Optimize the diagnosis and treatment strategy for mHSPC patients, greatly increase the survival rate of prostate cancer, and implement the healthy China strategy

*Only for medical professionals to read the reference introduction.
Advanced prostate cancer innovative drug "apatamide" is China's first and only new androgen receptor approved for "all types" of metastatic endocrine therapy-sensitive prostate cancer (mHSPC) indications AR inhibitors are also China’s first new type of AR inhibitors approved for high-risk non-metastatic castration-resistant prostate cancer (NM-CRPC) indications.
Through the treatment concept of early active intervention, it will bring to the treatment of prostate cancer.
The survival benefit of comprehensive innovation
.

Apataamide can significantly reduce the risk of death in mHSPC patients by 48%, greatly increase the four-year survival rate by 27% (from 38% to 65%), and it is also the only drug that achieves OS for high-risk NM-CRPC patients for more than 6 years
.

At present, it has been first-line recommended by many authoritative guides at home and abroad for mHSPC and high-risk NM-CRPC
.

Apataamide is the "pillar" of hope among thousands of families, and the patient's expectation for a better life
.

Please support the listing of "apatamide" in the National Medical Insurance Catalog, and contribute to the realization of the 5-year survival rate target for healthy China in 2030! The medical history introduced the patient, a 67-year-old male, who was admitted to the hospital on May 20, 2021 due to "2 days of urinary incontinence"
.

▎Past history: history of hypertension ▎Auxiliary examination: May 6, 2021, ultrasound showed: 1.
Increased prostate volume (5.
3*4*3.
9cm) 2.
Residual urine volume in the bladder is about 662ml
.

▎Admission diagnosis: benign prostatic hyperplasia, acute urinary retention, hypertension
.

▎Admission check: Creatinine was 1065µmol/L at the time of admission.
After 6 days of catheterization treatment, on May 26, 2021, creatinine dropped to 85µmol/L
.

On May 21, 2021, total prostate specific antigen (tPSA) was 11.
36 ng/mL, bound prostate specific antigen (cPSA) was 11.
11 ng/mL, and cPSA/tPSA was 0.
98
.

On May 22, 2021, the prostate MRI results showed that the left peripheral zone of the prostate was occupying space.
Consider prostate cancer, with left seminal vesicle invasion (SVI), involvement of left neurovascular bundles (NVBs), inferior bladder wall invasion, and multiple lymph nodes And bone metastases, the prostate imaging score (PI-RADS) is 5 points, and the clinical magnetic resonance staging is T4N1M1
.

Figure 1.
Prostate MRI results.
On May 28, 2021, the results of whole body bone imaging showed that about the fifth thoracic vertebra and the right pelvis near the pubic bone were active in bone metabolism, and there was suspected dense focus on the right ischia and pubic bone.

.

Figure 2.
Whole body bone imaging examination results.
On May 28, 2021, the pathological results of prostate biopsy showed: 1.
(left bottom inner side) prostate cancer, alveolar type, Gleason score: 4+4=8, ISUP classification: 4 Grade, the tumor burden is about 70%
.

2.
(Bottom left side) Prostate cancer, acinar type, Gleason score: 4+4=8, ISUP grade: grade 4, tumor burden is about 50%
.

3.
(Inside left middle part) Prostate cancer, acinar type, Gleason score: 4+4=8, ISUP grade: grade 4, tumor burden is about 40%
.

4.
(Left middle and outer side) Prostate cancer, acinar type, Gleason score: 4+4=8, ISUP grade: grade 4, tumor burden is about 70%
.

5.
(Inside the left apex) prostate cancer, acinar type, Gleason score: 4+4=8, ISUP grade: grade 4, with high-grade intraepithelial neoplasia of the glands, the tumor is about 70%
.

6.
(Left apex lateral) prostate cancer, alveolar type, Gleason score: 4+4=8, ISUP grade: grade 4, tumor burden is about 40%
.

7.
(Inner right bottom) Prostate cancer, acinar type, Gleason score: 4+4=8, ISUP grade: grade 4, tumor burden is about 30%
.

8.
(Bottom right side) Prostate cancer, acinar type, Gleason score: 3+4=7, ISUP grade: grade 4, tumor burden is about 10%
.

9.
(Inside right middle, outside right middle, inside right apex, outside right apex) Nodular hyperplasia of prostate with chronic inflammation
.

