Outcomes of the patients with pT0 on first protocol biopsy during active surveillance for early prostate cancer: From the PRIAS-JAPAN study.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 20-20
Author(s):  
Takuma Kato ◽  
Mikio Sugimoto ◽  
Yoshiyuki Kakehi ◽  
Akito Yamaguchi ◽  
Akira Yokomizo ◽  
...  

20 Background: We assessed the outcomes of the patients with pT0 on first protocol biopsy during active surveillance(AS) from the analysis Japanese cohort forming part of the Prostate Cancer Research International: Active Surveillance (PRIAS) study. Methods: PRIAS-JAPAN started in January 2010. 39 institutions are participating in this study. The inclusion criteria for the PRIAS study are as follows: clinical stage T1c/T2, PSA ≤ 10 ng/ml, PSA density (PSAD) < 0.2 ng/ml per milliliter, one or two positive biopsy cores, and Gleason score (GS) ≤ 6 at initial diagnostic biopsy.In this analysis, we defined the patients presenting no reclassification with cancer after first protocol biopsy as NR-CA group and the patients presenting no reclassification showing pT0 as NR-noCA group. We compared AS remaining rate, pathological outcomes in extra biopsy and second protocol biopsy at 4 years between two groups. Results: First protocol biopsy was performed on 514 patients. 191 patients were in NR-noCA group and 199 patients were in NR-CA group. Patients background of NR-noCA group was as follows: Median age was 68, median PSA was 5.6ng/ml, and median prostate volume was 38.4cc. T1c were in 183 and T2a were in 8. At the time of first protocol biopsy, there was no significant differences about PSA parameters and pathological factors between NR-noCA group and NR-CA group. Also, extra biopsy performing rate (NR-noCA group vs NR-CA group; 5.75% vs 7.53%) and implementation rate of second protocol biopsy at 4 years (75.6% vs 63.6%) showed no significant differences. On second protocol biopsy, number of cancer positive cores were significantly smaller and rate of pT0 was higher in NR-noCA group. After five years, both group showed comparable AS remaining rate (76.9 vs 75.3%). Thirty eight patients of NR-noCA group selected definitive therapy and surgery was the most frequently chosen treatment option. Conclusions: Although rate of pT0 on second biopsy was higher in NR-noCA group, there was no significant difference between both groups in AS remaining rate. The patients in NR-noCA group tended to choose surgery as a definitive therapy. Clinical trial information: UMIN000002874.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 118-118
Author(s):  
Mikio Sugimoto ◽  
Yoshiyuki Kakehi ◽  
Hiromi Hirama ◽  
Seiji Naito ◽  
Akito Yamaguchi ◽  
...  

118 Background: The Prostate Cancer Research International: Active Surveillance (PRIAS) study is a large international prospective observational AS study that commenced in 2006. Japan has participated in the study (PRIAS-JAPAN) since 2010, and recruitment remains ongoing. The objective of this study is to define clinical and pathological factors predicting reclassification at the time of 1-year repeat biopsy (re-Bx) based on a Japanese cohort forming part of the PRIAS study. Methods: The inclusion criteria for the PRIAS study are as follows: clinical stage T1c/T2, PSA ≤ 10 ng/ml, PSA density (PSAD) < 0.2 ng/ml per milliliter, one or two positive biopsy cores, and Gleason score (GS) ≤ 6 at initial diagnostic biopsy. Baseline clinical characteristics and prostate-specific antigen doubling time (PSADT) at the time of re-Bx were analyzed via multivariate logistic regression with respect to reclassification on the 1-year re-Bx. Results: A total of 711 patients were enrolled in PRIAS-JAPAN by September 2016. Of these, 409 underwent re-Bx at 1-year. The re-Bx acceptance rate was 83.3%. A total of 122 (29.8%) was reclassified whereas 150 (36.7%) had no cancer. Older age, a higher PSAD, a higher positive core rate, and a shorter PSADT were significant predictors of reclassification. Among them, the positive core rate was the strongest predictor for pathological reclassification at 1-year after starting AS. The AS remaining rates at 1, 2, 3, 4 and 5 years were 93.9%, 70.6%, 65.7%, 60.0% and 49.5% respectively Conclusions: An interim analysis of a Japanese AS cohort participating in PRIAS revealed that the positive core rate was strongly associated with reclassification at the 1-year re-Bx. Clinical trial information: UMIN000002874. [Table: see text]


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Rashid K. Sayyid ◽  
Laurence Klotz ◽  
John Z. Benton ◽  
Merry Ma ◽  
Phillip Woodruff ◽  
...  

