2015-2025: The Evolution of Prostate Cancer Diagnosis and Treatment Guidelines and Upgrades in Clinical Practice

Prostate cancer is one of the most common malignant tumors in men, with its incidence rising globally, particularly in the context of an increasingly aging population, leading to a growing disease burden. From 2015 to 2025, over this decade, with the rapid development of medical technology, the popularization of precision medicine concepts, and breakthroughs in multi-center clinical studies, the diagnostic and treatment model for prostate cancer has undergone fundamental changes, shifting from traditional "one-size-fits-all" treatments to individualized, precise, and multidisciplinary collaborative comprehensive therapies. As global leaders in prostate cancer diagnosis and treatment, China and the United States exhibit common patterns in the evolution of standard therapies, but also unique paths due to differences in population characteristics, medical resources, and other factors. DengyueMed systematically reviews the development trajectory of prostate cancer diagnosis and treatment over this decade, compares the differences in diagnosis and treatment between China and the US, and looks ahead to future trends.

Development and Changes in Prostate Cancer Diagnosis from 2015 to 2025

Diagnosis is the prerequisite for treatment. Over the decade, the field of prostate cancer diagnosis has achieved a leap from "coarse screening and vague staging" to "precise screening and refined staging." The core breakthroughs are concentrated in four areas: optimization of screening methods, innovation in imaging technology, upgrades in pathological diagnosis, and the popularization of molecular testing, which have completely changed the early detection rate and accuracy of disease assessment for prostate cancer.

In 2015, prostate cancer screening still primarily relied on single prostate-specific antigen (PSA) testing, with a normal reference value of 0-4 ng/ml. Elevated PSA levels indicated the need for further examination, but this method had limited sensitivity and specificity, resulting in a large number of false positives and false negatives—some patients with benign prostatic hyperplasia or prostatitis experienced false PSA elevations, while some with occult prostate cancer might show normal PSA levels, leading to frequent over-biopsies or missed diagnoses. At that time, imaging examinations mainly included transrectal ultrasound and routine CT and bone scans. Transrectal ultrasound was used to guide prostate biopsies, but its ability to identify small lesions was insufficient; routine CT and bone scans could only detect larger metastatic lesions, with low sensitivity for early metastases. In terms of pathological diagnosis, it mainly depended on morphological analysis of small prostate biopsy specimens, using the Gleason scoring system for grading, but the traditional small-section sampling method had limitations, often missing small lesions or misjudging surgical margins due to "piecemeal" sampling, affecting the accuracy of disease assessment. Molecular testing was only used for a minority of high-risk individuals with clear family histories and had not yet entered routine clinical diagnostic processes.

By 2025, prostate cancer diagnosis has formed a "multi-dimensional, three-dimensional, and precise" system. In screening, single PSA testing has gradually been replaced by "PSA combined with Prostate Health Index (PHI)" stratified screening, incorporating risk prediction models based on patient age, family history, lifestyle habits, and other risk factors, which can effectively reduce false positive rates and minimize unnecessary biopsies. Studies on Chinese populations show that after adjusting PHI-specific thresholds for China, the false positive rate decreased by 23%, significantly improving screening efficiency for high-risk groups. The innovation in imaging technology has become the core highlight of the diagnostic field, with multiparametric magnetic resonance imaging (mpMRI) becoming the "gold standard" for prostate cancer screening and biopsy guidance. Its PIRADS grading system can precisely assess the risk of suspected lesions, with PIRADS ≥ 3 requiring targeted and systematic biopsies, greatly improving the detection rate of small lesions; the popularization of new nuclear imaging technologies such as PSMA-PET/CT has further enhanced the sensitivity for detecting metastatic lesions, especially for lymph node and distant metastases in high-risk and metastatic prostate cancer, significantly superior to traditional CT and bone scans. Domestically produced dual-tracer PSMA PET/CT has increased the detection rate of oligometastatic lesions by 73%, changing treatment plans for 51% of patients.