10.
The results of immunohistochemistry showed: CK34 β E12(-), P504S(+), P63(-)
.

▎Clinical diagnosis of low tumor burden, metastatic hormone-sensitive prostate cancer (mHSPC) (T4N1M1), acute renal failure, acute urinary retention, filling urinary incontinence, hypertension ▎ After treatment on June 10, 2021, the patient began to receive apatamide + androgen Deprivation treatment (ADT) treatment
.

On June 23, 2021, the serum PSA was rechecked 10 days after the medication, and it was found that the PSA decreased by 72.
6%
.

On July 11, 2021, the serum PSA was rechecked one month after the medication, and it was found that the PSA decreased by 97%
.

Figure 3.
tPSA, cPSA, cPSA/tPSA test results Figure 4.
Luteinizing hormone, testosterone test results case provide doctor's profile Professor Weng Xiaodong, Doctor of Urology, Wuhan University People’s Hospital, Associate Chief Physician, National Full Public Sponsor University of British Columbia (UBC) ) Visiting scholar, Chinese Medical Doctor Association and Andrologist Youth Committee Member, China Integrated Traditional Chinese and Western Medicine Andrology Youth Committee Member, Wuhan Medical Association Pediatric Surgery Branch Member, European Urology Association (EAU) Member, Hubei Anticancer Association, BioMed Research International, Renal Failure Review The author, the communication editor of the Urology Learning Union, won 1 second prize of Provincial Science and Technology Progress Award, participated in 3 general projects of the National Natural Science Foundation of China, presided over and participated in 5 provincial and ministerial funds, and published 41 SCI papers, of which the first Analysis of 10 cases of SCI papers by one author.
The patient was diagnosed with benign prostatic hyperplasia and acute urinary retention when he was admitted to the hospital.
Based on the higher than normal levels of tPSA and cPSA, the patient was diagnosed with prostate MRI, whole body bone imaging and prostate biopsy.
Low tumor burden mHSPC with multiple bone metastases throughout the body
.

Patients with mHSPC treated with ADT alone progress to metastatic castration-resistant prostate cancer (mCRPC) within one to two years [1], and androgen receptor (AR) inhibitors are important therapeutic drugs for mHSPC
.

At present, in the treatment of prostate cancer in Asian countries, traditional combined androgen blockade (CAB) is still the main treatment for patients with mHSPC stage, but the CAB program based on traditional AR inhibitors has limited benefits [2], currently The latest international guidelines no longer actively recommend the traditional AR inhibitor bicalutamide for the treatment of mHSPC [3]
.

The new generation of AR inhibitor apatamide has better binding affinity to AR and better anti-tumor activity.
TITAN studies have shown [4] that compared to receiving simple ADT, apatamide + ADT treatment can quickly, deeply and lastingly reduce PSA, significantly To prolong the overall survival (OS) of mHSPC patients, a subgroup analysis showed that apatamide showed a greater benefit in patients with only bone metastases and low tumor burden
.

Figure 5.
TITAN study subgroup analysis The 36th European Association of Urology (EAU) Congress in 2021 updated the prognosis of patients with low tumor burden in the final results of the TITAN study receiving apatamide treatment
.

At baseline, the proportion of patients with low tumor burden was 37%.
The results showed that apatamide can significantly prolong the imaging progression-free survival (rPFS) of patients with low tumor burden, and the risk of imaging progression compared with placebo The group has decreased by 64%
.

From the results of OS, the use of apatamide for patients with low tumor burden reduces the risk of death by 47%.
After the effects of cross-entry are excluded, the benefit is more significant, and the risk of death can be reduced by 66%
.

Figure 6.
The results of rPFS and OS in the low tumor subgroups of TITAN study.
Therefore, this patient with low tumor burden was treated with apatamide + ADT.
One month later, the PSA decreased by 97%, showing that apatamide + ADT was fast and The effect of deeply reducing PSA levels is expected to achieve long-term survival
.

