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 completion date: Dec 2026 ➔ Mar 2027 | Trial primary completion date: Sep 2026 ➔ Dec 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 LUCINDA Trial: LeUprolide Plus Cholinesterase Inhibition to Reduce Neurological Decline in Alzheimer's (clinicaltrials.gov) - P2 | N=86 | Completed | Sponsor: Weill Medical College of Cornell University | Active, not recruiting ➔ Completed | N=180 ➔ 86

Enrollment change • Trial completion • Alzheimer's Disease • CNS Disorders • Cognitive Disorders

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

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 | Completed ➔ Active, not recruiting | Trial completion date: Oct 2025 ➔ Oct 2030

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

Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study (clinicaltrials.gov) - P3 | N=250 | Enrolling by invitation | Sponsor: Tolmar Inc. | Trial completion date: Jun 2028 ➔ Mar 2030 | Trial primary completion date: Jun 2028 ➔ Mar 2030

Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial (clinicaltrials.gov) - P2 | N=202 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • 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=3 | Active, not recruiting | Sponsor: Roswell Park Cancer Institute | Recruiting ➔ Active, not recruiting | N=14 ➔ 3 | Trial completion date: Dec 2029 ➔ Mar 2028 | Trial primary completion date: Dec 2029 ➔ Mar 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • CNS Disorders • Genito-urinary Cancer • Oncology • 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 | Recruiting | Sponsor: Baptist Health South Florida | Trial completion date: Oct 2030 ➔ Feb 2031 | Initiation date: Apr 2026 ➔ Jul 2026 | Trial primary completion date: Oct 2029 ➔ Feb 2030

Trial completion date • Trial initiation date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • 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: Sep 2026 ➔ Jun 2026

Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • 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=17 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | N=37 ➔ 17 | Trial primary completion date: May 2027 ➔ Feb 2026

Enrollment change • Trial primary completion date • Oncology • Ovarian Cancer

NEST: Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty (clinicaltrials.gov) - P4 | N=50 | Active, not recruiting | Sponsor: HanAll BioPharma Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Endocrine Disorders

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

Trial completion • Castration-Resistant Prostate Cancer • 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 | Recruiting | Sponsor: Icahn School of Medicine at Mount Sinai | Trial primary completion date: Dec 2026 ➔ Dec 2027

Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • CTLA4

Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial (clinicaltrials.gov) - P2 | N=202 | Not yet recruiting | Sponsor: Mayo Clinic

New P2 trial • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Adenocarcinoma • 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: Jun 2026 ➔ Sep 2026

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

Long-Term Real-World Evidence of Clinical Suppression with 6-Month Subcutaneous Leuprolide Acetate in Children with Central Precocious Puberty (ENDO 2026) - "SC-LA demonstrated sustained clinical suppression, including suppression of HV to the prepubertal range and stabilization of pubertal progression as reflected by maintained or regressed Tanner stage. These findings complement and extend the phase 3 pivotal trial results by providing supportive long-term real-world evidence for the effectiveness of SC-LA in children treated for CPP."

Clinical • HEOR • Real-world • Real-world evidence • Endocrine Disorders

ETCTN 10553: 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) | Trial completion date: Apr 2027 ➔ Nov 2026 | Trial primary completion date: Apr 2027 ➔ Nov 2026

Trial completion date • Trial primary completion date • Oncology • Salivary Gland Cancer

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: Dec 2027 ➔ Dec 2029 | Trial primary completion date: Dec 2026 ➔ Dec 2029

Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • CNS Disorders • Genito-urinary Cancer • Oncology • 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 | Recruiting | Sponsor: Baptist Health South Florida | Not yet recruiting ➔ Recruiting

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

CTO21042GZA: Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER): A Two-part Phase 2/3 Trial (clinicaltrialsregister.eu) - P2/3 | N=493 | Recruiting | Sponsor: Ziekenhuis Aan De Stroom

New P2/3 trial • Genito-urinary Cancer • Oncology • 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 2026 ➔ Feb 2027

Trial completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • 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: Feb 2026 ➔ Jan 2027

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

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 | Not yet recruiting ➔ Active, not recruiting

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

CTOR18001GZA: A phase II, randomized, open-label study comparing salvage radiotherapy in combination with 6 months of androgen-deprivation therapy (ADT) with LHRH agonist or antagonist versus anti-androgen therapy (AAT) with apalutamide in patients with biochemical progression after radical prostatectomy (clinicaltrialsregister.eu) - P1/2 | N=202 | Active, not recruiting | Sponsor: Ziekenhuis Aan De Stroom | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • 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 | 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