scholarly journals Contemporary Radiation Treatment of Prostate Cancer in Africa: A Ghanaian Experience

2018 ◽  
pp. 1-13
Author(s):  
Francis A. Asamoah ◽  
Joel Yarney ◽  
Shivanshu Awasthi ◽  
Verna Vanderpuye ◽  
Puja S. Venkat ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Locally Advanced ◽  
Multivariable Analysis ◽  
Specific Antigen ◽  
Disease Free Survival ◽  
Curative Radiotherapy ◽  
Incidence And Mortality ◽  
High Risk Disease ◽  
Localized Disease

Purpose Data on prostate cancer (PCa) treatment in Africa remains under-reported. We present a review of the management of PCa at the cancer center of the largest tertiary referral facility in Ghana, with emphasis on curative treatment. Methods We retrospectively reviewed data on 1,074 patients seen at the National Center for Radiotherapy and Nuclear Medicine from 2003 to 2016. Patient and disease characteristics at presentation are presented using descriptive statistics. The χ2 and Fisher’s exact tests and Mann-Whitney U test were used to analyze differences between categorical and continuous variables, respectively. Methods of survival analysis were used to evaluate the relative risk of biochemical disease-free survival (bDFS). Results Seventy percent of the study population presented with localized disease. High-risk disease presentation accounted for 64.4% of these patients. Only 57.6% of patients with localized disease received curative radiotherapy. The 5-year overall survival for the curative cohort was 96% (interquartile range, 93% to 98%). The 5-year bDFS rates for low-, intermediate-, and high-risk groups were 95%, 70%, and 48%, respectively. Both Gleason score and pretreatment prostate-specific antigen were significant predictors for bDFS in multivariable analysis. Conclusion We show that the majority of patients with PCa have locally advanced disease at the time of presentation for radiotherapy. bDFS was significantly better for low- and intermediate-risk than for high-risk disease. These data emphasize the dire need to re-evaluate screening and patient education of PCa in regions of the world with high incidence and mortality as well as the need for improved access to care and treatment delivery.

PSA-detected prostate cancer in the United States: A population-based study of 70,345 men with AJCC stage T1cN0M0 disease.

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. 50-50
Author(s):  
Hong Zhang ◽  
Lois B. Travis ◽  
Edward M. Messing ◽  
Ollivier Hyrien ◽  
Rui Chen ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Gleason Score ◽  
Prostate Cancer Screening ◽  
Specific Antigen ◽  
The United States ◽  
Population Based ◽  
Population Based Study ◽  
Ajcc Stage ◽  
High Risk Disease

50 Background: The U.S. Preventive Services Task Force (USPSTF) recently recommended against prostate-specific antigen (PSA)-based screening for prostate cancer. This recommendation has heightened the debate about risks and benefits of prostate cancer screening, and underscored our limited understanding of PSA-detected prostate cancer. The purpose of this study was to determine the frequency of various risks of prostate cancer based on patient characteristics and PSA levels. Methods: This population-based study used the Surveillance, Epidemiology, and End Results (SEER) program to identify men with AJCC stage T1cN0M0 disease diagnosed between 1/2004 and 12/2008. Multivariate logistic regression was conducted to model the probability of developing low (PSA <10 mg/L and Gleason score ≤6), intermediate (PSA between 10 mg/L to 20 mg/L and/or Gleason score 7), and high risk diseases (PSA ≥20 mg/L, and/or Gleason score ≥8). Results: A total of 70,345 men with PSA-detected T1cN0M0 prostate cancer were evaluated. Among them, 47.6%, 35.9% and16.5% had low, intermediate, or high risk disease, respectively. Odds ratios (OR) of having intermediate or high risk disease in patients ≥75 years old were 4.47 (95% confidence interval (CI) 3.81 to 5.26, p<0.01) and 9.39 (95% CI 7.25 to 12.16, p<0.01), respectively, when compared with patients aged <50. Also, black men had increased ORs for intermediate and high risk disease compared with white men (OR 1.50, 95% CI 1.42 to 1.58, p<0.01 for intermediate risk disease; OR 1.84, 95% CI 1.72 to 19.97, p<0.01 for high risk disease). While men aged >75 accounted for 11.8% of the population at risk, they accounted for 24.3% of intermediate and 26.1% of high risk disease. Conclusions: A substantial number of PSA-detected prostate cancer patients have either intermediate or high risk disease at diagnosis. Men age >75 or of black race have the highest risk of presenting with intermediate or high risk disease.

