Nadir Prostate-specific Antigen Value Research Articles

Remission Depth in Metastatic Hormone-Sensitive Prostate Cancer Is Associated With Prognosis in Patients With Initial Prostate-Specific Antigen Values Above 100 Ng/ML.

Recently, new drugs have caused a paradigm shift in the treatment of metastatic hormone-sensitive prostate cancer (HSPC). Meanwhile, research has identified several prognostic factors of metastatic HSPC. The present study focused on remission depth in metastatic HSPC and evaluated its association with remission depth. We analyzed 427 patients diagnosed with metastatic HSPC with serum initial prostate-specific antigen (PSA) > 100 ng/ml. The nadir serum PSA value was used as a marker of remission depth for each duration to castration resistanceby using receiver operating characteristic (ROC) curves.Cox proportional hazards regression was used to assess for any correlation of progression-free survival (PFS) and overall survival (OS) with the nadir PSA level. The cut-off value for the nadir PSA level per time to castration resistance (TTCR) at three, five, seven, and nine years was calculated. The nadir PSA value alone was able to predict prognosis because of its high sensitivity, high specificity, and high AUC in ROC analysis. The nadir PSA level can be an independent prognostic marker not only for TTCR but also for OS on multivariate analysis. We identified the cut-off value for nadir PSA per TTCR period in patients with metastatic HSPC. The nadir PSA value alone can predict prognosis; this demonstrates utility in routine clinical practice due to its simplicity and accuracy.

Prognostic significance of nadir PSA value and time to nadir PSA in patients with metastatic castration-naive prostate cancer receiving first-line hormonotherapy.

The current study aimed to evaluate the effect of the time duration to reach the lowest prostate-specific antigen (PSA) from the onset of first-line hormonal treatment (time to nadir PSA, TTNpsa) on survival in castration-naive metastatic prostate cancer (CN-MPC) patients. Eighty patients who had PSA response >80% with first-line hormonal therapy (luteinizing hormone-releasing hormone, LH-RH analog +/- bicalutamide) were included in this study. Under androgen deprivation therapy (ADT), a significant positive correlation was found between TTNpsa, nadir PSA (Npsa) duration, and progression-free survival (PFS) ( p < 0.001) and overall survival (OS) ( p < 0.001). There was no correlation between TTNpsa and Npsa duration. TTNpsa and Npsa durations were independently correlated with PFS and OS. In patients with TTNpsa value ≥19 weeks, the median PFS was 126 (95% CI, 68-184) weeks compared with TTNpsa <19-week group in which the median PFS was 44 (95% CI, 26-62) weeks ( p = 0.033). In patients with TTNpsa value ≥19 weeks, the median OS was 242 (95% CI, 169-315) weeks compared with TTNpsa <19-week group in which the OS was 156 (95% CI, 89-223) weeks ( p = 0.018). The median nadir PSA value was 1 ng/mL. The median PFS was significantly longer in the patient group with ≤1 ng/mL (137 weeks, 95% CI, 50-224) compared with the group with >1 ng/mL (41 weeks, 95% CI, 34-48) ( p < 0.001). The median OS was significantly longer in the patient group with nadir PSA ≤1 ng/mL (296 weeks, 95% CI, 220-272) compared to the group with >1 ng/mL (131 weeks, 95% CI, 84-178) ( p = 0.002). In patients with nadir PSA ≤1 ng/mL ( n = 40), there was no relationship between TTNpsa and Npsa duration with both PFS and OS. However, in patients with nadir PSA >1 ng/mL ( n = 40) subgroup, there was a significant positive correlation between TTNpsa and PFS, and OS ( p < 0.001, P = 0.016, respectively). In CN-MPC who received first-line ADT, especially in the group with the nadir PSA value >1 ng/mL, the duration of TTNpsa was positively correlated with PFS and OS.

Prostate-Specific Antigen Bounce after 125I Brachytherapy Using Stranded Seeds with Intraoperative Optimization for Prostate Cancer.

Simple SummaryOur study investigated clinical features of prostate-specific antigen (PSA) bounce in patients undergoing brachytherapy. PSA bounce is common and discriminating between large bounces and biochemical failures is very difficult. Therefore, we suggest important points to discriminate between large bounces and biochemical failures. In addition, we aimed to examine the clinical features and details of PSA bounce in patients receiving brachytherapy.Prostate-specific antigen (PSA) bounce is common in patients undergoing 125I brachytherapy (BT), and our study investigated its clinical features. A total of 100 patients who underwent BT were analyzed. PSA bounce and large bounce were defined as an increase of ≥0.2 and ≥2.0 ng/mL above the initial PSA nadir, respectively, with a subsequent decline without treatment. Biochemical failure was defined using the Phoenix definition (nadir +2 ng/mL), except for a large bounce. With a median follow-up of 49 months, 45% and 7% of the patients experienced bounce and large bounce, respectively. The median time to bounce was 24 months, and the median PSA value at the bounce spike was 1.62 ng/mL, a median raise of 0.44 ng/mL compared to the pre-bounce nadir. The median time to bounce recovery was 4 months. The post-bounce nadir was obtained at a median of 36 months after low-dose-rate BT. On univariate analysis, age, the PSA nadir value at 2 years, and prostate volume were significant factors for PSA bounce. The PSA nadir value at 2 years remained significant in multivariate analysis. We should carefully monitor young patients with high prostate volume having a >0.5 PSA nadir value at 2 years for PSA bounce.

