Assessment of Efficacy and Safety of New Androgen Receptor Inhibitors in Metastatic Castration Resistant Prostate Cancer: A Randomized Controlled Trial
Submission: 02 September 2025 | Acceptance: 29 September 2025 | Publication: 21 October 2025
1Dr. Muhammad Waqas Khan, 2Zamin Abbas, 3Ahmed Haroon, 4Muhammad Arsalan Butt,5Danish Marwat, 6Jahangir Butt
1Assistant Professor in Histopathology, Pathology Department, Pak International Medical College, Peshawar.
2Service Hospital, Lahore
3Mayo Hospital, Lahore
4Azra Naheed Medical College, Lahore
5PIMS, Islamabad
6Sir Gangaram Hospital, Lahore
Abstract
Background:
Metastatic castration-resistant prostate cancer (mCRPC) is an arduous treatment despite improved systemic treatment. New androgen receptor inhibitors (ARIs) are extremely effective in their efficacy, yet their efficacy and safety profiles in the clinic need to be compared.
Aim:
This randomized controlled trial sought to determine if the efficacy and safety of new ARIs is comparable to best available therapy in patients with mCRPC.
Methods:
Confirmed mCRPC patients were randomized to new ARIs or conventional androgen-deprivation therapy. Progression-free survival (PFS), overall survival (OS), prostate-specific antigen (PSA) response, and adverse events related to treatment were the endpoints.
Results:
Patients treated with ARIs had much better PFS and OS than with standard treatment. PSA response rates were better in the patient group receiving ARIs, and the concerns regarding safety were manageable and occurred in the form of fatigue and hypertension only.
Conclusion:
New generation ARIs significantly enhance survival outcome and disease control in men with mCRPC with an acceptable safety profile to include them as a component of standard treatment protocols.
Keywords: Androgen Receptor Inhibitors, Metastatic, Castration Resistant Prostate Cancer, Randomized Controlled Trial.