In pathological diagnosis, the whole-mount sectioning technique for radical prostatectomy specimens has been widely promoted. This technique involves layered sampling of prostate specimens to create panoramic whole-mount sections, which can fully display the entire prostate tissue, precisely locate the position, size, and extent of cancer foci, clarify key indicators such as nerve invasion and vascular tumor emboli, providing reliable basis for clinical staging, while reducing the number of sampled blocks from 40-80 to 6-8, greatly improving diagnostic efficiency. Molecular testing has become a routine diagnostic tool, expanding from single BRCA gene detection to ATM, PALB2, and other DNA damage repair (DDR) pathway-related genes, as well as FOXA1, SPOP, and other genes specifically related to prostate cancer progression. Research has found that the FOXA1 mutation rate in Chinese prostate cancer patients is as high as 41% (less than 15% in Western populations), and the ERG gene fusion rate is less than one-third of that in Western patients. This population-specific mutation profile provides important basis for individualized treatment. Currently, 11.8% of metastatic Chinese patients have germline DDR gene mutations, and these patients are sensitive to PARP inhibitor therapy, but as of 2025, clinical testing coverage remains below 20%, becoming a key direction for future diagnostic optimization.

Over the decade, the core change in prostate cancer diagnosis has been the shift from "detecting tumors" to "precisely assessing tumors." The early detection rate of prostate cancer has significantly increased, with the early detection rate among Chinese men over 50 rising from less than 5% in 2015 to over 25% in 2025, although still lagging behind the US's 46.3%, the gap has notably narrowed; at the same time, precise staging and molecular subtyping provide a solid foundation for subsequent individualized treatment plans, avoiding "blind treatment" and "overtreatment."

Milestone Events in Standard Therapies for Prostate Cancer in China and the US Over the Past Decade

From 2015 to 2025, both China and the US have achieved a series of breakthrough progresses in the exploration of standard therapies for prostate cancer. Numerous milestone events have driven innovations in treatment concepts and iterations of standard therapies, expanding from traditional surgery, radiotherapy, and endocrine therapy to diversified treatment methods such as targeted therapy, immunotherapy, and radionuclide therapy, forming a treatment system covering the entire disease course of "localized, locally advanced, and metastatic" stages. Due to differences in population characteristics (high proportion of advanced-stage diagnoses in Chinese prostate cancer patients, high early detection rates in the US), medical resource distribution, and clinical research focuses, the emphases of milestone events also differ, but overall, both are moving toward "precision, individualization, and combination" directions.

Milestone Events in the US Over the Past Decade

In 2015, the US Food and Drug Administration (FDA) approved enzalutamide for first-line treatment of metastatic castration-resistant prostate cancer (mCRPC) patients, breaking the dominance of traditional chemotherapy in mCRPC treatment and marking the entry of prostate cancer targeted endocrine therapy into a new era. Enzalutamide, as a new-generation androgen receptor antagonist, can effectively block the androgen receptor signaling pathway, delay tumor progression, significantly extend patient survival, and has better tolerability than chemotherapy.

In 2017, the FDA approved abiraterone combined with prednisone for the treatment of metastatic high-risk castration-sensitive prostate cancer (mHSPC), advancing the application of targeted endocrine therapy from the castration-resistant stage to the castration-sensitive stage, changing the standard treatment model for mHSPC—previously, mHSPC treatment mainly consisted of androgen deprivation therapy (ADT) alone, and combining abiraterone significantly extended median survival, opening the prelude to "combination therapy" for mHSPC. In the same year, active surveillance was formally included in the standard treatment plan for low-risk localized prostate cancer, based on results from clinical trials such as SPCG-4 and PIVOT, confirming that for low-risk patients, active surveillance (relying on dynamic PSA monitoring, regular mpMRI follow-up, and biopsies as needed) can avoid overtreatment, preserve patient quality of life, and 10-year follow-up shows its safety comparable to active treatment.