PD22-09 DISTINGUISHING BETWEEN PROSTATE SPECIFIC ANTIGEN BOUNCE AND BIOCHEMICAL RECURRENCE FOLLOWING STEREOTACTIC BODY RADIOTHERAPY FOR PROSTATE CANCER

You have accessJournal of UrologyCME1 May 2022PD22-09 DISTINGUISHING BETWEEN PROSTATE SPECIFIC ANTIGEN BOUNCE AND BIOCHEMICAL RECURRENCE FOLLOWING STEREOTACTIC BODY RADIOTHERAPY FOR PROSTATE CANCER Ashley Monaco, Jessica Sommer, Jordan Mendelson, Jonathan Haas, Anthony Corcoran, and Aaron Katz Ashley MonacoAshley Monaco More articles by this author , Jessica SommerJessica Sommer More articles by this author , Jordan MendelsonJordan Mendelson More articles by this author , Jonathan HaasJonathan Haas More articles by this author , Anthony CorcoranAnthony Corcoran More articles by this author , and Aaron KatzAaron Katz More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002564.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: While prostate specific antigen (PSA) bounce following radiation therapy for prostate cancer (PCa) treatment is well established, the parameters to predict this occurrence and differentiate it from biochemical recurrence (BCR) following stereotactic body radiotherapy (SBRT) are unknown. The purpose of this study is to investigate associations between pre-treatment and post-treatment variables among patients experiencing PSA bounce, BCR, or neither following SBRT. METHODS: An IRB-approved PCa database was reviewed for patients who underwent primary SBRT. Patients with less than 18 months of follow-up or were missing >3 PSA measurements following SBRT were excluded. Patients were divided into outcome groups experiencing PSA bounce, BCR, or neither. PSA bounce was defined as a rise of >0.2 ng/mL over the pre-rise nadir followed by a decline without intervention. BCR was defined by Phoenix criteria. Pre-treatment and post-treatment characteristics were analyzed between groups. Results that were significant when comparing PSA bounce to BCR were then analyzed in a multivariate logistic regression model to determine predictors for PSA bounce. RESULTS: We analyzed 170 men with a median age of 72 (52-87) years with an average follow-up time of 75 + 21 months, of which 28 (16%) experienced PSA bounce and 42 (25%) had BCR (Table 1). Pre-treatment D’Amico and Capra risk, Gleason group, PSA, prostate volume, prostate density and post-treatment PSA velocity were not associated with PSA bounce when compared to BCR or non-BCR/bounce cohorts. Compared to those who did not experience PSA bounce/BCR, those with PSA bounce were younger (p <.05), had lower PSA doubling time (p <.001), and took longer to reach PSA nadir (p <.001). Compared to BCR group, men with PSA bounce had lower PSA nadir and took longer to reach nadir, both of which were significant predictors for PSA bounce (OR: 4.3, p <.05; OR: 0.90, p <.001). PSA bounce occurred significantly earlier than BCR (16 vs. 33 months; p <.001). CONCLUSIONS: While there is overlap among patients who experience PSA bounce or BCR following SBRT, the timing of which the PSA rise occurs, the PSA nadir value, and the time to PSA nadir are useful variables in the management of a rising PSA in patients following SBRT. Source of Funding: Department of Urology, NYU Langone Hospital – Long Island © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e407 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ashley Monaco More articles by this author Jessica Sommer More articles by this author Jordan Mendelson More articles by this author Jonathan Haas More articles by this author Anthony Corcoran More articles by this author Aaron Katz More articles by this author Expand All Advertisement PDF DownloadLoading ...

Comparison of Testosterone and Prostate-Specific Antigen Nadir Value between Castration Resistant Prostate Cancer and Non-Castration Resistant Prostate Cancer Patients after Androgen Deprivation Therapy - A Single Center Study in Indonesia

BACKGROUND: Prostate cancer is the second most commonly occurring cancer in adult males worldwide. Androgen deprivation therapy (ADT) is the mainstay treatment for patients with advanced prostate cancer. However, despite the low testosterone level (indicative of ADT success), most advanced prostate cancers progress into an androgen unresponsive or castrate resistant state; such cases are defined as castrate-resistant prostate cancer (CRPC) and were associated with worse outcomes and more rapid prostate cancer progression. This study aimed to compare the value of nadir testosterone level and nadir PSA in CRPC and non-CRPC patients who received ADT. AIM: This study was aimed to compare value of nadir testosterone level and nadir PSA in CRPC and non-CRPC patients who received ADT. METHODS: Prostate cancer patients receiving ADT in dr. Hasan Sadikin Bandung General Hospital in September 2018–September 2020 without previous history of CRPC and surgical castration, and prostate cancer with histopathological confirmation were included to the study. The patients prior had received complete blockade ADT with luteinizing hormone agonist (LHRH) goserelin acetate 10.8 mg injected subcutaneously per 3 months and oral anti-androgen bicalutamide 50 mg orally daily. Testosterone and PSA levels were assessed on 1st, 3rd, 6th, and 12th month. Patients then were grouped into CRPC group and non-CRPC group and further subdivided according testosterone levels (&lt;20 and 20–500 ng/dL). Paired t-test and Chi-square test were used to analyze statistical difference (p &lt; 0.05 deemed significant). RESULTS: Significantly higher baseline PSA (p = 0.002) and nadir PSA (p = 0.013) were found on the CRPC group. Nadir testosterone in CRPC group was higher than non-CRPC group but statistically insignificant (p = 0.849). Time to CRPC is faster in nadir testosterone 20–50 ng/dl group than in &lt;20 ng/dl group but statistically insignificant (p = 0.837). CONCLUSION: Prostate cancer patients who had high baseline PSA and nadir PSA after ADT need a longer follow-up time and more frequent testing of the testosterone and PSA values. It can predict the incidence of CRPC and to ensure that prostate cancer patients receive adequate therapy.

Metastasic Prostate Cancer: Predictive Factors of Earlier Progression to Castration-Resistance.