Introduction: Active surveillance (AS) is increasingly used for favorable intermediate-risk (FIR) prostate cancer (PCa). Our objective was to determine oncological and sociodemographic predictors of deferred definitive therapy and decision for radical prostatectomy (RP) vs. radiotherapy (XRT). Methods: The Surveillance, Epidemiology, and End Results Prostate with Watchful Waiting database was used to identify all FIR PCa diagnosed between 2010 and 2015 opting for AS for at least one year following diagnosis. We sought to determine predictors of treatment and treatment type using multivariable logistic regression. Results: A total of 20 334 patients were identified. An annual decrease in incident FIR patients managed initially with AS between 2010 (4061) and 2015 (2947) was noted (p for trend <0.001); 17 895 (88.0%) patients underwent deferred RP and/or XRT. Patients with higher baseline cancer volume and clinical stage were significantly more likely to discontinue AS. Patients of higher socioeconomic status were more likely to undergo deferred therapy, with increased odds for XRT over RP. African American patients had lower odds of undergoing definitive intervention (odds ratio 0.83, p=0.030) and were significantly more likely to opt for XRT. Oncological characteristics leading to FIR classification influenced treatment choice at the time of deferred intervention: XRT was treatment of choice in 86.3% and 86.0% of Gleason group 2 and PSA 10–20 FIR patients, respectively; 96.1% of treated cT2b-c FIR patients opted for RP. Conclusions: Most FIR PCa patients initially managed with AS eventually undergo deferred definitive therapy, with choice of treatment significantly influenced by patients’ baseline oncological and sociodemographic characteristics.


2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 19-19
Author(s):  
Aaron Katz ◽  
Andrew S Fontes ◽  
Kaitlin E. Kosinski

19 Background: There is currently no consensus on how active surveillance should be utilized in order to optimize the benefit of patients with prostate cancer (PCa) to prevent overtreatment. Our institution’s protocol, known as Active Holistic Surveillance (AHS) integrates MRI screening in the place of serial biopsies. Nutritional supplements and lifestyle changes are also suggested in order to provide a holistic way to reduce progression. We look to compare definitive treatment rates of our cohort on AHS to other publications in the literature. Methods: A retrospective chart review was conducted on 200 patients placed on active surveillance for low and low-intermediate risk PCa under D’Amico criteria from February 2002 to July 2015. Enrollment criteria was defined by clinical stage (T1c), PSA under 20 ng/mL, diagnosis of a Gleason 6 or Gleason 7 with a tumor volume of >50%, and a PSA doubling time of greater than 1 year. The main objective of the study was to evaluate the rate of patients discontinuing AHS to receive definitive therapy and reasons for leaving our AHS protocol. Results: 200 patients (age 44-84 years) have a median follow-up of 40 months (range 4-161). A total of 24 out of 200 patients (12%) moved on to definitive treatment. For patients on AHS before 2010 until 2012, the rates of definitive treatment were 0%. In 2013, 8 patients (4%) received definitive treatment. In 2014, 12 patients (6%) received definitive treatment. In 2015, 4 patients (2%) received definitive treatment to date.The average treatment rate per year is 4%. Reasons for 24 patients discontinuing AHS included biopsy progression (16.67%), MRI progression (29.17%), MRI progression with biopsy confirmation (29.17%), patient preference (20.83%), and 1 patient was deceased due to an unrelated illness (4.17%). Conclusions: Low rates of discontinuation compared to other publications in the literature demonstrate that AHS can be a successful protocol for low-risk and low-intermediate risk PCa patients, and that a holistic approach can be beneficial to active surveillance patients.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17616-e17616
Author(s):  
Yoichiro Tohi ◽  
Takuma Kato ◽  
Ryuji Matsumoto ◽  
Nobuo Shinohara ◽  
Akira Yokomizo ◽  
...  