Apatamide is the first approved new AR inhibitor in China.
With the launch of Apatamide and the continuous optimization of medical reform policies, it is hoped that Apatamide, a powerful weapon, can be included in the national medical insurance as soon as possible, benefiting more Many prostate cancer patients! Review Expert 1 Introduction Professor Liu Xiuheng, Director of Surgery, Director of Urology, and Director of First Department of Surgery, Wuhan University People's Hospital, Doctor of Medicine, second-level professor, chief physician, doctoral supervisor, scholars studying in Japan, and visiting scholars to Europe and the United States for the first Hubei Province Medicine Leading talent, leader of the urology discipline, "Enders Medical Science and Technology Award" from the Department of International Cooperation of the Ministry of Health, academic positions and honors: • Standing Committee Member of the Asian Andrological Society • Specialized Endoscopy by the Endoscopy Professional Technology Evaluation Committee of the Ministry of Health of the People's Republic of China Executive Member of the Expert Committee • Member of the Endoscopy Group of the Chinese Medical Association Urology Association • Deputy Chairman of the Steering Committee of the Andrology Branch of the Chinese Medical Doctor Association • Standing Member of the Urology Branch of the Chinese Research Hospital Association • Member of the Minimally Invasive Group of the Chinese Medical Association • Straits Member of the Cross-Strait Urology Branch • Chairman of the Urology Branch of the Hubei Medical Doctor Association • Leader of the Minimally Invasive Department of Urology in Hubei Province Executive Editor of the Journal of Clinical Surgery "Chinese Journal of Urology Electronic Edition", "Chinese Journal of Organ Transplantation", "Zhonghua" Journal of Endocrinology, "Journal of Clinical Urology", "Journal of Organ Transplantation", "Journal of Microcirculation", "Selected Urology Collection" Scientific research achievements: presided over more than 10 key projects of the National Natural Science Foundation and the Provincial Science Foundation, and obtained provincial scientific and technological progress Award three, editor of three monographs, edited 8, in the preparation of graduate teaching materials
.

Published more than 150 papers and 50 SCI expert comments.
1 For all types of mHSPC, apatamide + ADT can achieve a faster PSA deep response [4], and studies have shown that the greater the decrease in PSA in the initial stage of mHSPC treatment, The longer the PSA progression-free survival time, the higher the 2-year and 5-year survival rates [5]
.

The first-line treatment of apatamide combination regimen can reduce the risk of secondary disease progression/death by 34%, and patients have a variety of effective sequential treatment options.
Among them, abiraterone as a follow-up treatment option can still significantly benefit patients[6- 7]
.

In this case, the treatment plan of apatamide + ADT was used, which was in line with the recommendations of domestic and foreign guidelines
.

I look forward to the efficacy and safety results of this patient after a longer follow-up, and look forward to the publication of the localized evidence of apatamide in the real world in China to better guide the clinical use of domestic patients
.

Review of Expert 2Professor Chen Zhiyuan, Deputy Director of the Department of Urology, Wuhan Xuemin Hospital, Medical Doctor, Chief Physician, Postgraduate Tutor, Italian Humanitas Visiting Scholar, Young Member of the Urology Branch of the Chinese Association of Research Hospitals, China Medical The Youth Committee of the Urological Health Promotion Branch of the Health Care International Exchange Promotion Association Member of the Urology Branch of the Hubei Provincial Physician Association Member of the Urological Endoscopy Professional Committee of the Hubei Provincial Society of Biomedical Medicine Expert Comment 2 About 70% of newly diagnosed prostate cancer patients in China have distant metastases , The occurrence of distant metastasis means that the patient’s survival time will be significantly shortened [8-9]
.

With the publication of more and more clinical trial data, new treatment methods based on ADT combined with new endocrine therapy drugs are constantly emerging, bringing more significant survival benefits to mHSPC patients
.

As a new type of AR inhibitor, apatamide can block the binding of androgens and receptors, and can also effectively block AR nuclear transport and AR binding to DNA.
Compared with simple ADT treatment, apatamide combined with ADT treatment The probability of group AR mutation is lower
.

In the guidelines for the diagnosis and treatment of prostate cancer issued by the Chinese Society of Clinical Oncology (CSCO) in 2020, apatamide + ADT has been used for the treatment of low tumor burden/high tumor burden mHSPC patients with double type I recommendation (type 1A evidence), which reflects This program has significant clinical benefits for patients at the mHSPC stage [10]
.