In 2020, the FDA approved PSMA-targeted radionuclide therapy (177Lu-PSMA-617) for mCRPC patients who have failed multiple lines of treatment, representing a major breakthrough in precise targeted therapy for prostate cancer. This therapy can specifically bind to the PSMA antigen on the surface of prostate cancer cells, achieving "precise killing" of tumor cells while reducing damage to normal tissues, significantly improving survival quality and survival time for advanced patients.

In 2022, the FDA approved the PARP inhibitor olaparib for first-line treatment of mCRPC patients with BRCA1/2 gene mutations, marking the entry of prostate cancer into the era of "precision targeted therapy guided by molecular subtyping," achieving precise matching of "gene mutation-targeted drug," providing new treatment options for advanced patients with specific gene mutations. In the same year, multiple clinical studies confirmed that stereotactic body radiotherapy (SBRT) for localized prostate cancer is non-inferior in efficacy to traditional radical surgery, with less trauma and fewer complications, becoming an important treatment choice for low-risk and intermediate-risk localized prostate cancer.

In 2024, the US National Comprehensive Cancer Network (NCCN) guidelines recommended "ADT combined with novel anti-androgen drugs + chemotherapy" triple therapy as the preferred treatment plan for high-risk mHSPC patients. Based on multi-center clinical trial results, this regimen can further extend progression-free survival and overall survival, becoming a new benchmark for combination therapy in advanced prostate cancer.

Milestone Events in China Over the Past Decade

In 2016, the Chinese Urological Surgery Guidelines first included laparoscopic and robotic-assisted laparoscopic radical prostatectomy in the standard treatment plan for localized prostate cancer, gradually replacing traditional open surgery. These minimally invasive surgeries have advantages such as small trauma, less bleeding, and fast postoperative recovery, allowing precise preservation of neurovascular bundles and reducing complications like postoperative urinary incontinence and erectile dysfunction, promoting the minimally invasive development of prostate cancer surgical treatment in China.

In 2018, new-generation anti-androgen drugs such as enzalutamide and abiraterone were formally included in China's medical insurance catalog, significantly reducing the treatment burden for patients, making these targeted drugs from "inaccessible" to "accessible," propelling China's metastatic prostate cancer treatment into the "targeted era," changing the previous dilemma where advanced patients could only rely on chemotherapy and traditional endocrine therapy. In the same year, the whole-mount sectioning technique for radical prostatectomy specimens promoted by the team at Fudan University Affiliated Cancer Hospital was included in China's pathological diagnosis standards after multi-center clinical validation, significantly improving the precision of domestic prostate cancer pathological diagnosis.

In 2021, the Phase III clinical trial (CHART study) of the domestically produced novel anti-androgen drug Rezvilutamide achieved milestone results. The study enrolled 654 patients with high tumor burden metastases, confirming that Rezvilutamide combined with traditional endocrine therapy could reduce the risk of death by 42%, with efficacy non-inferior to imported drugs and superior safety. Subsequently, Rezvilutamide was approved for the treatment of mHSPC patients, marking China's entry into the "domestic substitution" era for prostate cancer targeted therapy.

In 2023, the Chinese Society of Clinical Oncology (CSCO) Prostate Cancer Guidelines first included PSMA-PET/CT in routine staging examinations for high-risk prostate cancer, and incorporated PARP inhibitors olaparib and rucaparib into treatment recommendations for mCRPC patients with DDR gene mutations, promoting the alignment of China's prostate cancer diagnosis and treatment with international standards. In the same year, for locally advanced prostate cancer, the radical surgery combined with neoadjuvant chemotherapy regimen was included in guideline recommendations, reducing positive margin rates by 39% and increasing three-year progression-free survival to 82%, significantly improving prognosis for locally advanced patients.

