Long-term outcomes of a multicenter prospective observational study of active surveillance for early-stage prostate cancer: The PRIAS-JAPAN study.

Authors

null

Takuma Kato

Kagawa University, Kita-Gun, Japan

Takuma Kato , Ryuji Matsumoto , Akira Yokomizo , Yoichiro Tohi , Keiichiro Mori , Yoichi Fujii , Hiroshi Fukuhara , Takuma Sato , Junichi Inokuchi , Katsuyoshi Hashine , Shinichi Sakamoto , Mikio Sugimoto , Yoshiyuki Kakehi

Organizations

Kagawa University, Kita-Gun, Japan, Hokkaido University (Japan), Sapporo-Shi, Japan, Department of Urology, Harasanshin Hospital, Fukuoka, Japan, Jikei University School of Medicine, Tokyo, Japan, Tokyo University, Tokyo, Japan, Kyorin University, Mitaka, Japan, Tohoku University, Sendai, Japan, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan, Department of Urology, Chiba University Graudate School of Medicine, Chiba, Japan, Kagawa University, Kagawa, Japan

Research Funding

No funding sources reported

Background: Japan is participating in the Prostate cancer Research International: Active Surveillance (PRIAS) study as PRIAS-JAPAN since 2010. This study’s aim is to report the long-term outcomes of the PRIAS-JAPAN study initiated in 2010. Methods: Basic patient eligibility criteria were clinical stage ≤T2, PSA ≤10, PSA density (PSAD) <0.2, number of positive cores ≤2, and Gleason score (GS) ≤6. Those have been revised progressively since then, and since January 2021, for patients who underwent MRI fusion biopsy at the time of initiation or follow-up biopsy, PSA ≤ 20, PSAD < 0.25, and the number of positive cores ≤ 2 for GS3+3, and ≤ 6 for GS3+4. For the number of positive cores, the eligibility criteria were expanded to no limit for GS3+3 and no more than half of the total number of cores for GS3+4. PSA test every 3 months, rectal examination every 6 months, biopsy at 1, 4, 7, and 10 years, and every 5 years thereafter, and recommendation for secondary treatment after confirming pathological deterioration. Reevaluation of MRI within 3 months after diagnosis and targeted biopsy of the same site if there is a lesion suspicious for cancer, and recommends annual MRI when PSA-DT < 10 years and annual systematic biopsy if MRI cannot be performed. Results: As of the end of February 2023, 1204 patients were enrolled. The eligibility criteria were met in 1173 patients. The median age, PSA, PSAD, and number of positive cores were 69 years, 5.3, 0.15, 1, 844, and 309, respectively, and the clinical stage was T1c in 1,019 and T2 in 154 patients. The acceptance rates of re-biopsy at 1, 4, 7, and 10 years were 83.0%, 63.5%, 39.0%, and 20.3%, respectively, and the pathological deterioration rate at each re-biopsy was 29.4%, 29.7%, and 35.6%, respectively. The pathological deterioration rate at the time of each biopsy was 29.4%, 29.7%, 35.6%, and 18.1%, respectively.467 patients selected subsequent therapy and prostatectomy was the most frequently chosen treatment option. Conclusions: Pathological deterioration was observed in about 30% of patients at the time of biopsy, but the rate of biopsy decreased over time. Adherence to biopsy was considered necessary for the safe implementation of active surveillance. Clinical trial information: 2021-211.

Subsequence therapy / Clinical status
Prostatectomy220
EBRT123
Brachy therapy59
Hormone therapy65
Watchful waiting67
Lost follow110
Others / Unknown57
Other-cause death21

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Abstract Details

Meeting

2024 ASCO Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session A: Prostate Cancer

Track

Prostate Cancer - Advanced,Prostate Cancer - Localized

Sub Track

Therapeutics

Clinical Trial Registration Number

2021-211

Citation

J Clin Oncol 42, 2024 (suppl 4; abstr 322)

DOI

10.1200/JCO.2024.42.4_suppl.322

Abstract #

322

Poster Bd #

N13

Abstract Disclosures

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