Prostate cancer (PCa) can progress to the lethal phenotype of metastatic castration resistance (mCRPC), either from initially localized disease or de novo metastatic cancer. New drugs improving overall survival are now the cornerstone of treatment. Nevertheless, there are no defined sequences or established timing to initiate or discontinue treatments; besides, not all patients end in CRPC or reach this stage at the same time. To evaluate characteristics of patients who progress to mCRPC and establish an association with time to mCRPC diagnosis. Retrospective, descriptive and observational study of 35 mCRPC patients, performed from 2013 to 2017. Variables analyzed were age, Gleason score and prostate-specific antigen (PSA) at diagnosis, initial stage, response time to androgen deprivation therapy (ADT), PSA nadir on ADT and time until mCRPC progression. Statistical analysis comparing variables with time to mCRPC diagnosis was performed. Average age at diagnosis was 68.9 years; PSA values were classified into 3 categories: <20 ng/ml, 20-50 and >50. Gleason score was 7 in 50%, and 8-9 in the rest. Tumor was initially localized in 46% of the patients and metastatic in the rest. PSA nadir on ADT was <1 ng/ml in 67%. Average time to androgen deprivation: 5.5 years, time to mCRPC diagnosis: 6.9 years. Significant associations between time to mCRPC and time of androgen deprivation, PSA nadir during ADT and stage at diagnosis were found. Response time to ADT <1 year, PSA nadir value >5 ng/ml during treatment and metastatic stage at diagnosis were associated with earlier progression to mCRPC.

Prognostic factors, efficacy, and toxicity of involved-node stereotactic body radiation therapy for lymph node oligorecurrent prostate cancer : An investigation of 117 pelvic lymph nodes.

The optimal radiotherapy regimen is not yet defined in the setting of oligorecurrent prostate cancer (oligorPC). There is evidence of high variability in treatment protocols among different centers worldwide, and no international consensus guidelines on treatment volumes, radiation schedules, and techniques. The purpose of the present retrospective study is to evaluate the efficacy and safety of involved-pelvic-node stereotactic body radiotherapy (SBRT) for oligorPC. Patients with pelvic node oligorPC following primary surgery, radical radiotherapy, or salvage radiotherapy for biochemical or local relapse of prostate cancer who underwent involved-node SBRT with biological effective dose (BED) > 100 Gy, with or without concurrent and adjuvant androgen deprivation therapy (ADT), were retrospectively evaluated. Biochemical progression-free survival (bPFS), distant progression-free survival (DPFS), overall survival (OS), possible prognostic factors, and toxicity outcomes were investigated. From November 2012 to December 2019, 74patients fitted the selection criteria. Atotal of 117 lesions were treated. Median follow-up was 31months (range 6-89). Concurrent ADT was administered in 58.1% of patients. The 1‑year, 2‑year, and 3‑year DPFS was 77%, 37%, and 19%, respectively; the 1‑year, 2‑year, and 3‑year OS was 98%, 98%, and 95%, respectively. The presence of asingle target lesion was associated with astatistically significant impact on OS. No in-field recurrence occurred. Patients who reached early prostate-specific antigen (PSA) nadir (< 3months after SBRT) had alower 3‑year survival (p = 0.004). The value of PSA nadir after SBRT and the time between primary treatment and SBRT had an impact on bPFS. Concomitant ADT was associated with improved DPFS. No acute or early late (> 6months) genitourinary and gastrointestinal adverse events of any grade were reported, albeit with relatively short median follow-up. SBRT is asafe and effective treatment for oligorPC, with a100% local control rate in our series. It is not possible to clearly assess the opportunity to postpone ADT prescription in patients with two or more nodal metastases. The number of secondary lesions, time-to-nadir PSA, PSA nadir value, and the time interval between primary treatment and SBRT were identified as prognostic factors. Future prospective randomized studies are desirable to better understand the still open questions regarding the oligorecurrent prostate cancer state.

Role of PSA Kinetics in Hormone-refractory Prostate Cancer.

To demonstrate the predictive effect of PSA derivatives and time markers that is prostate-specific antigen (PSA) doubling time (PSADT) and PSA velocity (PSAV) on survival in men with hormone-refractory prostate cancer (HRPCa). Descriptive, analytical study. Department of Urology, Erciyes University, Faculty of Medicine, Kayseri, Turkey, between 2012 and 2020. One hundred patients, who were treated with prostate cancer, were subjected. The PSA values were noted, nadir PSA values were detected, times to nadir PSA, HRPCa, and follow-up times were recorded. PSADT and PSAV were calculated. The relationships between the groups were analyzed. Kaplan-Meier curves were used to estimate overall survival between the groups. The patients were grouped according to the mean PSADT, median PSAV, median nadir PSA, and mean time to HRPCA. The survival of those with high PSADT, low PSAV and low nadir PSA were found to be significantly longer (p=0.006, p<0.001, p<0.001). High PSAV was also associated with significantly increased PSA, nadir PSA and death (p<0.001, p=0.47, and p<0.001, p=0.52, respectively). The survival of those with a longer time to HPRCa was found to be significantly longer (p<0.001). There was no statistically significant difference in terms of survival between patients who received chemotherapy after HRPCa and those who did not (p=0.477). PSAV (p=0.007 HR: 1.004 95% CI: 1.001 - 1.007), bone metastasis at diagnosis (p=0.001 HR: 0.357 95% CI: 0.197 - 0.645) and time to HRPCa development (p=0.001 HR: 0.936 95% CI: 0.900 - 0.974) were significantly effective to the survival. Conclusion:PSADT, PSAV, and nadir PSA serve as independent prognostic markers for survival in patients with HRPCa. These three PSA derived calculation products, with the help of other parameters, could work as prognostic factors, and help clinicians predict survival in men with HRPCa. Key Words: PSA kinetics, Hormone-refractory prostate cancer, Survival, Prognostic factors.

Biochemical recurrence after radical prostatectomy according to nadir prostate specific antigen value.

