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

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

Multicriteria decision making attributes and estimation of physicochemical properties of kidney cancer drugs via topological descriptors. (PubMed, PLoS One) - "Secondly, we examine the attributes of nineteen drugs casodex, eligard, mitoxanrone, rubraca, and zoladex, etc and among others, using linear QSPR model. This leads towards new opportunities to paved the way for drug discovery and the formation of efficient and suitable treatment options in therapeutic targeting. We also employed multicriteria decision making techniques like COPRAS and PROMETHEE-II for ranking of said disease treatment drugs and physicochemical characteristics."

Journal • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

NRG-GY033: Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors (clinicaltrials.gov) - P2 | N=37 | Suspended | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Suspended

Combination therapy • Trial suspension • Oncology • Ovarian Cancer • ER • PGR

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 | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Castration-Resistant Prostate Cancer • CNS Disorders • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • 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: Feb 2025 ➔ Dec 2025

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

Phase 3 Study Shows XTANDI (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer (PRNewswire) - P3 | N=1,068 | EMBARK (NCT02319837) | Sponsor: Pfizer | "Pfizer...and Astellas Pharma...announced positive topline results from the Phase 3 EMBARK trial evaluating XTANDI® (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer with high-risk biochemical recurrence (BCR)....The study met its primary endpoint with a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for patients treated with XTANDI plus leuprolide versus placebo plus leuprolide....The study also met a key secondary endpoint with a statistically significant and clinically meaningful improvement in MFS for patients treated with XTANDI monotherapy versus placebo plus leuprolide....Detailed results from EMBARK will be presented at a future medical meeting. These data will also be discussed with regulatory authorities, including the U.S. FDA, to support a potential regulatory submission for XTANDI in this indication."

P3 data: top line • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor