Prostate Cancer

“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.

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.

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.

“So, this study is really getting at that question, could radiation target the lesions that we see on PET, and could we delay hormone therapy for men?” says Bridget Koontz, MD.

Oliver Sartor, MD, discusses how a 70-year-old man with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) represents a typical candidate for PSMA-targeted imaging and potential radioligand therapy, considering factors such as disease progression, previous treatments, and overall health status in tailoring management strategies.

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.

The panelist discusses how the ARANOTE trial demonstrated significant benefits of adding darolutamide to androgen deprivation therapy for patients with metastatic hormone-sensitive prostate cancer, showing improvements in radiographic progression-free survival and other key outcomes.

Fred Saad, CQ, MD, FRCS, FCAHS, discusses how darolutamide offers potential advantages over other androgen receptor–targeted therapies for metastatic prostate cancer, including its unique molecular structure, favorable safety profile, and efficacy in specific clinical scenarios.

“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 need to close that gap, and just as a general rule, screen our prostate cancer patients more closely for depression, especially those with androgen deprivation therapy,” says Mihir S. Shah, MD.

"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.

“We noticed that if you were White and had prostate cancer and received androgen deprivation therapy, you were more likely to be diagnosed with depression compared to your Black counterparts,” says Mihir S. Shah, MD.

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

The panelist discusses how patient characteristics, disease factors, and individual health status guide the decision to include or avoid chemotherapy in combination treatments for metastatic prostate cancer, weighing potential benefits against risks and quality of life considerations.

Fred Saad, CQ, MD, FRCS, FCAHS, discusses how the inclusion of chemotherapy, particularly docetaxel, in combination therapies for metastatic prostate cancer alters the adverse event profile, noting that while the ARASENS trial found adverse effects to be largely consistent with previous docetaxel studies, they consider whether this aligns with observations in clinical practice.

"When we looked at the same phenotypic data, but focusing on each immunochemistry protein markers, we had 10 patients with AR negative tumor with clearly worse prognosis, and synaptophysin-positive and chromogranin A-positive patients also had a worse prognosis," says Cedric Pobel, MD.

"At the University of Michigan, we've actually started to offer prostate MRI without contrast for patients on active surveillance, which has been a really exciting change," says Benjamin Pockros, MD, MBA.