The hypersensitive prostate specific antigen (PSA) test can measure in 0.01 ng/mL units, and its efficacy for screening after radical prostatectomy (RP) has been reported. In this study, we assessed patients who underwent RP to evaluate whether the nadir value affects biochemical recurrence (BCR). From 1995 to 2014, patients classified as N0 who had negative resection margins and a nadir PSA of less than 0.2 ng/mL were evaluated. The characteristics, pathological outcomes, PSA after RP, and BCR were assessed. A total of 1483 patients were enrolled. Among them, 323 (21.78%) patients showed BCR after RP. The mean age of the BCR group was 63.86±7.31 years, and while that of the no-recurrence group was 64.06±6.82 years (P = 0.645). The mean preoperative PSA of the BCR group was 9.75±6.92 ng/mL and that of the no-recurrence group was 6.71±5.19 ng/mL (P < 0.001). The mean time to nadir (TTN) in the BCR group was 4.64±7.65 months, while that in the no-recurrence group was 7.43±12.46 months (P < 0.001). The mean PSA nadir value was 0.035±0.034 ng/mL in the BCR group and 0.014±0.009 ng/mL in the no-recurrence group (P < 0.001). In multivariable Cox regression analyses, Gleason score, positive biopsy core percentages, minimal invasive surgery, nadir PSA value, and TTN were independently associated with BCR. The mean BCR occurred at 48.23±2.01 months after RP, and there was a significant difference in BCR occurrence according to the nadir PSA value (P < 0.001). A high PSA nadir value and short TTN may predict the risk of BCR after successful RP, aiding the identification of candidates for adjuvant or salvage therapies after RP.

Prognostic factors in postoperative radiotherapy for prostate cancer - tertiary center experience.

BackgroundThe aim of the study was to analyse the prognostic factors in postoperative prostate cancer irradiation and develop a nomogram for disease-free survival (DFS).Patients and methodsThis retrospective study included 236 consecutive prostate cancer patients who had radical prostatectomy followed by radiotherapy (RT) at a single tertiary institution between 2009 and 2014. The main outcome was DFS analysed through uni- and multivariable analysis, Kaplan-Meier curves, log-rank testing, recursive partitioning analysis, and nomogram development.ResultsThe median follow up was 62.3 (interquartile range [IQR] 38.1–79) months. The independent clinical factors associated with increased risk of recurrence or progression in the multivariate analysis (MVA) were prostate-specific antigen (PSA) level before RT, pT3 characteristic, and local failure as salvage indication. The value of PSA nadir had a significant impact on the risk of biochemical failure. Biochemical control and DFS were significantly different depending on treatment indication (p < 0.0001). The recursive partitioning analysis highlighted the importance of the PSA level before RT, Gleason Grade Group, PSA nadir, and local failure as a treatment indication. Finally, the nomogram for DFS was developed and is available online at https://apps.konsta.com.pl/app/prostate-salvage-dfs/.ConclusionsThe Pre-RT PSA level, pT3 characteristic and local failure as salvage indication are pivotal prognostic factors associated with increased risk of recurrence or progression. The Gleason grade group of 4–5 and PSA nadir value allow for further risk stratification. The treatment outcomes in postoperative prostate cancer irradiation are significantly different depending on treatment indication. An online nomogram comprising of both pre-treatment and current data was developed allowing for visualization of changes in prognosis depending on clinical data.

Favorable prognosis of patients who received adjuvant androgen deprivation therapy after radiotherapy achieving undetectable levels of prostate-specific antigen in high- or very high-risk prostate cancer.

To determine the prognostic significance of long-term adjuvant androgen deprivation therapy (A-ADT) over 1 year in achieving undetectable levels of prostate-specific antigen (PSA) less than 0.001 ng/mL in prostate cancer patients with high- or very high-risk prostate cancer who underwent radiotherapy (RT). A total of 197 patients with prostate cancer received RT, with a follow-up of ≥12 months. Biochemical failure was defined as PSA ≥nadir + 2 ng/mL after RT. We analyzed clinical outcomes, including survival, failure patterns, and prognostic factors affecting outcomes. Biochemical failure-free survival (BCFFS), clinical failure-free survival, distant metastasis-free survival, cancer-specific survival, and overall survival (OS) rates at 5 years were 91.1%, 95.4%, 96.9%, 99.5%, and 89.1%, respectively. Administration of long-term A-ADT significantly predicted favorable BCFFS (p = 0.027) and OS (p < 0.001) in multivariate analysis. Nadir PSA ≤0.001 ng/mL was an independent prognostic factor for BCFFS (p = 0.006) and OS (p = 0.021). The use of long-term A-ADT significantly affected nadir PSA ≤0.001 ng/mL (p < 0.001). The patients with A-ADT for 1 year or longer had better BCFFS or OS than those for less than 1 year or those without A-ADT (p < 0.001). The best prognosis was demonstrated in patients treated with long-term A-ADT and nadir PSA ≤0.001 ng/mL in BCFFS (p < 0.001). The addition of long-term A-ADT over 1 year to RT demonstrated good treatment outcomes in patients with locally advanced prostate cancer. Achieving a nadir PSA value ≤0.001 ng/mL using combination therapy with RT and A-ADT is a powerful clinical predictor of treatment outcomes.