e17616 Background: Active surveillance(AS) is the strategy to avoid the overtreatment for favorable prostate cancer. For safer AS protocol execution, repeat protocol biopsy is essential in evaluating cancer aggressiveness accurately. However, some men on AS refuse repeat protocol biopsy because of burdens on biopsy. We aimed to assess the complications of prostate biopsy and the impact of complications after diagnostic biopsy on repeat protocol biopsy from the analysis Japanese cohort forming part of the Prostate cancer Research International: Active surveillance (PRIAS) study. Methods: PRIAS-JAPAN started in January 2010, 39 institutions are participating in this study. Men are prospectively followed and repeat protocol biopsy are planned at 1 year and 4 years thereafter, or if prostate specific antigen-doubling time is < 10 years. Data was collected on the complications such as infection, hematuria, hematospermia, pain, and antibiotics, and approach of biopsy, retrospectively. We compared the complications in diagnostic biopsy between repeat biopsy acceptance group and repeat biopsy non-acceptance group at 1 year. Results: From 2010 to 2018, 862 men with low-risk prostate cancer were prospectively enrolled in PRIAS-JAPAN. 794 men (92%) actually proceeded to protocol at 1 year. Of the 794 men, repeat protocol biopsy non-acceptance rate at 1 year was 18.4%(146 men). According to differences in the complications of diagnostic biopsy, hematuria(p = 0.003) and pain(p < 0.001) rate were significantly higher in repeat biopsy non-acceptance group, but infection(p = 0.105) and hematospermia(p = 0.224). Approach of biopsy(p = 0.651) was not different in two groups. Conclusions: Hematuria and pain in diagnostic biopsy were significantly more frequent in repeat biopsy non-acceptance group. Our study supports the importance of adequate explanation and management of the complications at biopsy to improve the rate of protocol biopsy acceptance. [Table: see text]


2020 ◽  
Vol 77 (4) ◽  
pp. 501-507 ◽  
Author(s):  
Gregory T. Chesnut ◽  
Emily A. Vertosick ◽  
Nicole Benfante ◽  
Daniel D. Sjoberg ◽  
Jonathan Fainberg ◽  
...  

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 99-99
Author(s):  
K. Saito ◽  
K. Kihara ◽  
N. Numao ◽  
H. Masuda ◽  
T. Kijima ◽  
...  

99 Background: Focal therapy for prostate cancer could be a minimally invasive therapeutic option with the preservation of genitourinary function to reduce treatment associated complication under the appropriate selection of patients. We have reported the good predict ability to unilateral prostate cancer by extended prostate biopsy combined with transperineal and transrectal approaches (Eur Urol supple, 2009). Among the candidate ablative, brachytherapy which has been proved as a definitive therapy and applied worldwide has been thought to have potential for focal ablation due to its ability of dose and location adjustment by seed implantation under real-time monitoring. Based on the findings, focal therapy with hemiablation using I-125 seed implantation has been started in our instituion. The aim of study is to describe the initial experience of focal therapy for patients selected by extended biopsy and MRI findings. Methods: The eligible criteria for focal therapy to prostate cancer are as follows. Clinical stage is T2a or less. The positive cores of cancer are proven within unilateral lobe by extended prostate biopsy. There was no cancerous lesion in contralateral lobe by MRI. Gleason score in positive cores was 3 + 4 or less. Maximum cancer length was less than 5 mm. PSA value is less than 10 ng/mL. On the treatment, I-125 seeds were implanted to ablate the unilateral lobe with 160 Gy of the prescription dose. The protocol has been approved by the institutional ethics commit. Results: At present, 3 patients were enrolled in this study and underwent focal therapy with written informed consents. In all three cases, I-125 seeds implanted (number od seeds: 43, 39, and 37) to unilateral lobe without severe acute complication such as acute urinary retention. In one case that has been followed over 3months among the initial three cases, PSA values decreased to 2.07 mg/ml at 3 months after the seed implantation. Conclusions: To our knowledge, this is the first report about focal therapy by brachytherapy with hemiablative technique. In our initail experience, severe treatment associated complication has not been observed. No significant financial relationships to disclose.


Sign in / Sign up

Export Citation Format

Share Document