June Prostate Cancer Highlights: Top 5 Updates Patients Should Know

CURE is sharing the latest FDA approvals, label expansions, and emerging data on the role of AI in care.

During the month of June, investigators reported on new data that has advanced the prostate cancer treatment landscape. These advancements include new FDA approvals, label expansions, and addressing the growing utility of artificial intelligence (AI).

Moreover, the month of June also brought insights in the form of investigators breaking down how specific therapeutic options in the treatment landscape work for patients, as Dr. Alicia Morgans addressed complications with androgen deprivation therapy (ADT) and how to successfully manage quality of life during treatment.

As these updates and treatment breakdowns continue to provide insights for patients, be sure to read on for more information on these updates below.

FDA Updates Treatment Label for HRR+ Metastatic Prostate Cancer

In June 19, Talzenna (talazoparib) plus Xtandi (enzalutamide) received a label update from the FDA for men with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer; however, this update will not expand to include non-HRR gene mutations. This decision was supported by data from the phase 3 TALAPRO-2 trial.

The TALAPRO-2 trial showed that treatment with the investigative treatment had a statistically significant and clinically meaningful improvement in overall survival. Specifically, at a median follow-up of 44.2 months, the median overall survival was 45.1 months for those receiving the combination versus 31.1 months for those receiving a placebo. Importantly, this translates to a 14-month improvement and a 38% reduction in the risk of death.

“Men with metastatic castration-resistant prostate cancer are often faced with a poor prognosis and limited treatment options, and Talzenna in combination with Xtandi has redefined the standard-of-care for patients living with HRR gene-mutated metastatic castration-resistant prostate cancer,” Dr. Johanna Bendell, oncology chief development officer, Pfizer, said of the label expansion. “We are pleased that the statistically significant final overall survival data reaffirming the current indication has been added to the label, based on the strong results from TALAPRO-2.”

FDA Approves Nubeqa in Some With Prostate Cancer

Earlier this month on June 3rd, the regulatory agency also approved Nubeqa (darolutamide) treatment for patients with metastatic castration-sensitive prostate cancer. This approval was supported by data from the randomized phase 3 ARANOTE trial which investigated the efficacy and safety of Nubeqa versus placebo in 669 patients with this disease.

Treatment with Nubeqa versus placebo significantly improved radiographic progression-free survival, and though the median radiographic progression-free survival was not reached with Nubeqa, it was 25 months with the placebo. Notably, there was no statistically significant difference in overall survival at the time of the final analysis.

Side effects observed in the Nubeqa patient group aligned with those previously reported for the drug when used alone. The prescribing information includes warnings for ischemic heart disease, seizures and embryo-fetal toxicity.

Addressing Complications from ADT Therapy to Treat Prostate Cancer

At a recent CURE Educated Patient® Prostate Cancer Summit, Dr. Alicia Morgans, genitourinary medical oncologist and director of the Survivorship Program at Dana-Farber Cancer Institute, provided updates on managing quality of life during ADT. While ADT remains a cornerstone of prostate cancer treatment due to its ability to suppress testosterone — a key hormone that fuels prostate cancer growth — Morgans emphasized the importance of addressing its physical and emotional side effects.

She noted that reducing testosterone levels can significantly impact patients’ well-being, potentially leading to fatigue, cognitive changes and metabolic complications. During the event, Morgans highlighted emerging strategies and supportive care approaches aimed at helping patients navigate these challenges while preserving their quality of life throughout and beyond the course of treatment.

“Patients with prostate cancer who are living with or after hormonal treatment are at risk for multiple challenges, multiple complications, including things that affect heart, bones, muscles, blood sugar, mood and other systems. But there are ways that we can identify these challenges and prevent or reverse the effects,” Morgans stated in an interview with CURE after the event. “Through exercise, healthy diet, working with primary care, making the diagnosis is the first step, and talking with loved ones about what you need and what they need can be critical, and again, making life better during or after ADT.”

Utilizing AI in Prostate Cancer Care and Management

AI is rapidly emerging as an integral tool in the prostate cancer care continuum, according to experts who shared updates with CURE.

Recent findings presented at the American Urological Association’s annual meeting in April underscored AI’s growing role. A UCLA-led study revealed that AI-generated cancer mapping accurately predicted seminal vesicle invasion (SVI) — the spread of cancer to the seminal vesicles — even though the model had not been specifically trained to identify this feature. Researchers reported that AI outperformed MRI in predicting SVI, offering implications for earlier detection. The study results were published in the Journal of Urology.

The role of AI in prostate cancer management is rapidly evolving, with ongoing advancements poised to refine diagnosis, treatment planning, and patient outcomes, investigators emphasized.

FDA Approves Illuccix to Guide Radioligand Use in Prostate Cancer

On June 23, the FDA approved an expanded indication for Illuccix, a kit used to prepare gallium Ga-68 gozetotide for injection. Illuccix, following the approval, may now be used to identify patients with metastatic castration-resistant prostate cancer who may be eligible for radioligand therapy (RLT) prior to receiving taxane-based chemotherapy.

This means that Illuccix (a radioactive imaging agent) can be utilized in scans to help locate prostate cancer cells in the body which express PSMA (prostate-specific membrane antigen). An expanded indication means that the FDA has expanded the initial approval of Illuccix. This label change follows the FDA’s expanded approval of Pluvicto (lutetium Lu177 vipivotide tetraxetan) for men with metastatic castration-resistant prostate cancer who have received androgen receptor pathway inhibitor therapy but not yet chemotherapy.

“It is pleasing to see the ability to use gallium-68 PSMA-PET for patient selection expanded,” Dr. Scott T. Tagawa, genitourinary oncologist at New York-Presbyterian, Weill Cornell Medical Center, said of the approval. “This empowers clinicians to make more informed, personalized decisions earlier in the disease course and access life-prolonging targeted radionuclide therapy for more patients with prostate cancer.”

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