PD48-04 THE ASSOCIATION BETWEEN NADIR PROSTATE SPECIFIC ANTIGEN VALUE AND BIOCHEMICAL RECURRENCE AFTER RADICAL PROSTATECTOMY

You have accessJournal of UrologyProstate Cancer: Detection & Screening V (PD48)1 Apr 2020PD48-04 THE ASSOCIATION BETWEEN NADIR PROSTATE SPECIFIC ANTIGEN VALUE AND BIOCHEMICAL RECURRENCE AFTER RADICAL PROSTATECTOMY Jae Hoon Chung*, Seong Soo Jeon, Jae Yong Jeong, Minyong Kang, Hyun Hwan Sung, Hwang Gyun Jeon, Byong Chang Jeong, Seong Il Seo, and Hyun Moo Lee Jae Hoon Chung*Jae Hoon Chung* More articles by this author , Seong Soo JeonSeong Soo Jeon More articles by this author , Jae Yong JeongJae Yong Jeong More articles by this author , Minyong KangMinyong Kang More articles by this author , Hyun Hwan SungHyun Hwan Sung More articles by this author , Hwang Gyun JeonHwang Gyun Jeon More articles by this author , Byong Chang JeongByong Chang Jeong More articles by this author , Seong Il SeoSeong Il Seo More articles by this author , and Hyun Moo LeeHyun Moo Lee More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000942.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The hypersensitive prostate specific antigen (PSA) test can measured in 0.01 ng/mL units, and its efficacy for screening after radical prostatectomy (RP) has been reported. In this study, we assessed the patients who underwent RP to evaluate whether the nadir value affects biochemical recurrence (BCR). METHODS: From 1995 to 2012, the patients who had N0, negative resection margin and nadir PSA of less than 0.2 ng/mL were evaluated. The characteristics, pathological outcomes, PSA after RP and BCR were assessed. RESULTS: A total of 1483 patients were enrolled. Among them, 323 (21.78%) patients showed BCR after RP. The mean age of BCR group was 63.86±7.31 years and in no-recurrence group was 64.06±6.82 years (p=0.645) The mean preoperative PSA of the BCR group was 9.75 ± 6.92 ng/mL and the no-recurrence group was 6.71 ± 5.19 ng/mL (p<0.001). The mean time to nadir in BCR group was 4.64±7.65 months and 7.43±12.46 months in no-recurrence group (p<0.001). In BCR group, mean PSA nadir value was 0.035±0.034 ng/mL and mean nadir value in no-recurrence group was 0.014±0.009 ng/mL (p<0.001) (Table 1). In multivariable Cox regression analyses, gleason score, positive biopsy core percentages, American Society of Anesthesiologists score 5, minimal invasive surgery, nadir PSA value and time to nadir after surgery was associated BCR, independently (Table 2). The mean BCR occurred at 48.23 ± 2.01 months after RP, and there was a significant difference in BCR occurrence according to nadir PSA value (p <0.001) (Figure 1). CONCLUSIONS: PSA nadir value predicts the risk of BCR after RP. Higher nadir value may identify candidates for adjuvant or salvage therapies. Source of Funding: none © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e994-e995 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Jae Hoon Chung* More articles by this author Seong Soo Jeon More articles by this author Jae Yong Jeong More articles by this author Minyong Kang More articles by this author Hyun Hwan Sung More articles by this author Hwang Gyun Jeon More articles by this author Byong Chang Jeong More articles by this author Seong Il Seo More articles by this author Hyun Moo Lee More articles by this author Expand All Advertisement PDF downloadLoading ...

Ten-Year Results From a Phase II Study on Image Guided, Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost in High-Risk Prostate Cancer

PurposeThere is no consensus on how to treat high-risk prostate cancer, and long-term results from hypofractionated radiation therapy are lacking. We report 10-year results after image guided, intensity modulated radiation therapy with hypofractionated simultaneous integrated boost and elective pelvic field. Methods and MaterialsBetween 2007 and 2009, 97 consecutive patients with high-risk prostate cancer were included, treated with 2.7 to 2.0 Gy × 25 Gy to the prostate, seminal vesicles, and elective pelvic field. Toxicity was scored according to Radiation Therapy Oncology Group criteria and biochemical disease-free survival (BFS) defined by the Phoenix definition. Patients were subsequently divided into 3 groups: high risk (HR; n = 32), very high risk (VHR; n = 50), and N+/s–prostate-specific antigen (PSA) ≥100 (n = 15). Differences in outcomes were examined using Kaplan-Meier analyses. ResultsBFS in the patients at HR and VHR was 64%, metastasis-free survival 80%, prostate cancer-specific survival 90%, and overall survival (OS) 72%. VHR versus HR subgroups demonstrated significantly different BFS, 54% versus 79% (P = .01). Metastasis-free survival and prostate cancer-specific survival in the VHR group versus HR group were 76% versus 87% (P = .108) and 74% versus 100% (P = .157). Patients reaching nadir PSA <0.1 (n = 80) had significantly better outcomes than the rest (n = 17), with BFS 70% versus 7% (P < .001). Acute grade 2 gastrointestinal tract (GI) and genitourinary tract (GU) toxicity occurred in 27% and 40%, grade 3 GI and GU toxicity in 1% and 3%. Late GI and GU grade 2 toxicity occurred in 1% and 8%. ConclusionsHigh-risk prostate cancer patients obtained favorable 10-year outcomes with low toxicity. There were significantly better results in the HR versus the VHR group, both better than the N+/PSA ≥100 group. A nadir PSA value < 0.1 predicted good prognosis.

Predictors of poor response to first-generation anti-androgens as criteria for alternate treatments for patients with non-metastatic castration-resistant prostate cancer.

