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PT217 is currently under investigation in the phase 1/2 SKYBRIDGE trial in patients with neuroendocrine cancers.

"That pan-tumor approval and this patient case really highlight that in prostate cancer, we should be checking HER2 by immunohistochemistry," says Maneesh R. Jain, MD.

Data showed that all patients achieved a PSA decline of at least 50%.

“The combination of pembrolizumab and chemotherapy presents a promising new treatment approach for these challenging-to-treat, rare cancers and could be a major breakthrough for patient care,” says Arnold I. Chin, MD, PhD.

"Most of the published data about HIFU tended to be with relatively short-term follow-up," says Ralph J. Miller Jr, MD.

The phase 2 CELLVX-230 trial is exploring the potential of FK-PC101 to delay or prevent prostate cancer recurrence following prostatectomy.

Data from the CAPItello-281 trial also showed a trend toward an improvement in overall survival.

In the recent news release, Koelis reported that the final patient was enrolled in the VIOLETTE study in September 2024.

The sNDA is supported by data from the pivotal phase 3 ARANOTE trial.

“Prostate cancer patients with life expectancies of less than 5 or 10 years were being subjected to treatments that can take up to a decade to significantly improve their chances of surviving cancer, despite guidelines recommending against treatment," says Timothy J. Daskivich, MD.

Final completion of the ECLIPSE trial is anticipated for February 2029.

“Our study is distinguished by long follow-up, out to 12 years, looking at a broad spectrum of key complications," says Joseph M. Unger, PhD.

The decision was based on an interim readout from the trial, which showed that ONCT-534 did not lead to any clinically meaningful improvement of disease.

In total, the study plans to enroll 84 adult patients across clinical trial sites in the United States and Australia.

The decision comes after a pre-specified futility analysis determined that it was unlikely that the study would meet its primary end point.

The NDA submission is supported by data from a single-arm, phase 3 trial of leuprolide mesylate administered as 2 injections, 3 months apart.

Patients with higher baseline HEI and E-HEI scores were less likely to experience grade reclassification.

The codes will go into effect on January 1, 2026.

At 5 years, 95.8% of patients in the SBRT arm were free from biochemical or clinical failure compared with 94.6% of patients in the control radiotherapy arm.

The application is supported by data from the pivotal phase 3 ARANOTE trial.

"My hope is that the results of our study improve the uptake of active surveillance, further reducing unnecessary treatments, and this, combined with the improving reflex tests, may change the risk-benefit of PSA screening," says Lisa F. Newcomb, PhD.

“Nivolumab, combined with standard of care trimodality therapy, appears to be promising for the treatment of grade group 5 prostate cancer," says John Michael Bryant, MD.

"The TALAPRO-2 results provide much-needed hope to patients who remain in high unmet need for effective treatment options," said Neeraj Agarwal, MD, FASCO.

"We remain on track for the opening of phase 2 in the next few months. We also expect to see the full phase 1 results presented at a scientific meeting in 2025," says David E. Gauden, DPhil.

The WATER IV PCa will assess Aquablation vs radical prostatectomy in patients with grade group 1 to 3 localized prostate cancer.

Pastuszak discusses the evolving nature of understanding how testosterone therapy post-radiation for prostate cancer may beneficial or harmful to patients, and how to navigate the decision.

Soumyajit Roy, MS, MBBS, explains how findings showing 5-year biochemical recurrence status may predict prostate cancer cure should alter the clinician-patient interaction.

At the 24-month time point, patients who received apalutamide had a 23% reduction in the risk of death compared with patients who initiated enzalutamide.

Findings from RAPTOR suggest 5-year biochemical recurrence may be a good indication of prostate cancer cure status.

Demogeot discusses his team's GETUG 14 findings regarding early administration of ADT plus high-dose radiotherapy for intermediate to high risk prostate cancer.