Prostate Cancer Awareness Month 2025: Advances in Screening and Treatment

Every September, Prostate Cancer Awareness Month calls attention to one of the most common but often overlooked cancers affecting men.

Prostate cancer accounts for a significant portion of new cancer diagnoses worldwide, yet discussions around it are often muted by stigma, embarrassment or lack of awareness. This month provides an important reminder: early detection saves lives.

Prostate Cancer Awareness and Statistics

According to global cancer data, prostate cancer is the second most commonly diagnosed malignancy among men worldwide and ranks as the fifth leading cause of cancer-related death.

In the US, the American Cancer Society projects over 313,000 new cases in 2025, with around 35,000 deaths. It is the most common form of cancer in American men, excluding non-melanoma skin cancer.

In Canada, an estimated 27,900 men were diagnosed with prostate cancer in 2024, representing about one in five of all new cancer cases in men. The Canadian Cancer Society estimates that one in eight men in Canada will be diagnosed with prostate cancer in their lifetime.

Despite these statistics, survival rates are encouraging when prostate cancer is caught early. The five-year survival rate for localized prostate cancer is 97.9%, underscoring the importance of awareness and screening.

Risk Factors for Prostate Cancer

Several factors influence the risk of developing prostate cancer:

• Age: Risk rises significantly after age 50. More than 60% of cases are diagnosed in men over 65.
• Family History: Having a father or brother with prostate cancer doubles a man’s risk. Certain genetic mutations (such as BRCA1/2) also increase risk. Men with Lynch syndrome, also known as hereditary non-polyposis colorectal cancer (HNPCC), which results from inherited gene mutations, also face a higher risk of developing several cancers, including prostate cancer.
• Ethnicity: Black men are about 1.7 times more likely to be diagnosed and 2.1 times more likely to die from prostate cancer compared to white men due to both genetic and socioeconomic factors.
• Lifestyle and Environment: Research suggests obesity, sedentary lifestyles, smoking, chemical exposure (such as arsenic) and diets high in red meat and low in fruits and vegetables may contribute to higher risk.

Awareness of these factors can help men and their families make informed decisions about screening and lifestyle choices.

Screening: Early Detection Saves Lives

There is no universal rule for prostate cancer screening, but tools like the prostate-specific antigen (PSA) test and digital rectal exam (DRE) are effective in detecting cancer at an early stage.

The US Preventive Services Task Force (USPSTF) recommends that men aged 55 to 69 make individual decisions about PSA testing after discussing potential benefits and risks with their doctor.

Men at higher risk, such as Black men or those with a strong family history, are often advised to begin these discussions earlier, around age 40 to 45.

While PSA testing has been debated due to the risk of overdiagnosis, recent studies show that tailored screening strategies can reduce unnecessary treatment while still catching aggressive cancers early.

What’s New in Prostate Cancer Screening and Treatment

Radioligand Therapy Moves Earlier

Novartis’s radioligand therapy Pluvicto (Lu-177–PSMA-617) moved up in the prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) treatment line (pre-taxane) in the US after receiving an FDA label expansion on March 28, 2025, enabling use after one androgen receptor pathway inhibitor (ARPI) in PSMA-positive disease.

This roughly triples the eligible population versus the prior post-taxane label. From a commercial/business perspective, more imaging (PSMA-PET) and manufacturing capacity for Lu-177 will be critical. Also expect payer utilization controls around PSMA expression and prior ARPI exposure.

According to Novartis, Pluvicto remains the only PSMA-targeted therapy backed by Phase III data showing a significant improvement in radiographic progression-free survival (rPFS) and a well-characterized safety and tolerability profile in both pre- and post-taxane settings for patients with ARPI-treated, PSMA-positive mCRPC.

It is also the first and only approved radioligand therapy available for PSMA-positive mCRPC patients before chemotherapy is required.