There are no criteria for administering first- or second-generation anti-androgens (FGA and SGA, respectively) to patients with non-metastatic castration-resistant prostate cancer (nmCRPC). This study aimed to assess the efficacy of alternative FGA therapy in nmCRPC patients and the prognosis of these patients and to identify factors for predicting patients potentially responsive to FGA. Data from 63 men with nmCRPC who underwent alternative FGA therapy (bicalutamide, flutamide, or chlormadinone acetate) as first-line therapy after failure of primary androgen-deprivation therapy (PADT) between 2004 and 2017 at Hiroshima University Hospital and affiliated hospitals were retrospectively investigated. The associations of clinicopathological parameters with overall survival (OS) and prostate-specific antigen (PSA) progression-free survival (PFS) of alternative FGA-treated patients were analyzed. Time to CRPC [p = 0.007, hazard ratio (HR) = 4.77], regional lymph node involvement at the diagnosis of CRPC (p = 0.022, HR = 2.42), and PSA-PFS of alternative FGA therapy ≤ 6months (p = 0.020, HR = 2.39) were identified as prognostic factors using a multivariate analysis. Additionally, Cox proportional hazard models revealed that PSA nadir value > 1ng/mL during PADT (p = 0.034, HR = 2.40) and time from starting PADT to PSA nadir ≤ 1year (p = 0.047, HR = 1.85) were predictive factors for worse PSA-PFS in alternative FGA therapy. Shorter time to CRPC, regional lymph node involvement, PSA nadir during PADT > 1ng/mL, and time from starting PADT to PSA nadir ≤ 1year might suggest the potential benefit of immediate commencement of SGA, compared to FGA administration after nmCRPC diagnosis.

Docetaxel Versus Surveillance After Radical Radiotherapy for Intermediate- or High-risk Prostate Cancer—Results from the Prospective, Randomised, Open-label Phase III SPCG-13 Trial

BackgroundDocetaxel combined with androgen deprivation therapy (ADT) has improved patient survival for advanced prostate cancer (PCa). ObjectiveThis randomised trial aimed to evaluate whether six courses of docetaxel improved biochemical disease–free survival (BDFS) after radical radiotherapy (RT) for intermediate- or high-risk PCa patients. Design, setting, and participantsA total of 376 patients were randomised in this multinational phase III study, and received either six cycles of adjuvant docetaxel 75 mg/m2 every 3 wk without continuous prednisone (arm A, n = 188) or surveillance (arm B, n = 188) after RT (NTC006653848). Neoadjuvant/adjuvant ADT was mandatory for all the patients. The primary endpoint was rising prostate-specific antigen (PSA) ≥2 ng/ml above the nadir PSA value. Intermediate- or high-risk PCa was defined as T2 with a Gleason score (GS) of 4 + 3, PSA > 10; T2, GS 8–10, ≤ 70 ng/ml; or any T3. The patients were followed for 5 yr by assessing PSA levels every 3 mo for 2 yr and every 6 mo thereafter. Outcome measurements and statistical analysisThe study power was 89% to detect a difference in BDFS between groups, and the sample size calculation accounted for the T2/T3 distribution, where a 12%/15% difference in BDFS was assumed for the T2/T3 patients. Results and limitationsAll six cycles were completed in 147 (78%) of the patients in arm A. The median age was 67 yr in both treatment groups, 75% had T3 disease, and 47% had GS 8–10. The median follow-up was 59 mo (range 1–111 mo). The primary endpoint was observed for 58 patients in arm A (docetaxel) and for 57 patients in arm B (surveillance). The Kaplan-Meier analysis showed no difference in the BDFS curves (p = 0.6) between the treatment groups. The 5-yr estimated biochemical progression rates were 31% for arm A and 28% for arm B. Febrile neutropenia occurred in 16% of the docetaxel patients. No deaths were related to the docetaxel treatment. There were 43 deaths during the trial, including 20 in arm A and 23 in arm B, of which nine and seven, respectively, were due to PCa. The hazard ratio from Cox multivariate analysis for PSA progression of arm A (docetaxel) versus arm B (surveillance) was 1.14 (95% confidence interval 0.79–1.64, p = 0.5). ConclusionsAdjuvant docetaxel without prednisone did not improve BDFS after radical RT with ADT for intermediate- or high-risk PCa. Patient summaryWe compared six cycles of adjuvant docetaxel given after radical external radiotherapy plus androgen deprivation therapy to surveillance in intermediate- and high-risk localised prostate cancer. We found no overall benefit in this setting.

Experience with using fosfestrol for treating metastatic castrate-resistant prostate cancer in resource-limited setting

Abstract Background: Fosfestrol is a low-cost estrogen analog that is useful in the management of metastatic prostate cancer in resource-challenged settings. It acts by altering the pituitary axis, adrenal secretion, and 5-alpha reductase activity. Patients and Methods: The outcomes of metastatic castration-resistant prostate cancer patients treated with fosfestrol in our center between June 2012 and December 2015 were analyzed retrospectively. Fosfestrol was given orally at a dose of 120 mg thrice daily. Event was defined as the discontinuation of fosfestrol due to tumor progression or drug toxicity or death due to any cause. The event-free survival (EFS) and overall survival (OS) were calculated by the Kaplan–Meier method. Results: The analysis included 47 patients with a median age of 65 years. Initial Gleason score was available for 41 of 47 patients, of which 17% (7), 39% (16), and 44% (18) were low risk, intermediate risk, and high risk, respectively. The most common site of metastasis was bone (98%). Of 47 patients, 32 (68%) received fosfestrol as the second line of treatment after progression on complete androgen blockade, 14/47 (30%) received it as the third line, and 1/47 received it as the fourth line of treatment. The median prostate-specific antigen (PSA) value at the start of fosfestrol and the nadir PSA value were 43.7 ng/ml and 13.1 ng/ml, respectively. Ninety-one percent (n = 43) of patients had not been previously treated with chemotherapy (docetaxel). Response of PSA of &gt;50% was observed in 55% (n = 26) of patients. The median EFS and median OS after the start of fosfestrol were 6.8 and 14.7 months, respectively, with a median follow-up of 10.9 months. Only two patients developed Grade 3 toxicity, both of whom had diarrhea. Conclusions: In resource-challenged settings, oral fosfestrol is an effective, cheap, and safe option for the management of metastatic prostate cancer progressing after first-line complete androgen blockade.