scholarly journals Community Screening of Prostate Cancer in Eastern Nepal

2017 ◽  
Vol 1 (1) ◽  
pp. 53-57
Author(s):  
Narayan Belbase ◽  
C.S. Agrawal
Keyword(s):  
Prostate Cancer ◽  
Positive Predictive Value ◽  
Predictive Value ◽  
Locally Advanced ◽  
Specific Antigen ◽  
Digital Rectal Examination ◽  
Healthy Population ◽  
District Hospitals ◽  
Incidence And Mortality ◽  
Trucut Biopsy

Background: Prostate cancer incurs a substantial incidence and mortality burden, and it ranks among the top ten specific causes of death in males. Objectives: To explore the situation of prostate cancer in a cohort of healthy population in Eastern Nepal. Methods: This study was conducted in the Department of General surgery at B. P. Koirala Institute of Health Sciences, Dharan, Nepal in the department of surgery from July 2010 to June 2011. Males above 50 years visiting Surgical Outpatient Department in BPKIHS were enrolled in the study. Screening camps were organized in four Teaching district hospitals of BPKIHS in Eastern Nepal. Digital rectal examination (DRE) was done by the trained professionals after collecting blood for serum prostatic specific antigen (PSA). Trucut biopsy was done for all individuals with abnormal PSA, DRE or both findings. Results: A total of 1521 males more than 50 years of age were assessed and screened after meeting inclusion criteria. Maximum individuals 1452 (96.2% ) had PSA ≤ 4.0 ng/ml. Abnormal PSA ( > 4 ng/ml) was found in 58 (3.8%) individuals. Abnormal DRE was found in 26 (1.72%) individuals. Both DRE and PSA was abnormal in 26 (1.72%) individuals. On the basis of raised PSA or abnormal DRE 58 (3.84%) individuals were subjected to digitally guided trucut biopsy. Biopsy report revealed Benign Prostatic Hyperplasia in 47 (3.11%) individuals and adenocarcinoma prostate in 11 (0.73%) individuals. The specificity of DRE was 65.95% sensitivity 90.9% and positive predictive value 38.46%. The sensitivity of PSA more than 4ng/ml in detecting carcinoma prostate was 100% and the positive predictive value for serum PSA was 18.96%. Conclusion: The overall cancer detection rate in this study was 0.73% and those detected were locally advanced. Larger community-based studies are highly warranted specially among high-risk groups.

Current clinical presentation and treatment of localized prostate cancer in the United States.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 116-116
Author(s):  
Usama Mahmood ◽  
Lawrence B. Levy ◽  
Paul Linh Nguyen ◽  
Andrew Lee ◽  
Deborah A. Kuban ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Clinical Presentation ◽  
Local Treatment ◽  
Multivariable Analysis ◽  
Sociodemographic Factors ◽  
Low Risk ◽  
Localized Prostate Cancer ◽  
High Risk Disease ◽  
The Us

116 Background: This year, the Surveillance, Epidemiology, and End Results (SEER) database released individual patient clinical Gleason score (GS) at the time of biopsy/transurethral resection of the prostate (TURP), which, along with the previously available clinical stage and prostate-specific antigen (PSA), allows a unique opportunity to study the clinical presentation and treatment selection of prostate cancer in the US. Methods: The SEER database was used to identify men diagnosed with localized prostate cancer in 2010 who were then assigned National Comprehensive Cancer Network (NCCN) risk group based on clinical factors at diagnosis. We determined sociodemographic factors associated with having high-risk disease and analyzed the impact of NCCN risk, along with sociodemographic factors, on local treatment selection. Results: A total of 42,403 men were identified of which 16,171 (38%) had low-risk, 16,990 (40%) had intermediate-risk, and 9,242 (22%) had high-risk disease. Older, non-white, and non-married patients living in counties with higher poverty rates, were most likely to be diagnosed with high-risk disease on multivariable analysis. Of the 38,634 men for whom prostate cancer was the first malignancy, 8,832 (23%) had no local treatment, 15,421 (40%) had prostatectomy, 13,855 (36%) had radiation treatment (including external beam radiation and/or brachytherapy), and 526 (1%) had another form of local tumor destruction (predominantly cryotherapy). In total, 29% of low-risk, 16% of intermediate-risk, and 25% of high-risk patients received no local treatment (p < 0.001). On multivariable analysis, older, non-white, and non-married patients living in counties with higher poverty rates who had low-risk disease, were least likely to receive local treatment. Conclusions: Our analysis provides information regarding the current clinical presentation and treatment of localized prostate cancer in the US. We note persistent disparities in the presentation and treatment of prostate cancer according to sociodemographic factors and potential under treatment of high-risk disease.

