Prostate Cancer

The PDUFA target action date is in the fourth quarter of 2026.

Olaparib's indications in the US include use as a single agent for patients with HRR gene-mutated mCRPC and in combination with abiraterone and prednisone for patients with BRCA-mutated mCRPC.

These results provided the basis for the ongoing randomized phase 3 ProstACT Global trial evaluating 177Lu-rosopatamab tetraxetan in mCRPC.

The phase 2 study is assessing whether an adaptive treatment approach can improve responses and enable treatment pauses for select patients.

The pivotal phase 3 Himalayas-1 trial will evaluate rinzimetostat plus darolutamide vs with physician's choice of an ARPI or docetaxel.

According to the authors, the findings lay the groundwork for future work of genomics-guided treatment de-escalation in prostate cancer.

The phase 1 trial is assessing the safety and preliminary antitumor activity of actinium (225Ac) rhPSMA-10.1 injection.

A recent meta-analysis suggests that the Prolaris combined clinical risk score is prognostic across NCCN risk groups in men with localized prostate cancer.

These results are intended to support a premarket approval submission for an expanded indication of the Vanquish device for the management of clinically localized prostate cancer.

Interim results from the phase 2 CONVERGE-01 trial showed encouraging antitumor activity and a manageable safety profile with Ac-225 rosopatamab tetraxetan in mCRPC.

The tentative approval spans tablets in 40-mg, 80-mg, 120-mg, and 160-mg strengths.

The following FAQs highlight key recommendations and practical takeaways from the 2026 AUA/SUO Advanced Prostate Cancer Guideline.

Fred Saad, MD, CQ, FRCS, FCAHS, discusses additional efficacy data from the phase 3 PSMAddition trial, evaluating the addition of 177Lu-PSMA-617 to standard of care ADT plus an ARPI in PMSA+ mHSPC.

Enzalutamide plus talazoparib showed promising clinical activity in high-volume mHSPC, although with a notable toxicity burden.

Preston C. Sprenkle, MD, discusses the unmet needs, emerging solutions, and longer-term vision for MRI in prostate cancer care.

Andrew J. Armstrong, MD, MSc, discusses efficacy results from a phase 2 study evaluating a chemoimmunotherapy regimen for patients with neuroendocrine or aggressive-variant metastatic prostate cancer.

Daniel J. George, MD, discusses the clinical significance of the FDA approval of capivasertib, practical considerations for PTEN testing and toxicity management, and the broader implications of precision medicine for patients with advanced prostate cancer.

Louise Emmett, MD, PhD, MBChB, FRACP, discusses findings from the phase 1 AcTION trial, which evaluated the safety and preliminary activity of 225Ac-PSMA-617 in patients with metastatic castration-resistant prostate cancer.

The approval is supported by data from the phase 3 CAPItello-281 trial.

In this video, Benjamin H. Lowentritt, MD, FACS, discusses findings from the real-world OPTYX study, assessing testosterone suppression and recovery among patients receiving relugolix for advanced prostate cancer.

The approval adds another commercially available source of the PSMA-targeted radiotracer.

The addition of aglatimagene and valacyclovir to radiotherapy with or without ADT significantly improved disease-free survival in patients with intermediate- to high-risk localized prostate cancer.

Clint D. Bahler, MD, reflects on key prostate cancer themes from AUA 2026, including the shift toward more personalized care.

Praful Ravi, MB, BChir, MRCP, discusses results from PSMAtrack, which assessed changes in PSMA-PET during initial systemic therapy for metastatic hormone-sensitive prostate cancer.

Pedro C. Barata, MD, MSc, FACP, discusses preliminary findings from the phase 3 ProstACT Global study evaluating 177Lu-rosopatamab plus standard of care for patients with mCRPC.