In 2024, multi-center clinical studies in China confirmed that stereotactic radiotherapy combined with systemic therapy for prostate cancer patients with oligometastases could increase local control rates by 78%, with grade 3 or higher toxicities controlled within 4%. This regimen was included in the guidelines, filling the gap in standardized treatment for oligometastatic prostate cancer in China.

Comparison of Current Optimal Treatments in China-US Guidelines

As of 2025, both the US NCCN Prostate Cancer Guidelines and China's CSCO Prostate Cancer Guidelines have formed optimal treatment recommendations covering the entire disease course of "localized, locally advanced, and metastatic" stages. They maintain consistency in core treatment principles, both emphasizing "individualized treatment and multidisciplinary collaboration (MDT)," but due to differences in clinical characteristics of prostate cancer patients, medical resource distribution, and drug accessibility between China and the US, there are notable differences in specific treatment plan selections and recommendation priorities, mainly in the three stages of localized, locally advanced, and metastatic prostate cancer.

Localized Prostate Cancer (Clinical Stages T1-T2)

The optimal treatment recommendations in the US NCCN Guidelines exhibit "diversified and minimally invasive" characteristics, formulating personalized plans based on patient age, physical condition, and tumor risk stratification (low, intermediate, high): For low-risk patients (PSA <10 ng/ml, Gleason score ≤6, clinical stage T1c-T2a), active surveillance is preferred to avoid overtreatment, with stereotactic body radiotherapy (SBRT) or minimally invasive radical prostatectomy recommended only for patients who desire treatment; for intermediate-risk patients (PSA 10-20 ng/ml, Gleason score 7, clinical stage T2b-T2c), minimally invasive radical prostatectomy (mainly robotic-assisted) or radiotherapy combined with short-term endocrine therapy (4-6 months) is recommended; for high-risk patients (PSA >20 ng/ml, Gleason score 8-10, clinical stage T3-T4), radical prostatectomy combined with adjuvant radiotherapy/endocrine therapy, or radical radiotherapy combined with long-term endocrine therapy (2-3 years) is recommended. The US's advantages lie in the high普及 of minimally invasive techniques and radiotherapy, with a well-established active surveillance follow-up system, effectively balancing treatment efficacy and patient quality of life.

The optimal treatment recommendations in China's CSCO Guidelines focus on "radical treatment, with gradual promotion of active surveillance." The core reasons are that the proportion of low-risk prostate cancer patients in China is lower than in the US, public acceptance of active surveillance is low, and grassroots medical follow-up systems are imperfect. Specific recommendations: Low-risk patients may choose active surveillance (limited to those with good follow-up conditions) or minimally invasive radical prostatectomy, radiotherapy; intermediate-risk patients prefer minimally invasive radical prostatectomy, or radiotherapy combined with short-term endocrine therapy; high-risk patients recommend radical prostatectomy combined with adjuvant radiotherapy/endocrine therapy, or radical radiotherapy combined with long-term endocrine therapy. Compared to the US, the universal of robotic-assisted laparoscopic surgery in China still has gaps, with some grassroots hospitals still mainly using laparoscopic or open surgery; stereotactic body radiotherapy (SBRT) is mainly concentrated in large tertiary hospitals and has not yet been popularized at the grassroots level; the promotion of active surveillance still faces issues such as insufficient patient awareness and irregular follow-up.

Locally Advanced Prostate Cancer (Clinical Stages T3-T4)

Both China and US guidelines adopt "comprehensive treatment" as the core principle, emphasizing "surgery/radiotherapy combined with endocrine therapy," but there are differences in treatment plan priorities and details. The US NCCN Guidelines recommend: For patients in good physical condition without surgical contraindications, radical prostatectomy combined with adjuvant endocrine therapy +/- radiotherapy is preferred, which can effectively remove the primary tumor and reduce local recurrence risk; for patients unable to tolerate surgery, radical radiotherapy combined with long-term endocrine therapy (2-3 years) is recommended, and can be combined with novel anti-androgen drugs to enhance efficacy. Additionally, the US guidelines recommend neoadjuvant therapy (endocrine therapy +/- chemotherapy) for some locally advanced patients to shrink tumor volume before radical surgery, further improving surgical cure rates.