Does seminal vesicle-sparing robotic radical prostatectomy influence postoperative prostate-specific antigen measured with an ultrasensitive immunoassay?

PURPOSE Sparing of the seminal vesicles during robotic radical prostatectomy (SVRP) is an attempt to reduce potential damage to the hypogastric pelvic nerves. However, the seminal vesicles are known to express prostate-specific antigen (PSA) and it is unknown whether SVRP influences oncological outcome measured with ultrasensitive PSA immunoassays. In a retrospective study we analysed whether SVRP affects oncological outcome in terms of ultrasensitive PSA nadir and biochemical recurrence as compared with standard robotic assisted laparoscopic radical prostatectomy (sRALP). METHODS Overall, 102 patients underwent robotic prostatectomy. Patients were non-randomly allocated to the following surgical techniques: a SVRP group of 39 patients who underwent robotic radical prostatectomy sparing the tips of the seminal vesicles; a standard group of 63 patients who were treated with sRALP. Inclusion criteria were histologically proven negative margins (R0) and negative lymph node status (pN0). PSA was measured with an ultrasensitive assay. The Mann-Whitney U-test was used to compare the differences in PSA nadir and follow-up PSA. Biochemical recurrence was diagnosed if PSA rose to ≥0.2 mg/ml. RESULTS Median (range) follow-up was 31.4 (16.4–43.8) months. Preoperative PSA was 5.8 (0.13–15.29) ng/ml in the SVRP group and 7.1 (0.8–46) ng/ml in the sRALP group. Two cases of biochemical recurrence occurred in the sRALP group during follow-up. One of these two patients presented with locally advanced prostate carcinoma diagnosed from the definitive pathological specimen (pT3b). No patient of the SVRP group had seminal vesicle invasion or biochemical recurrence. No significant between-group difference in terms of PSA nadir and follow-up PSA was recorded. However, the percentage of patients who did not reach PSA nadir values of <0.01 ng/ml was higher in the SVRP group (10 vs 5% in the sRALP group). CONCLUSIONS Compared with sRALP, SVRP had no clinical impact on oncological outcome in terms of PSA nadir or biochemical recurrence measured with an ultrasensitive PSA immunoassay. A slightly higher PSA nadir after SVRP seems to be expected, which needs to be mentioned during follow-up of these patients.

Salvage High-Dose Rate (HDR) Brachytherapy as a Treatment for Locally Recurrent Prostate Cancer after Primary Radiation Therapy

Salvage brachytherapy is a treatment option for patients with locally recurrent prostate cancer following definitive radiotherapy. We report the tumor control and toxicity outcomes from using high-dose rate (HDR) brachytherapy (BT) alone for local salvage. Between 2013 and 2017, thirty-two patients with biopsy-proven (n = 23) or radiologically-evident (n = 9) locally recurrent prostate cancer were treated with salvage HDR brachytherapy. Dose-fractionation schedules included: 19Gy single fraction (n = 24), 15Gy single fraction (n = 5), 26Gy in two fractions (n = 2) and 31.5Gy in three fractions (n = 1). Three patients received treatment to the whole gland; the remaining 29 received focal therapy mapped according to combined pelvic magnetic resonance (MR) imaging and template biopsy findings (n = 21) or MR imaging alone (n = 8). The median time from completion of primary treatment to salvage HDR BT was 57 months. Seventeen patients received androgen deprivation therapy (ADT) as part of their primary treatment. In all cases, ADT had been discontinued prior to salvage HDR BT and was not re-commenced following the procedure. Biochemical progression-free survival (bPFS) using the Kaplan-Meier method was defined according to the Phoenix standard of nadir prostate-specific antigen (PSA) plus ≥2mg/ml. Acute and late genitourinary (GU) and gastrointestinal (GI) toxicities were evaluated using the Common Terminology Criteria for Adverse Events, version 4.0. Late toxicity was defined as that occurring ≥90 days after completion of salvage brachytherapy. Median follow-up after salvage HDR brachytherapy was 24 months. Median PSA nadir value was 0.8 reached at a median of 5 months from day of implant. The 2-year biochemical progression-free survival rate was 60.0%. The 2-year local relapse rate was 9.3% with 8 out of the 11 recurrences occurring at distant sites. Acute and late GU and GI toxicities are shown in Table 1. Two patients developed late grade 3 urinary toxicity, both urethral strictures requiring surgical correction. No late GI complications of grade 2 or higher were encountered with no reports of rectal fistulae or requirement for defunctioning colostomy.Abstract SU_28_2277; Table 1Number of patients presenting with acute (<90 days) and late (≥90 days) genitourinary and gastrointestinal toxicities following salvage high-dose rate brachytherapyToxicityACUTELATEGenitourinarynnGrade 1/22219Grade 302Grade 400GastrointestinalGrade 1/241Grade 300Grade 400 Open table in a new tab High-dose rate brachytherapy is an effective modality for the salvage treatment of locally recurrent prostate cancer with very good local control rates and an acceptable long-term toxicity profile. The high rate of distant relapse underscores the current challenge of accurate staging of systemic disease and appropriate patient selection in the salvage setting. The use of more sensitive imaging modalities such as PSMA-PET may improve this in the future.

