Yonsa (abiraterone acetate) / Churchill Pharma, Sun Pharma - LARVOL DELTA

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

Apalutamide-induced prostate-specific antigen response and its association with clinical outcomes in metastatic castration sensitive prostate cancer (Review). (PubMed, Mol Clin Oncol) - "Comparative analyses demonstrated that PSA90 or ultralow PSA thresholds were reached sooner and in more patients with apalutamide than with abiraterone or enzalutamide, resulting in lower mortality at 24 months in real-world data. It is concluded that rapid, deep PSA suppression under apalutamide + ADT is associated with improved clinical outcomes in mCSPC. PSA response metrics are proposed to be considered as early surrogate endpoints for guiding treatment decisions but are recommended to be used in conjunction with imaging and clinical assessment."

Clinical data • Journal • Review • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

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

Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer. (clinicaltrials.gov) - P2 | N=192 | Recruiting | Sponsor: Sun Pharmaceutical Industries Limited | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2026 ➔ Dec 2027 | Trial primary completion date: Jun 2025 ➔ Dec 2027

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

The Impact of a Generic Alternative on Medicare Part D Spending for Abiraterone (AUA 2026) - " Medicare Part D data (years 2013-2023) was analyzed for all abiraterone formulations (Zytiga, Yonsa, and generic). Generic abiraterone has largely supplanted its branded counterpart. This is temporally associated with dramatic reductions in Medicare spending and per-beneficiary cost despite an increase in the number of patients receiving abiraterone. These benefits were not seen with enzalutamide, which does not yet have a generic alternative."

Medicare • Reimbursement • US reimbursement • Genito-urinary Cancer • Oral Cancer • Prostate Cancer • Solid Tumor

OMAHA-003: Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (clinicaltrials.gov) - P3 | N=1310 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Aug 2028 ➔ Feb 2030

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

NCI-2018-01054: Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=7 | Terminated | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Apr 2027 ➔ Mar 2026 | Active, not recruiting ➔ Terminated | Trial primary completion date: Apr 2027 ➔ Mar 2026; <75% participation

Biomarker • Trial completion date • Trial primary completion date • Trial termination • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Neuroendocrine Carcinoma • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • PTEN

OMAHA-004: A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) (clinicaltrials.gov) - P3 | N=1314 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Recruiting

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

THE IMPACT OF A GENERIC ALTERNATIVE ON MEDICARE PART D SPENDING FOR ABIRATERONE (SUO 2025) - " Publicly available Medicare Part D data was analyzed from 2013-2023 for all 3 abiraterone formulations available in the United States (Zytiga, Yonsa, and generic abiraterone), extracting number of unique beneficiaries, 30-day fills, and total Medicare Part D spending annually. The introduction of a generic version of abiraterone has led to billions of dollars in Medicare cost savings. Generic abiraterone has largely supplanted its branded counterpart, with 98% of abiraterone prescriptions in 2023 being generic. Generic utilization was associated with dramatic reductions in both total Medicare Part D spending and per-beneficiary cost despite an increase in the number of beneficiaries receiving abiraterone."

Medicare • Reimbursement • US reimbursement • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Prostate Cancer • Solid Tumor

OMAHA-004: A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) (clinicaltrials.gov) - P3 | N=1314 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial primary completion date: Dec 2030 ➔ May 2028

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

Decreasing Dosing Regimens of Abiraterone 500 mg in Men With Prostate Cancer to Find Lowest Recommended Dose. (clinicaltrials.gov) - P1 | N=50 | Terminated | Sponsor: University of Chicago | Trial completion date: Nov 2025 ➔ Nov 2024 | Active, not recruiting ➔ Terminated | Trial primary completion date: Jul 2025 ➔ Nov 2024; Closed by PI due to not meeting primary endpoint

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

OMAHA1: Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (clinicaltrials.gov) - P3 | N=1310 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Active, not recruiting ➔ Recruiting

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

OMAHA-004: A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) (clinicaltrials.gov) - P3 | N=1500 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

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

OMAHA1: Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) (clinicaltrials.gov) - P3 | N=1200 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

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

Risk Stratified De-escalated Hormone Therapy With Radiation Therapy for the Treatment Prostate Cancer (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: Mayo Clinic | N=57 ➔ 110

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

A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces (clinicaltrials.gov) - P=N/A | N=2313 | Completed | Sponsor: Pfizer | N=1000 ➔ 2313

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

A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P=N/A | N=2731 | Completed | Sponsor: Pfizer | Trial completion date: Oct 2024 ➔ Feb 2025 | Trial primary completion date: Oct 2024 ➔ Feb 2025

Real-world evidence • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (clinicaltrials.gov) - P=N/A | N=3017 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

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

NCI-2018-01054: Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=7 | Active, not recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Apr 2025 ➔ Apr 2027 | Trial primary completion date: Apr 2025 ➔ Apr 2027

Biomarker • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Neuroendocrine Tumor • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • PTEN

REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial (clinicaltrials.gov) - P3 | N=72 | Recruiting | Sponsor: Emory University | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • 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

A Study to Learn About the Study Medicines Called Enzalutamide and Abiraterone in People With Metastatic Castration-resistant Prostate Cancer (clinicaltrials.gov) - P=N/A | N=2733 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed

Real-world evidence • Trial completion • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC) (clinicaltrials.gov) - P=N/A | N=2903 | Active, not recruiting | Sponsor: Pfizer | Completed ➔ Active, not recruiting | N=1800 ➔ 2903 | Trial completion date: Feb 2024 ➔ Jan 2025 | Trial primary completion date: Feb 2024 ➔ Jan 2025

Enrollment change • Enrollment closed • Metastases • Trial completion date • Trial primary completion date • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces (clinicaltrials.gov) - P=N/A | N=1000 | Completed | Sponsor: Pfizer | Active, not recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Apr 2024 | Trial primary completion date: Oct 2024 ➔ Apr 2024

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

Study of Relugolix in Men with Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Sumitomo Pharma Switzerland GmbH | Active, not recruiting ➔ Completed | N=72 ➔ 48 | Trial completion date: May 2025 ➔ May 2024 | Trial primary completion date: May 2025 ➔ May 2024

Combination therapy • Enrollment change • Metastases • Trial completion • Trial completion date • Trial primary completion date • Castration-Resistant Prostate Cancer • Castration-Sensitive Prostate Cancer • Genito-urinary Cancer • Neutropenia • Oncology • Prostate Cancer • Solid Tumor