Prostate Cancer

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.

“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.

"Patients, in general, have been extremely happy, and the one thing that I think keeps them happy is I'm continually evolving with how I give the information," says Michael Jenson, PA-C.

"The 5-year data from STOMP showed that about a third of men could go 5 years without requiring ADT, which is exciting," says Bridget F. Koontz, MD, FASTRO.

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

Oliver Sartor, MD, discusses how 68gallium PSMA-11 PET is indeed the preferred imaging modality for confirming eligibility for lutetium therapy, but when unavailable, alternative options such as F-18 PSMA PET, conventional bone scintigraphy, or CT/MRI may be considered, albeit with potential limitations in sensitivity and specificity.

Panelists discuss how the increased use of androgen receptor–targeted therapy in clinical practice may impact the effectiveness of PARP inhibitor combinations like talazoparib in the TALAPRO-2 study, while also addressing safety concerns, potential differences in trial populations, and the need for future studies to optimize treatment approaches for various metastatic prostate cancer patient subgroups.

Panelists discuss how the PROfound trial (NCT02987543) demonstrated the efficacy and safety of olaparib monotherapy in metastatic prostate cancer patients with homologous recombination repair gene alterations, highlighting its potential as a targeted treatment option and its impact on the landscape of precision medicine in prostate cancer management.

Michael Jenson, PA-C, gives an overview of the Surgical Impotence Management Strategy program at Minnesota Urology.

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.

The panelist discusses how the limited availability of 68gallium PSMA-11 gozetotide in clinical practice poses challenges and suggests potential strategies to increase accessibility, such as expanding production facilities, improving distribution networks, and exploring alternative radiotracers with longer half-lives.

Panelists discuss how PARP inhibitor monotherapy trials like TALAPRO-1 (talazoparib) and TRITON-3 (rucaparib) have demonstrated efficacy and safety in treating metastatic prostate cancer patients with homologous recombination repair gene alterations, providing important insights into targeted therapy options for this specific patient population.

Panelists discuss how the PEACE III trial findings demonstrate the superiority of combining radium-223 with enzalutamide in treating metastatic castration-resistant prostate cancer, highlighting improved efficacy, the critical importance of bone-protective agents in reducing fracture risk, and the potential for this triplet therapy to become the new standard of care over enzalutamide alone.

Bridget Koontz, MD, highlights the design and enrollment criteria of the ongoing phase 2 NRG-GU011 trial.

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.

The panelist discusses how 68gallium prostate-specific membrane antigen-11 (PSMA-11) gozetotide is most useful in PET-CT imaging for detecting and staging prostate cancer.

Panelists discuss how combining radium-223 with androgen receptor–targeted therapy like enzalutamide addresses historical challenges in treating metastatic castration-resistant prostate cancer, including poor radium-223 uptake, prostate-specific androgen–level control issues, and the need for multimodal treatment approaches.

Fred Saad, CQ, MD, FRCS, FCAHS, discusses how the ARANOTE trial results support using darolutamide plus androgen deprivation therapy in a broad range of patients with metastatic hormone-sensitive prostate cancer, offering flexibility in treatment choices by providing an effective non-chemotherapy option that can be tailored to individual patient needs and preferences.