Novartis is now advancing Pluvicto into earlier disease settings, including metastatic hormone-sensitive prostate cancer and oligometastatic prostate cancer. If approved, this would further expand the addressable market and bring earlier PSMA-PET staging into routine care.

Pfizer’s Talzenna and Xtandi Combo Shows Durable Survival Benefit

In June, the FDA approved updated labeling for Pfizer’s Talzenna (talazoparib) and Xtandi (enzalutamide) combination, adding final overall survival (OS) results to its indication in adults with HRR gene-mutated mCRPC. The approval was supported by results from the Phase III TALAPARO-2 trial, which showed a significant and clinically meaningful improvement in OS in patients with HRR-mutated mCRPC (median OS ~45 vs 31 months for the combination versus Xtandi + placebo, respectively). The agency did not broaden the indication to patients with non-HRR gene-mutated mCRPC.

Imaging Continues to Rewire the Pathway

As radioligand therapies and other PSMA-targeted strategies shift earlier in the treatment paradigm, PSMA-PET imaging is becoming increasingly central to both staging and therapy eligibility. This evolution will likely require payers and health systems to invest in scaling scanner access, ensuring a reliable supply of tracers and standardizing reporting practices. Vendors offering quantitative imaging and longitudinal tracking tools may be particularly well positioned in this landscape.

Smarter, More Selective Screening

Biomarker and MRI-based strategies are increasingly being adopted to reduce unnecessary prostate biopsies while maintaining the ability to detect clinically significant cancers. Recent reviews highlight that reflex tests such as the 4Kscore can reduce biopsy rates by 30 to 50%, without compromising the detection of high-grade disease (≥ Gleason Score 7). This trend is shaping clinical guidelines toward risk-adapted pathways: for example, using PSA testing followed by reflex biomarker assessment and/or MRI prior to targeted biopsy. From a health economics perspective, these strategies promise fewer biopsies, greater diagnostic specificity and reduced downstream over-treatment.

ctDNA for MRD and Treatment Guidance

Emerging clinical data validate the role of circulating tumor DNA (ctDNA) in detecting minimal residual disease (MRD) following local therapy and in monitoring treatment response in advanced prostate cancer. Early ctDNA positivity has been shown to correlate with shorter progression-free survival (PFS) and may help identify patients most likely to benefit from treatment intensification. This body of evidence is laying the groundwork for ctDNA-guided clinical trials and could position ctDNA as a candidate for FDA qualification as a drug development endpoint. On the diagnostics side, there is growing demand for analytically validated assays and standardized thresholds to guide treatment decisions.

AI Steps from “Cool” to Clinically Useful

In the pathology domain, AI-driven grading systems for prostatectomy slides are now demonstrating prognostic performance that matches or even exceeds pathologists in predicting metastasis risk. These tools could soon be integrated into digital pathology platforms as risk-stratification companions, quality-control aids and potentially as CDx-adjacent analytics for clinical trial enrichment.

AI is also making headway in treatment selection. In 2025, researchers reported an AI biomarker capable of predicting which patients with high-risk, non-metastatic prostate cancer would benefit from Johnson & Johnson’s Zytiga (abiraterone).

How You Can Support Prostate Cancer Awareness

• Wear Blue: The official color for prostate cancer awareness.
• Share Knowledge: Post facts and resources on social media to reach a wider audience.
• Support Advocacy and Research: Organizations like Prostate Cancer Foundation (US) and Prostate Cancer Canada fund vital research and patient support.
• Encourage Check-ups: Remind the men in your life to have regular health exams and talk to their doctors about screening.

Breaking the Silence Around Men’s Health

Cultural stigma and discomfort often prevent men from discussing prostate health, even with close family or healthcare providers. This silence can be deadly. Prostate Cancer Awareness Month 2025 aims to normalize these conversations and encourage men to take charge of their health. Family members, especially partners and adult children, play a critical role in prompting men to seek medical advice and screenings.