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

Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Icahn School of Medicine at Mount Sinai | Not yet recruiting ➔ Recruiting | Initiation date: Jun 2025 ➔ Mar 2026

Enrollment open • Trial initiation date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • CTLA4

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

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

Enrollment open • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Baptist Health South Florida

New P2 trial • Genito-urinary 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 | Recruiting | Sponsor: Ontario Clinical Oncology Group (OCOG) | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) (clinicaltrials.gov) - P3 | N=1068 | Active, not recruiting | Sponsor: Pfizer | Trial primary completion date: Aug 2022 ➔ Dec 2022

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

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) (clinicaltrials.gov) - P3 | N=1860 | Not yet recruiting | Sponsor: Medivation, Inc.

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

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

Phase classification • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) (clinicaltrials.gov) - P3 | N=1860 | Recruiting | Sponsor: Medivation, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Monotherapy • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) (clinicaltrials.gov) - P3 | N=1068 | Active, not recruiting | Sponsor: Pfizer | N=1860 ➔ 1068 | Trial completion date: Jun 2024 ➔ Jul 2023 | Trial primary completion date: Mar 2021 ➔ Jul 2020

Enrollment change • Monotherapy • Trial completion date • Trial primary completion date • Hormone Sensitive Prostate Cancer • Prostate Adenocarcinoma • Prostate Cancer

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) (clinicaltrials.gov) - P3 | N=1860 | Active, not recruiting | Sponsor: Pfizer | Recruiting ➔ Active, not recruiting

Enrollment closed • Monotherapy • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) (clinicaltrials.gov) - P3 | N=1860 | Recruiting | Sponsor: Pfizer | Trial primary completion date: Dec 2020 ➔ Aug 2021

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

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) (clinicaltrials.gov) - P3 | N=1068 | Active, not recruiting | Sponsor: Pfizer | Trial completion date: Jul 2023 ➔ Sep 2026 | Trial primary completion date: Jul 2020 ➔ Sep 2023

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

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) (clinicaltrials.gov) - P3 | N=1068 | Active, not recruiting | Sponsor: Pfizer | Trial primary completion date: Sep 2023 ➔ Aug 2022

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

Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) (clinicaltrials.gov) - P3 | N=1860 | Recruiting | Sponsor: Pfizer | Trial primary completion date: Sep 2021 ➔ Mar 2021

Monotherapy • Trial primary completion date • Hormone Sensitive Prostate Cancer • Prostate Adenocarcinoma • Prostate Cancer

AFU-GETUG-20: Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients. (clinicaltrials.gov) - P3 | N=700 | Active, not recruiting | Sponsor: UNICANCER

New P3 trial • Oncology

AFU-GETUG-20: Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients. (clinicaltrials.gov) - P3 | N=700 | Recruiting | Sponsor: UNICANCER | Active, not recruiting ➔ Recruiting | Trial primary completion date: Jan 2015 ➔ Jan 2018

Enrollment open • Trial primary completion date • Oncology

OLIGOPELVIS: Salvage Radiotherapy Combined With Hormonotherapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer (clinicaltrials.gov) - P2 | N=74 | Completed | Sponsor: Institut Cancerologie de l'Ouest | Active, not recruiting ➔ Completed

Monotherapy • Trial completion • 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 2027 ➔ Jan 2028 | Trial primary completion date: Jan 2026 ➔ Jan 2027

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

Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer (clinicaltrials.gov) - P2; N=28; Recruiting; Sponsor: Jonsson Comprehensive Cancer Center; Trial completion date: Jul 2023 ➔ Jan 2023; Trial primary completion date: Jul 2022 ➔ Jan 2022

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

APEX: Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Jan 2026 ➔ Jan 2027

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