Viadur (leuprorelin implant) / J&J, Bayer - LARVOL DELTA

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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