Identification of low prostate-specific antigen, high Gleason prostate cancer as a unique hormone-resistant entity with poor survival: A contemporary analysis of 640,000 patients.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5080-5080
Author(s):  
David Dewei Yang ◽  
Brandon Arvin Virgil Mahal ◽  
Christopher Sweeney ◽  
Quoc-Dien Trinh ◽  
Felix Yi-Chung Feng ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Prostate Specific Antigen ◽  
Locally Advanced ◽  
Specific Antigen ◽  
Molecular Classification ◽  
High Grade ◽  
Biological Insight ◽  
Cancer Specific Mortality ◽  
New Treatment

5080 Background: The clinical implications of a low prostate-specific antigen (PSA) in high-grade prostate cancer are unclear. We examined the prognostic and predictive value of a low PSA in high-grade prostate cancer. Methods: We identified 642,975 patients in the National Cancer Database (n = 491,505) and Surveillance, Epidemiology, and End Results program (n = 151,470) with localized or locally advanced prostate cancer from 2004-2013. Patients were stratified by Gleason score (8-10 vs. ≤7) and PSA (≤2.5, 2.6-4.0, 4.1-10.0, 10.1-20.0, and > 20.0 ng/mL) for analyses. Multivariable Fine-Gray competing risks and Cox regressions were used to analyze prostate-cancer specific mortality (PCSM) and all-cause mortality (ACM), respectively. Results: 5.6% of Gleason 8-10 tumors were diagnosed with PSA ≤2.5 ng/mL. Among Gleason 8-10 disease using PSA 4.1-10.0 ng/mL as referent, PCSM was U-shaped with respect to PSA, with adjusted hazard ratio (AHR) of 1.75 (95% CI 1.05-2.92, P = 0.032) for PSA ≤2.5 ng/mL vs. 1.31, 0.88, and 1.60 for PSA 2.6-4.0, 10.1-20.0, and > 20.0 ng/mL. In contrast, PCSM was linear for Gleason ≤7 disease with AHR of 0.32 (95% CI 0.10-1.00, P = 0.050) for PSA ≤2.5 ng/mL vs. 1.13, 1.69, and 3.22 for PSA 2.6-4.0, 10.1-20.0, and > 20.0 ng/mL (PGleason*PSA interaction< 0.001). Gleason 8-10 disease with PSA ≤2.5 ng/mL had a much higher risk of PCSM than standard NCCN high-risk disease (AHR 1.92, 95% CI 1.18-3.14, P = 0.009; 47-month PCSM 14.0% vs. 10.5%). For Gleason 8-10 tumors treated with definitive radiotherapy, androgen deprivation therapy (ADT) was associated with decreased ACM for PSA > 2.5 ng/mL (AHR 0.87, 95% CI 0.81-0.94, P < 0.001) but trended toward increased ACM for PSA ≤2.5ng/mL (AHR 1.27, 95% CI 0.89-1.81, P = 0.194; PADT*PSA interaction= 0.026). Conclusions: Low PSA, high-grade prostate cancer appears to be a unique hormone-resistant entity with a high risk of PCSM that responds poorly to standard treatment. Further molecular classification and trials are urgently needed to develop biological insight into this entity and establish new treatment paradigms, potentially including chemotherapy or novel systemic agents.

Diagnostic characteristics of men harboring lethal prostate cancer: A population-based analysis.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 217-217
Author(s):  
John Thomas Helgstrand ◽  
Nina Klemann ◽  
Birgitte Grønkaer Toft ◽  
Ben Vainer ◽  
Klaus Brasso ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Gleason Score ◽  
Metastatic Disease ◽  
Clinical Characteristics ◽  
Locally Advanced ◽  
Specific Antigen ◽  
Tumor Stage ◽  
Distant Metastatic Disease ◽  
Diagnostic Characteristics ◽  
Localized Disease

