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

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 | Completed | Sponsor: NRG Oncology | Active, not recruiting ➔ Completed | Trial completion date: May 2026 ➔ Oct 2025 | Trial primary completion date: May 2026 ➔ Oct 2025

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

Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers (clinicaltrials.gov) - P2 | N=21 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Salivary Gland Cancer

Prostate Volume Reduction in Prostate Cancer: Predictive Factors after LHRHa Therapy (ASTRO 2025) - "Although ADT with LHRHa (Leupreline atrigel-Eligard) effectively suppresses PSA and testosterone levels, these reductions do not reliably predict significant prostate volume changes. Baseline prostate characteristics and individual patient factors may have a more substantial impact on volume changes. These findings underscore the need for further research to refine predictive models for prostatic volume reduction, particularly in radiotherapy planning, where accurate estimation of prostate size is crucial for defining the Planning Target Volume (PTV) and minimizing treatment-related toxicity."

Biomarker • 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 completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Sep 2025 ➔ Mar 2026

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

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

Enrollment open • Castration-Resistant Prostate Cancer • CNS Disorders • 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: Dec 2025 ➔ Jun 2026

Trial primary completion date • Genito-urinary 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 | Active, not recruiting | Sponsor: Weill Medical College of Cornell University | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

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

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 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Suspended ➔ Active, not recruiting

Enrollment closed • Ovarian Cancer

PROMPT: Postop Hypofractionated Radiation Therapy and LHRH in Patients With Prostate Cancer (clinicaltrials.gov) - P2 | N=77 | Recruiting | Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2023 ➔ Dec 2026

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

Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Icahn School of Medicine at Mount Sinai

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

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

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

OVELIA: Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer (clinicaltrials.gov) - P3 | N=250 | Active, not recruiting | Sponsor: Tolmar Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

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 completion date: May 2026 ➔ Aug 2026 | Trial primary completion date: May 2026 ➔ Aug 2026

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

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) | Initiation date: Apr 2025 ➔ Jul 2025

Trial initiation date • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer (clinicaltrials.gov) - P2 | N=29 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Mar 2025 ➔ Mar 2026

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

Real-life Evaluation of the Effect of ADT in Prostate Cancer Patients in Asia (READT Asia Study) (clinicaltrials.gov) - P=N/A | N=300 | Active, not recruiting | Sponsor: Chinese University of Hong Kong | Trial completion date: Dec 2025 ➔ Mar 2026

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

SHARP: Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer (clinicaltrials.gov) - P2 | N=25 | Active, not recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Apr 2025 ➔ Feb 2026 | Trial primary completion date: Apr 2025 ➔ Feb 2026

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

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