Prostate Cancer

The Mona Lisa 2.0 platform has been previously approved in the US, Australia, and Singapore.

The PDUFA target action date has been set for August 29, 2025.

Following an initial dose of VIR-5500 of 120 µg/kg or higher, all patients achieved a PSA reduction.

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

Catch up on all the notable drug and device approvals in urology over the past year.

As the year comes to a close, we revisit some of this year’s top content on prostate cancer.

The alert was issued to clarify that the devices should not be used for suction and irrigation.

“Our findings highlight the coordinated interplay between GCN2 and p53 regulation during nutrient stress and provide insight into how they could be targeted in developing new therapeutic strategies for [prostate cancer]," write the authors.

Pluvicto was approved by Health Canada in August 2022.

From baseline to 1 year, the Ki-67 index decreased in the dietary intervention cohort by 15% and increased in the control cohort by 24%.

"We found that with a 5-year Kaplan-Meier survival analysis that patients with varicocele had worse outcomes than patients without varicocele," says Muhammed A. Moukhtar Hammad, MBBCh.

“If approved, this approach has the potential to transform the treatment paradigm in prostate cancer, offering patients with localized disease an effective treatment option that may reduce the risk of disease recurrence," says Glen Gejerman, MD, MBA.

Specifically, 90% of patients in the HIFU arm vs 86% of patients in the radical prostatectomy arm were free from subsequent definitive treatment at 30 months.

The clearance is supported by data from the PRESERVE trial, which evaluated the safety and effectiveness of the NanoKnife System in patients with intermediate-risk prostate cancer.

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.

"I think that as patients go through this, it's a reminder that it's very scary," says MIchael Jenson, PA-C.

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

"Honestly, there really isn't another measure of sexual quality of life for females that addresses the specific concerns of the female partners of patients with prostate cancer," says Stacy Loeb, MD, MSc, PhD (hon).

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

"I think that now we have good data that patient-reported outcomes have to be considered in these patient populations," says Andrew C. Peterson, MD, MPH.

"Every practice is going to be a little bit different on how they would like to approach this," says Michael Jenson, PA-C.

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.

Oliver Sartor, MD, discusses how unmet needs and clinical challenges for PSMA imaging in prostate cancer patients include standardizing interpretation criteria, addressing false negatives in certain tumor phenotypes, improving accessibility and cost-effectiveness, and developing strategies for patients with low PSMA expression or PSMA-negative disease.