MP05-04 EFFECTIVENESS OF COMBINATION THERAPY OF EXTERNAL-BEAM RADIATION AND HIGH DOSE-RATE BRACHYTHERAPY FOR HIGH-RISK PROSTATE CARCINOMA

You have accessJournal of UrologyProstate Cancer: Localized: Radiation Therapy I1 Apr 2017MP05-04 EFFECTIVENESS OF COMBINATION THERAPY OF EXTERNAL-BEAM RADIATION AND HIGH DOSE-RATE BRACHYTHERAPY FOR HIGH-RISK PROSTATE CARCINOMA Kenjiro Suzuki, Suguru Shirotake, Koshiro Nishimoto, Soichi Makino, Hideyuki Kondo, Takashi Okabe, Yota Yasumizu, Kiichiro Kodaira, Shingo Kato, and Masafumi Oyama Kenjiro SuzukiKenjiro Suzuki More articles by this author , Suguru ShirotakeSuguru Shirotake More articles by this author , Koshiro NishimotoKoshiro Nishimoto More articles by this author , Soichi MakinoSoichi Makino More articles by this author , Hideyuki KondoHideyuki Kondo More articles by this author , Takashi OkabeTakashi Okabe More articles by this author , Yota YasumizuYota Yasumizu More articles by this author , Kiichiro KodairaKiichiro Kodaira More articles by this author , Shingo KatoShingo Kato More articles by this author , and Masafumi OyamaMasafumi Oyama More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.163AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Our institution is a high volume center of radiotherapy for prostate cancer patients (PCaPts). We have performed either neoadjuvant androgen deprivation therapy (NADT), followed by external-beam radiation therapy (total 39 Gray) and high dose-rate brachytherapy (HDR-B, total 18 Gray) (NEH) or radical prostatectomy (RP) on high-risk PCaPts, as defined by prostate specific antigen (PSA) level (>20ng/mL), pathology of biopsy specimen (Gleason score [GS]: ≥8), and/or clinical staging (≥T3). No comparative studies have been reported for NEH and RP. In order to determine if NEH is a better therapy than RP, we compared biochemical recurrence-free survival (bRFS, i.e., post therapeutic PSA elevation) and overall survival (OS) between NEH and RP on high-risk PCaPts. METHODS Between 2007 and 2012, 192 and 167 high-risk PCaPts were treated by NEH and RP, respectively. Biochemical failure (BF) for NEH was defined using Phoenix definition: any PSA increase of >2 ng/mL higher than the PSA nadir value, regardless of the PSA nadir value. Whereas BF for RP was defined as PSA values of >0.2 ng/mL. Of note, PSA of 18 RP-cases (10.8 %) did not decrease to less than 0.2 ng/mL. In these cases, the day of PSA nadir was defined as BF date. Difference between bRFS and OS were calculated using Kaplan-Meier method and log-rank tests. RESULTS The median follow-up duration was 58.7 months. Age was significantly older in NEH group (median [interquartile range] = 71.9 [67.3-75.3] years) than in RP group (69.0 [64.9-72.3] years, p< 0.001, Mann-Whitney U test [MWU]). Initial PSA was higher in NEH (20.0 [10.1-43.6]) than RP group (15.9 [8.1-24.7] ng/dL, p<0.01, MWU). RP group had a trend of higher GS (72.1%) than NEH group (62.5%, p=0.07, chi square test). T stage was similar (NEH [66.1 %] vs RP [66.4 %], p=0.928, chi square test). The 5- and 7-year bRFS rates in NEH group (0.79 and 0.76, respectively) were significantly higher than those in RP group (0.51 and 0.41, respectively, p<0.001 each, Fig. 1A). However, in OS, no significant difference was found (p=0.838). CONCLUSIONS We retrospectively compared clinical outcomes of NEH and RP, and found that NEH might be as effective as RP for high-risk PCaPts. Currently, we are preparing prospective randomized case study comparing NEH and RP by adjusting age, GS, PSA, and T stage. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e38-e39 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Kenjiro Suzuki More articles by this author Suguru Shirotake More articles by this author Koshiro Nishimoto More articles by this author Soichi Makino More articles by this author Hideyuki Kondo More articles by this author Takashi Okabe More articles by this author Yota Yasumizu More articles by this author Kiichiro Kodaira More articles by this author Shingo Kato More articles by this author Masafumi Oyama More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

A comparison of surrogate endpoints for all cause mortality in men with localized unfavorable-risk prostate cancer.

21 Background: Several surrogates for prostate cancer-specific mortality exist, but whether these are surrogates for all cause mortality (ACM), and how their performance compares, is unknown. We investigated the relative efficacy of 4 candidate surrogates for ACM using the proportion of treatment effect (PTE) metric. Methods: Two-hundred and six men with localized unfavorable-risk prostate cancer were randomized to radiation therapy (RT) or RT and 6 months of androgen-deprivation therapy (ADT) from 1995 to 2001 and followed for a median of 16.62 years. Among the 159 men with no or minimal comorbidity, a significant reduction in the risk of death was observed in those randomized to RT and ADT versus RT alone; these 159 men formed the study cohort. In order to assess whether the candidate surrogated satisfied Prentice’s criteria for surrogacy, Cox regression analyses were performed to assess the risk of death for each of the candidate surrogates and treatment before and after adjusting for prostate-specific antigen (PSA), age at randomization, T category, and Gleason score. Results: PSA nadir &gt; 0.5 ng/mL, PSA doubling time &lt; 9 months and interval to PSA failure &lt; 30 months met Prentice’s criteria for surrogacy (P = 0.01, 0.003, and 0.03 for the surrogate covariate in the multivariable model, respectively) for ACM, while PSA failure did not (P = 0.10). For the three surrogates, the PTE values were 103.86%, 43.09%, and 41.26%, respectively. Conclusions: A PSA nadir value of &gt; 0.5 ng/mL following RT and ADT identified men prior to PSA failure who were at high-risk for death and therefore could be used to select men for entry, at the time of PSA nadir and before PSA failure, onto randomized trials evaluating the impact on survival of salvage ADT with or without agents shown to prolong survival in men with castrate-resistant metastatic prostate cancer. By enriching study cohorts with men who have achieved a surrogate endpoint for ACM, one can enhance the likelihood that the study will be able to observe whether survival is prolonged when novel treatment is added to ADT, as compared to ADT alone, in an abbreviated time period. Clinical Trial Number: NCT00116220