217 Background: Prostate specific antigen (PSA) based screening increases the number of men diagnosed with early localized prostate cancer (PCa). Further, curatively intended therapies have been demonstrated to reduce PCa mortality in randomized trials. However, controversy exists, and the overall impact on PCa mortality is less clear. Men who eventually die from PCa may constitute a subgroup with either adverse histopathological characteristics and/or clinically advanced disease at diagnosis. However, the clinical characteristics at diagnosis for men who eventually die from PCa are largely unknown. We retrieved clinical characteristics of all men dying from PCa in Denmark in an 18-year period. Methods: All men who died of PCa during the period 1995 to 2013 were identified in the Danish Causes of Death Registry. Age, Gleason score (GS), tumor stage classification, and PSA were retrieved from the Danish Prostate Cancer Registry (DaPCaR). For validation, manual revision of patient charts was performed. Patients were divided into three clinical phenotypes: distant metastatic disease, locally advanced/N+ disease, and localized disease. Patients with localized disease were further grouped according to GS and PSA. Results: A total of 19,487 men died of PCa in the period 1995-2013. In total, 46.7%, 16.8% and 25.1% of men presented with distant metastatic disease, locally advanced/N+ disease or localized disease, respectively. Among men with localized disease, 85.1% had GS ≥ 7 and only 2.1% (0.5% of all men dying from PCa) only, presented with low risk (PSA < 20 and GS ≤ 6) localized disease at the time of diagnosis. Conclusions: The majority of men (63.5%) who died from PCa had either locally advanced/N+ or M+ disease at diagnosis. Among men with localized PCa at diagnosis, the majority of men subsequently dying from PCa had either PSA > 20 ng/ml and/or adverse histopathological characteristics with Gleason score ≥ 7. A total of 94.5% of patients dying from PCa had either metastatic, locally advanced/N+, and/or GS ≥ 7 disease. Patients with localized disease, PSA < 20 ng/ml and GS ≤ 6 amounted for only 0.5% of all patients dying from PCa.

scholarly journals Aspirin Use and the Risk of Prostate Cancer Mortality in Men Treated With Prostatectomy or Radiotherapy

2012 ◽  
Vol 30 (28) ◽  
pp. 3540-3544 ◽  
Author(s):  
Kevin S. Choe ◽  
Janet E. Cowan ◽  
June M. Chan ◽  
Peter R. Carroll ◽  
Anthony V. D'Amico ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Multivariable Analysis ◽  
Disease Recurrence ◽  
Treatment Modalities ◽  
Risk Category ◽  
Risk Of Death ◽  
High Risk Disease ◽  
Adenocarcinoma Of The Prostate ◽  
Cancer Of The Prostate

Purpose Experimental evidence suggests that anticoagulants (ACs) may inhibit cancer growth and metastasis, but clinical data have been limited. We investigated whether use of ACs was associated with the risk of death from prostate cancer. Patients and Methods This study comprised 5,955 men in the Cancer of the Prostate Strategic Urologic Research Endeavor database with localized adenocarcinoma of the prostate treated with radical prostatectomy (RP) or radiotherapy (RT). Of them, 2,175 (37%) were receiving ACs (warfarin, clopidogrel, enoxaparin, and/or aspirin). The risk of prostate cancer–specific mortality (PCSM) was compared between the AC and non-AC groups. Results After a median follow-up of 70 months, risk of PCSM was significantly lower in the AC group compared with the non-AC group (3% v 8% at 10 years; P < .01). The risks of disease recurrence and bone metastasis were also significantly lower. In a subgroup analysis by clinical risk category, the reduction in PCSM was most prominent in patients with high-risk disease (4% v 19% at 10 years; P < .01). The benefit from AC was present across treatment modalities (RT or RP). Analysis by type of AC medication suggested that the PCSM reduction was primarily associated with aspirin. Multivariable analysis indicated that aspirin use was independently associated with a lower risk of PCSM (adjusted hazard ratio, 0.43; 95% CI, 0.21 to 0.87; P = .02). Conclusion AC therapy, particularly aspirin, was associated with a reduced risk of PCSM in men treated with RT or RP for prostate cancer. The association was most prominent in patients with high-risk disease.

scholarly journals Long-Term Follow-Up of HLA-A2+ Patients with High-Risk, Hormone-Sensitive Prostate Cancer Vaccinated with the Prostate Specific Antigen Peptide Homologue (PSA146-154)

2010 ◽  
Vol 2010 ◽  
pp. 1-11 ◽  
Author(s):  
Supriya Perambakam ◽  
Hui Xie ◽  
Seby Edassery ◽  
David J. Peace
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
High Risk ◽  
Prostate Specific Antigen ◽  
Locally Advanced ◽  
Specific Antigen ◽  
Delayed Type Hypersensitivity ◽  
Cell Immunity ◽  
Hormone Sensitive ◽  
One Year

