apalutamide

Materials and This prospective cross-sectional, single-center observational study included 130 patients with metastatic prostate cancer receiving AR-targeted therapies (abiraterone, enzalutamide, or apalutamide/darolutamide). These findings highlight the importance of integrating routine psychosocial assessment and supportive care strategies into clinical practice to optimize patient-centered outcomes. However, given the cross-sectional and exploratory nature of the study, the findings should be interpreted cautiously.

P2, N=34, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Jan 2027 --> May 2026

P3, N=586, Active, not recruiting, NRG Oncology | Recruiting --> Active, not recruiting

P2, N=26, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2026 --> Jul 2026

P2, N=200, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Jun 2026 --> Jun 2028

Direct AR antagonism enhances functional PSMA availability and increases short-term uptake of PSMA-targeted radioligands in AR-positive prostate cancer models. These findings provide mechanistic support for AR-mediated modulation of PSMA-targeted radioligand delivery and warrant further translational investigation.

P2, N=192, Recruiting, Sun Pharmaceutical Industries Limited | Not yet recruiting --> Recruiting | Trial completion date: Jun 2026 --> Dec 2027 | Trial primary completion date: Jun 2025 --> Dec 2027

We retrospectively analyzed 148 patients with mHSPC treated with either ARPI (abiraterone, enzalutamide, or apalutamide) plus androgen deprivation therapy (ADT) (n = 98) or docetaxel plus ADT (n = 50). In this real-world cohort, ARPI-based therapy was associated with an improvement in rPFS compared with docetaxel, while OS outcomes remained comparable. In the absence of direct randomized comparisons, these findings may provide supportive real-world evidence for the clinical relevance of ARPI-based therapy as a first-line treatment option for patients with mHSPC.

P3, N=670, Recruiting, AstraZeneca

P3, N=692, Active, not recruiting, Janssen Pharmaceutica N.V., Belgium | Trial completion date: Aug 2029 --> Sep 2031

P1, N=355, Recruiting, Janssen Research & Development, LLC | N=250 --> 355

This study demonstrated that baseline ctDNA predicts prognosis of Japanese patients with mCSPC receiving apalutamide with ADT and identified potential genetic predictors for treatment-related skin rash. Trial Registration: ClinicalTrials.gov identifier: jRCTs071200040.