Eligard (leuprolide acetate) / Tolmar, Sanofi, Daewoong Pharma, Recordati - LARVOL DELTA

GnRHa 45 mg SC LA Positively Impacts Predicted Adult Height Depending on the Degree of Bone Age Advancement (ENDO 2025) - "45 mg SC LA increases PAH by ~3-5 cm in girls over 48 weeks treatment across a range of BA/CA categories. Girls with BA/CA ≥1.4 showed benefit from treatment by week 24 which persisted until at least week 48. For girls with BA/CA ≤1.4, longer treatment may be needed to observe PAH increase."

Clinical • Endocrine Disorders

The COSMYC Trial (COmbined Suppression of MYC) (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

New P2 trial • Castration-Resistant Prostate Cancer • CNS Disorders • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

NEST: Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: HanAll BioPharma Co., Ltd.

New P4 trial • Endocrine Disorders

ADOPT: Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy (clinicaltrials.gov) - P3 | N=280 | Active, not recruiting | Sponsor: University Medical Center Groningen | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2024 ➔ Dec 2027 | Trial primary completion date: Dec 2024 ➔ Oct 2027

Enrollment closed • Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

The LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Weill Medical College of Cornell University | Trial primary completion date: Dec 2025 ➔ May 2026

Trial primary completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

ImmunoADAPT: Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov) - P2 | N=33 | Active, not recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Mar 2025 ➔ Sep 2025

Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Immune Modulation • Immunology • Oncology • Solid Tumor • ER

PCS-XII: Optimal Duration of Hormonal Therapy for Unfavorable Intermediate-risk Prostate Cancer Patients: 6 Versus 12 Months. (clinicaltrials.gov) - P3 | N=400 | Not yet recruiting | Sponsor: Charles LeMoyne Hospital

New P3 trial • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy (clinicaltrials.gov) - P2 | N=118 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Dec 2024 ➔ Jul 2025 | Trial primary completion date: May 2023 ➔ Apr 2025

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

NCI-2018-01856: Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer (clinicaltrials.gov) - P2 | N=310 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Feb 2025 ➔ Feb 2027 | Trial primary completion date: Feb 2025 ➔ Feb 2027

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

SATURN: Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer (clinicaltrials.gov) - P2 | N=28 | Active, not recruiting | Sponsor: Jonsson Comprehensive Cancer Center | Trial completion date: Jan 2026 ➔ Jan 2027 | Trial primary completion date: Jan 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • CTCs

Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study (clinicaltrials.gov) - P3 | N=27 | Active, not recruiting | Sponsor: ECOG-ACRIN Cancer Research Group | Trial primary completion date: Jun 2025 ➔ Dec 2025

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

Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study (clinicaltrials.gov) - P3 | N=27 | Active, not recruiting | Sponsor: ECOG-ACRIN Cancer Research Group | Trial primary completion date: May 2028 ➔ Jun 2025

Surgery • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

The Predictive Value of TMPRSS2-ERG Fusion in High Risk Prostate Cancer Patient (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: Sir Mortimer B. Davis - Jewish General Hospital | N=65 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial completion date • Trial withdrawal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ERG • TMPRSS2

Management of Castration-Resistant Prostate Cancer with Oligometastases (clinicaltrials.gov) - P2/3 | N=102 | Active, not recruiting | Sponsor: Sir Mortimer B. Davis - Jewish General Hospital | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2025 ➔ Apr 2027

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

RATIONAL-PCS: Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC) (clinicaltrials.gov) - P2 | N=162 | Not yet recruiting | Sponsor: Ontario Clinical Oncology Group (OCOG)

Metastases • New P2 trial • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

ImmunoADAPT: Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer (clinicaltrials.gov) - P2 | N=33 | Active, not recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Jul 2024 ➔ Mar 2025

Trial primary completion date • Breast Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Immune Modulation • Immunology • Oncology • Solid Tumor • ER

Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: Ohio State University Comprehensive Cancer Center | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2024 ➔ Aug 2024

Enrollment open • Trial initiation date • Cardiovascular • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=14 | Recruiting | Sponsor: Roswell Park Cancer Institute | Trial completion date: Apr 2027 ➔ Oct 2027 | Trial primary completion date: Apr 2026 ➔ Oct 2026

Metastases • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • CNS Disorders • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer (clinicaltrials.gov) - P1/2 | N=9 | Active, not recruiting | Sponsor: Praful Ravi, MB BCHir, MRCP | N=93 ➔ 9

Enrollment change • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

OVELIA: Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer (clinicaltrials.gov) - P3 | N=250 | Recruiting | Sponsor: Tolmar Inc. | Trial completion date: Apr 2025 ➔ Apr 2026 | Trial primary completion date: Apr 2025 ➔ Apr 2026

Combination therapy • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer (clinicaltrials.gov) - P1/2 | N=93 | Active, not recruiting | Sponsor: Praful Ravi, MB BCHir, MRCP | Trial primary completion date: Jul 2024 ➔ Jul 2025

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

Neoadjuvant And Adjuvant Abiraterone Acetate + Apalutamide Prostate Cancer Undergoing Prostatectomy (clinicaltrials.gov) - P2 | N=118 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Trial completion date: Jun 2024 ➔ Dec 2024

Trial completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

NRG-GU002: Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery (clinicaltrials.gov) - P2/3 | N=612 | Active, not recruiting | Sponsor: NRG Oncology | N=175 ➔ 612 | Trial completion date: May 2031 ➔ May 2026

Enrollment change • Surgery • Trial completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A RANDOMIZED NON-COMPARATIVE PHASE II MULTICENTRIC TRIAL ON SHORT TERM DAROLUTAMIDE (ODM-201) CONCOMITANT TO RADIATION THERAPY FOR PATIENTS WITH INTERMEDIATE UNFAVORABLE RISK PROSTATE CANCER DAROLUTAMIDE (ODM-201) CONCOMITANT A LA RADIOTHERAPIE CHEZ LES PATIENTS PRESENTANT UN CANCER DE LA PROSTATE A RISQUE INTERMEDIAIRE DEFAVORABLE : UNE ETUDE MULTICENTRIQUE RANDOMISEE NON-COMPARATIVE DE PHASE II (clinicaltrialsregister.eu) - P2 | N=62 | Ongoing | Sponsor: Institut Bergonié

New P2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Achieving Random LH <1 IU/L Correlated with Achieving Peak LH <4 IU/L with 6-Month Subcutaneous Leuprolide Acetate (ENDO 2024) - "92% of patients on SC LA who achieved random LH <1.0 IU/L also achieved a leuprolide-stimulated peak LH <4.0 IU/L, suggesting a correlation between the two thresholds. Therefore, these combined data demonstrated successful pubertal suppression by SC LA. Clinicians should consider multiple markers of pubertal suppression when reviewing efficacy as a single value may not provide a complete picture.Funding: Tolmar, Inc.Unless otherwise noted, all abstracts presented at ENDO must not be released to the press or the public until the date and time of presentation."

Endocrine Disorders