China's CSCO Guidelines recommend: Radical radiotherapy combined with long-term endocrine therapy, or radical prostatectomy combined with adjuvant endocrine therapy +/- radiotherapy; for patients with higher tumor burden, neoadjuvant endocrine therapy + radical surgery/radiotherapy is recommended. Compared to the US, the application rate of neoadjuvant therapy in locally advanced patients in China is lower, mainly due to insufficient awareness of neoadjuvant therapy in some grassroots hospitals and differences in drug accessibility; additionally, the technical level of radical radiotherapy varies, with radiotherapy precision at grassroots hospitals needing improvement, affecting treatment efficacy. Furthermore, China's guidelines emphasize the use of domestically produced novel anti-androgen drugs for locally advanced patients, balancing efficacy and economy.

Metastatic Prostate Cancer (Clinical Stage M1)

Metastatic prostate cancer is divided into metastatic castration-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (mCRPC). The differences in treatment recommendations between China and US guidelines mainly focus on drug selection and priorities of combination therapy regimens, with core reasons being differences in drug accessibility and patient population characteristics.

For mHSPC: The US NCCN Guidelines recommend, for low tumor burden patients, ADT combined with novel anti-androgen drugs (enzalutamide, abiraterone, etc.); for high tumor burden patients, ADT combined with novel anti-androgen drugs + chemotherapy (docetaxel) triple therapy, which can significantly extend patient survival. Additionally, the US guidelines recommend early use of PARP inhibitors for mHSPC patients with DDR gene mutations to enhance efficacy. China's CSCO Guidelines recommend, for low tumor burden patients, ADT combined with novel anti-androgen drugs (imported drugs or domestic Rezvilutamide); for high tumor burden patients, ADT combined with novel anti-androgen drugs, or ADT combined with chemotherapy, with triple therapy only recommended for patients in good physical condition with extremely high tumor burden. The differences are due to the fact that high tumor burden mHSPC patients in China are often elderly with poorer physical conditions, lower tolerance to chemotherapy, and higher treatment costs for triple therapy with limited medical insurance coverage; at the same time, domestic Rezvilutamide has become a key recommended drug in China's guidelines due to its confirmed efficacy and affordable price.

For mCRPC: The US NCCN Guidelines recommend prioritizing plans based on molecular testing results—for those with DDR gene mutations, PARP inhibitors (olaparib, rucaparib, etc.) are preferred; for PSMA-positive patients, PSMA-targeted radionuclide therapy (177Lu-PSMA-617) is recommended; for those without clear gene mutations, novel anti-androgen drugs (enzalutamide, abiraterone, etc.) combined with chemotherapy, or immunotherapy combined with targeted therapy. The US's advantages lie in the high universal of PSMA-targeted radionuclide therapy and novel PARP inhibitors, with molecular testing coverage nearing 100%, enabling "precise matching" treatment plans. China's CSCO Guidelines recommend, novel anti-androgen drugs (imported drugs or domestic Rezvilutamide) combined with chemotherapy as first-line; PARP inhibitors for those with DDR gene mutations; PSMA-targeted radionuclide therapy only for patients who have failed multiple lines of treatment and are PSMA-positive. The differences are due to the lower universal of equipment and drugs for PSMA-targeted radionuclide therapy in China, available only in a few large tertiary hospitals; molecular testing coverage below 20%, leaving many patients with gene mutations unable to receive precise targeted therapy; at the same time, the application of immunotherapy in prostate cancer is still in the exploratory stage and has not become a routine recommendation.

Additionally, there are differences in supportive care between China and US guidelines: The US NCCN Guidelines pay more attention to maintaining patient quality of life, recommending routine pain management, nutritional support, psychological interventions, and other supportive treatments; China's CSCO Guidelines also emphasize supportive treatment, but supportive care systems in grassroots hospitals are imperfect, with lower clinical application rates.

