with high-risk biochemically recurrent (BCR) prostate cancer. In pts with high-risk BCR, more pts who were treated with enza combo and enza mono reached undetectable PSA, they reached undetectable PSA sooner, had tx suspended at week 37, and achieved undetectable PSA following tx re-initiation vs leuprolide alone."

P3 data • Retrospective data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

EMBARK post hoc analysis of sexual activity (SA) patient-reported outcome (PRO) measures. (ASCO-GU 2024) - P3 | "Background: In the phase 3 EMBARK trial (NCT02319837), enzalutamide (ENZ) + leuprolide (L) and ENZ monotherapy (mono) delayed metastasis-free survival (MFS) vs placebo (P) + L without impairing global health-related quality of life (HRQoL) in high-risk biochemically recurrent (BCR) nonmetastatic hormone-sensitive prostate cancer (nmHSPC) (PSA doubling time ≤9 months). This post hoc item-level analysis of the EMBARK trial confirmed that SA was better preserved with ENZ mono vs P + L in terms of interest, activity, satisfaction, and maintaining erection. Further, the SA PROs were similar between ENZ + L and P + L, implying there is no further SA burden when adding ENZ to androgen-deprivation therapy. Clinical trial information: NCT02319837."

Clinical • Patient reported outcomes • Retrospective data • Genito-urinary Cancer • Prostate Cancer