Twenty-eight HLA-A2+ patients with high-risk, locally advanced or metastatic, hormone-sensitive prostate cancer were immunized with a peptide homologue of prostate-specific antigen, PSA146-154, between July 2002 and September 2004 and monitored for clinical and immune responses. Fifty percent of the patients developed strong PSA146-154-peptide-specific delayed-type hypersensitivity skin responses, tetramer and/or IFN-γ responses within one year. Thirteen patients had stable or declining serum levels of PSA one year post-vaccination. A decreased risk of biochemical progression was observed in patients who developed augmented tetramer responses at six months compared to pre-vaccination levels (P=.02). Thirteen patients have died while 15 patients remain alive with a mean overall survival of 60 months (95% CI, 51 to 68 months) per Kaplan-Meier analysis. A trend towards greater overall survival was detected in men with high-risk, hormone-sensitive CaP who developed specific T-cell immunity following vaccination with PSA146-154 peptide.

Postrandomization analysis assessing survival following radiation therapy (RT) with or without 6 months of androgen suppression therapy (AST) for localized prostate cancer (PCa)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5129-5129
Author(s):  
P. L. Nguyen ◽  
M. H. Chen ◽  
C. J. Beard ◽  
M. Loffredo ◽  
A. A. Renshaw ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prognostic Factors ◽  
High Risk ◽  
Risk Group ◽  
Multivariable Analysis ◽  
Intermediate Risk ◽  
Risk Of Death ◽  
Increased Risk ◽  
High Risk Disease ◽  
Severe Comorbidity

5129 Background: 6 months of AST+RT was shown to improve survival vs. RT alone in men with unfavorable-risk localized PCa, but it is unknown if this benefit applied to all risk subgroups. Methods: Among 206 men with clinical T1b-T2b PCa and at least 1 unfavorable feature (PSA>10 or Gleason >=7 or MRI evidence of T3 disease) randomized to 70Gy of RT with or without 6 months of AST, we performed post-randomization subgroup analyses within four subgroups defined by both risk group (high risk [Gleason 8–10 or PSA >20] or intermediate risk [all others]), and by ACE-27 comorbidity level (no/limited comorbidity or moderate/severe comorbidity). Within the 4 subgroups a log-rank test was used to compare Kaplan Meier estimates of survival (requiring p < 0.05/4 or p < 0.0125 to adjust for multiple comparisons) and within the 2 risk groups we used Cox multivariable analysis (MVA) to assess the association of treatment with the risk of death after adjusting for known prognostic factors. Results: After a median follow-up 8.2 yrs, 74 men died. In men with no or minimal comorbidity, estimates of survival were significantly higher among those who received AST+RT vs. RT alone, regardless of whether they had intermediate risk disease (90.9 vs. 85.8% at 7yrs, p = 0.009) or high-risk disease (88.9% vs. 51.2% at 7yrs, p = 0.007). In men with moderate or severe comorbidity, no difference in survival was observed after AST+RT vs. RT in intermediate risk (p = 0.2) or high risk (p = 0.5). After adjusting for known prognostic factors, treatment with RT as compared to AST+RT was associated with an increased risk of death in men with intermediate (AHR: 3.0 [95% CI: 1.3 to 7.2]; p = 0.01) and high risk disease (AHR: 3.3 [95% CI: 0.94 to 11.3]; p = 0.06) in a model that adjusted for the interaction between treatment and comorbidity. Conclusions: Among men with T1b-T2b prostate cancer who have no or minimal comorbidity, the addition of 6 months of AST to RT was associated with improved survival in men with both intermediate risk and high-risk disease. Among men with moderate to severe comorbidity, neither risk group appeared to benefit from the addition of AST. No significant financial relationships to disclose.

Which patients with localized prostate cancer account for the greatest proportion of prostate cancer deaths?