Future Trend Predictions

Combining the development trajectory of prostate cancer diagnosis and treatment over the past decade, as well as the current innovative directions in medical technology, in the next 5-10 years, standard therapies for prostate cancer will develop toward "more precise, more minimally invasive, more individualized, and more inclusive" directions, while the diagnosis and treatment gap between China and the US will gradually narrow. The core trends are concentrated in the following five areas.

· Comprehensive popularization of molecular testing, achieving "individualized treatment guided by precise subtyping."

· Iterative upgrades in targeted therapy and immunotherapy, becoming core treatment methods for advanced prostate cancer.

· Further popularization of minimally invasive treatments and precise radiotherapy techniques, balancing efficacy and quality of life.

· Comprehensive promotion of multidisciplinary collaborative (MDT) diagnostic and treatment models, becoming routine diagnostic processes.

· Continuous improvement of prevention and screening systems, promoting "early detection, early diagnosis, early treatment" for prostate cancer.

· Gradual narrowing of the diagnosis and treatment gap between China and the US, forming a "localization combined with internationalization" diagnostic and treatment system.

In the future, China and the US will conduct more collaborations in prostate cancer clinical research, jointly promoting the elevation of global prostate cancer diagnosis and treatment levels.

Summary and Outlook

The decade from 2015 to 2025 has been a period of rapid development in the field of prostate cancer diagnosis and treatment. In diagnosis, it has achieved a leap from "coarse" to "precise," and in treatment, from "single therapy" to "comprehensive therapy." As global leaders in prostate cancer diagnosis and treatment, China and the US have significantly improved early detection rates, treatment efficacy, and quality of life for prostate cancer patients through a series of milestone breakthroughs, propelling prostate cancer from a "difficult-to-treat tumor" toward a "preventable, treatable, manageable" chronic disease.

Reviewing this decade, the core transformation in prostate cancer diagnosis and treatment lies in the implementation of "precision medicine" concepts—from risk stratification in screening, to molecular subtyping in diagnosis, to individualized plan formulation in treatment, every breakthrough revolves around "precision." The US, with advanced medical technology, a well-established medical system, and rich clinical research experience, leads in minimally invasive treatment, precise radiotherapy, targeted therapy, and other fields, with its diagnostic guidelines providing important references globally; China, combining its own population characteristics and medical resource status, has made significant progress in domestic drug development, popularization of minimally invasive techniques, upgrades in pathological diagnosis, and other areas, gradually narrowing the gap with international standards, forming diagnostic paths with Chinese characteristics, especially the launch of domestic drugs like Rezvilutamide and the promotion of whole-mount sectioning techniques, allowing more Chinese patients to access high-quality diagnostic and treatment services.

At the same time, we should soberly recognize that current prostate cancer diagnosis and treatment still face many challenges: China's early detection rate for prostate cancer remains lower than in developed countries, with uneven distribution of grassroots medical resources, insufficient molecular testing coverage, and some advanced patients still facing limited treatment options and drug accessibility issues; the US faces dilemmas such as overtreatment and high medical costs; globally, the drug resistance mechanisms in advanced prostate cancer are not fully clear, and the efficacy of immunotherapy still needs further improvement—these are key issues to be addressed in the future.

Looking to the future, with continuous innovations in medical technology, prostate cancer diagnosis and treatment will develop toward more precise, more minimally invasive, more individualized, and more inclusive directions. The comprehensive popularization of molecular testing will allow precision treatment to benefit more patients, iterative upgrades in novel targeted drugs and immunotherapies will bring new hope to advanced patients, the popularization of minimally invasive treatments and precise radiotherapy techniques will further balance efficacy and quality of life, the promotion of multidisciplinary collaborative diagnostic models will optimize diagnostic processes, and the improvement of prevention and screening systems will promote "early detection, early diagnosis, early treatment" for prostate cancer.