2021 (suppl 6; abstr 11).
[5].
Sato H, Narita S, Tsuchiya N, et al.
Impact of early changes in serum biomarkers following androgen deprivation therapy on clinical outcomes in metastatic hormone-sensitive prostate cancer.
BMC Urol.
2018;18(1):32.
[6].
Chi KN, et al.
ASCO-GU oral present 2020; abstract 5006.
[7].
Chi KN, Agarwal N, Bjartell A, et al.
Apalutamide for metastatic, castration -sensitive prostate cancer.
N Engl J Med.
2019;381(1):13-24.
[8].
Barata P, et al.
Treatment selection for men with metastatic prostate cancer who progress on upfront chemo-hormonal therapy[J].
The Prostate, 2018; 78(13): 1035-1041.
[9].
Hamdy FC, et al.
10-year outcomes after monitoring, surgery, or radiotherapy for localized prostate(15):1415-1424.
[10].
2020 CSCO Guidelines for Diagnosis and Treatment of Prostate Cancer Impact of early changes in serum biomarkers following androgen deprivation therapy on clinical outcomes in metastatic hormone-sensitive prostate cancer.
BMC Urol.
2018;18(1):32.
[6].
Chi KN, et al.
ASCO-GU oral present 2020 ; abstract 5006.
[7].
Chi KN, Agarwal N, Bjartell A, et al.
Apalutamide for metastatic, castration-sensitive prostate cancer.
N Engl J Med.
2019;381(1):13-24.
[8].
Barata P, et al.
Treatment selection for men with metastatic prostate cancer who progress on upfront chemo-hormonal therapy[J].
The Prostate, 2018; 78(13): 1035-1041.
[9].
Hamdy FC, et al.
10-year outcomes after monitoring, surgery, or radiotherapy for localized prostate(15):1415-1424.
[10].
2020 CSCO Guidelines for Diagnosis and Treatment of Prostate Cancer Impact of early changes in serum biomarkers following androgen deprivation therapy on clinical outcomes in metastatic hormone-sensitive prostate cancer.
BMC Urol.
2018;18(1):32.
[6].
Chi KN, et al.
ASCO-GU oral present 2020 ; abstract 5006.
[7].
Chi KN, Agarwal N, Bjartell A, et al.
Apalutamide for metastatic, castration-sensitive prostate cancer.
N Engl J Med.
2019;381(1):13-24.
[8].
Barata P, et al.
Treatment selection for men with metastatic prostate cancer who progress on upfront chemo-hormonal therapy[J].
The Prostate, 2018; 78(13): 1035-1041.
[9].
Hamdy FC, et al.
10-year outcomes after monitoring, surgery, or radiotherapy for localized prostate(15):1415-1424.
[10].
2020 CSCO Guidelines for Diagnosis and Treatment of Prostate Cancer [7].
Chi KN, Agarwal N, Bjartell A, et al.
Apalutamide for metastatic, castration-sensitive prostate cancer.
N Engl J Med.
2019;381(1):13-24.
[8].
Barata P,et al.
Treatment selection for men with metastatic prostate cancer who progress on upfront chemo-hormonal therapy[J].
The Prostate, 2018; 78(13): 1035-1041.
[9].
Hamdy FC, et al.
10-year outcomes after monitoring, surgery, or radiotherapy for localized prostate(15):1415-1424.
[10].
2020 CSCO Guidelines for Diagnosis and Treatment of Prostate Cancer [7].
Chi KN, Agarwal N, Bjartell A, et al.
Apalutamide for metastatic, castration-sensitive prostate cancer.
N Engl J Med.
2019;381(1):13-24.
[8].
Barata P,et al.
Treatment selection for men with metastatic prostate cancer who progress on upfront chemo-hormonal therapy[J].
The Prostate, 2018; 78(13): 1035-1041.
[9].
Hamdy FC, et al.
10-year outcomes after monitoring, surgery, or radiotherapy for localized prostate(15):1415-1424.
[10].
2020 CSCO Guidelines for Diagnosis and Treatment of Prostate Cancer Hamdy FC, et al.
10-year outcomes after monitoring, surgery, or radiotherapy for localized prostate(15):1415-1424.
[10].
2020 CSCO Guidelines for Diagnosis and Treatment of Prostate Cancer Hamdy FC, et al.
10-year outcomes after monitoring, surgery, or radiotherapy for localized prostate(15):1415-1424.
[10].
2020 CSCO Guidelines for Diagnosis and Treatment of Prostate Cancer