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 130-130 ◽  
Author(s):  
Michelle Nezolosky ◽  
Paul L. Nguyen ◽  
David Dewei Yang
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Disease Risk ◽  
Risk Group ◽  
Specific Antigen ◽  
Absolute Number ◽  
High Rate ◽  
High Risk Prostate Cancer ◽  
High Risk Disease ◽  
Risk Prostate Cancer

130 Background: We sought to determine which groups of patients, stratified by risk group and age, account for the greatest absolute number of deaths due to prostate cancer. Methods: Using the Surveillance, Epidemiology, and End Results (SEER) database, we identified 437,150 men diagnosed with prostate cancer from 2004 to 2014. Men were excluded if they had N1 or M1 disease, risk group could not be determined, or if prostate cancer was not their first malignancy. Men were categorized as having low (Gleason ≤6, prostate-specific antigen [PSA] < 10 ng/mL, and cT1-T2a), intermediate (Gleason 7, PSA 10-20 ng/mL, or cT2b-T2c), or high risk disease (Gleason 8-10, PSA > 20 ng/mL, or cT3-T4). We calculated the cumulative incidence of prostate cancer-specific mortality (PCSM). Results: Median follow-up was 4.8 years. The overall incidences of diagnosis of low, intermediate, and high risk disease were 29.7% (n = 129,925), 48.0% (n = 209,643), and 22.3% (n = 97,582), respectively. 5-year PCSM for men with low, intermediate, and high risk disease was 0.5%, 1.4%, and 9.4%, respectively, and the 10-year PCSM was 1.6%, 4.0%, and 16.8%. Within 10 years of diagnosis, 6.5% (n = 905) of patients who died of prostate cancer were low risk, 27.4% (n = 3,834) were intermediate risk, and 66.2% (n = 9,278) were high risk. In particular, patients age 70 or older accounted for 49.9% of all high risk prostate cancer diagnoses, but 65.3% of deaths due to high risk prostate cancer. Conclusions: While high risk disease accounted for only 22.3% of the diagnoses, it accounted for 66.2% of the prostate cancer deaths within 10 years of diagnosis. Therefore, high risk patients account for the vast majority of prostate cancer deaths and should remain the focus of the majority of our research efforts. In addition, older patients with high risk disease die of prostate cancer at a disproportionately high rate, which runs counter to the notion that the disease is less of a threat to survival in older men.

PROTEUS: A randomized, double-blind, placebo (PBO)-controlled, phase 3 trial of apalutamide (APA) plus androgen deprivation therapy (ADT) versus PBO plus ADT prior to radical prostatectomy (RP) in patients with localized high-risk or locally advanced prostate cancer (PC).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS5100-TPS5100 ◽  
Author(s):  
Mary-Ellen Taplin ◽  
Martin Gleave ◽  
Christopher P. Evans ◽  
Eleni Efstathiou ◽  
Philip W. Kantoff ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Specific Antigen ◽  
Data Monitoring Committee ◽  
Eligibility Criteria ◽  
Double Blind ◽  
End Points ◽  
Free Survival

TPS5100 Background: Patients (pts) with localized high-risk PC experience disease progression rates of approximately 50% after RP (Kane et al. J Urol. 2007). With the approval of next-generation androgen receptor inhibitors, neoadjuvant studies have shown that 6 months of androgen blockade may improve local disease control at the time of RP (McKay et al. Prostate Cancer Prostatic Dis. 2017; Taplin et al. JCO. 2014). The purpose of this study is to determine if treatment with APA plus ADT before and after RP in pts with localized high-risk or locally advanced PC results in an improvement in pathologic complete response (pCR) rate and metastasis-free survival (MFS) compared with PBO plus ADT. Methods: This international multicenter trial is enrolling pts with localized high-risk or locally advanced PC who are candidates for RP. Eligibility criteria: Any Gleason score (GS) ≥ 4 + 3 with ≥ 6 positive systematic biopsies (SB); any GS ≥ 4 + 3 with ≥ 3 SB and prostate-specific antigen (PSA) ≥ 20 ng/mL; GS ≥ 9 in ≥ 1 SB or targeted biopsies (TB); or ≥ 2 SB or TB with continuous GS ≥ 8, each with ≥ 80% involvement. Stratification: GS (7 or ≥ 8), cN0 or N1, and region (North America, Europe, or rest of world). Randomization: 1:1 to APA (240 mg) plus ADT (LHRHa) or PBO plus ADT. Pts will receive 6 treatment cycles, followed by RP, followed by an additional 6 cycles. Dual primary end points: pCR rate (to be assessed by blinded independent central pathology review) and MFS (to be assessed by blinded independent central radiology review [BICR]). Secondary end points: PSA-free survival and progression-free survival. Imaging with CT or MRI and bone scan will be conducted at baseline and then every 6 months following biochemical failure until documented distant metastasis by BICR, or death. Approximately 1500 pts will be enrolled globally over 3.0 years in 240 sites in 19 countries. An independent data monitoring committee is commissioned to review trial data. Clinical trial information: NCT03767244.

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