NRG Oncology RTOG 0415: A randomized phase III non-inferiority study comparing two fractionation schedules in patients with low-risk prostate cancer.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 1-1 ◽  
Author(s):  
W. Robert Lee ◽  
James J. Dignam ◽  
Mahul Amin ◽  
Deborah Bruner ◽  
Daniel Low ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Biochemical Recurrence ◽  
Disease Free Survival ◽  
Low Risk ◽  
Free Survival ◽  
Risk Prostate Cancer ◽  
Low Risk Prostate Cancer ◽  
Grade 3 ◽  
Disease Free

1 Background: To determine whether the efficacy of a hypofractionated (H) schedule is no worse than a conventional (C) schedule in men with low-risk prostate cancer. Methods: From April 2006 to December 2009, one thousand one hundred fifteen men with low-risk prostate cancer (clinical stage T1-2a, Gleason ≤ 6, PSA < 10) were randomly assigned 1:1 to a conventional (C) schedule (73.8 Gy in 41 fractions over 8.2 weeks) or to a hypofractionated (H) schedule (70 Gy in 28 fractions over 5.6 weeks). The trial was designed to establish with 90% power and alpha = 0.05 that (H) results in 5-year disease-free survival (DFS) that is not lower than (C) by more than 7% (hazard ratio (HR) < 1.52). Secondary endpoints include freedom from biochemical recurrence (FFBR) and overall survival. At the third planned interim analysis (July 2015), the NRG Oncology Data Monitoring Committee recommended that the results of the trial be reported. Results: One thousand one hundred and one protocol eligible men were randomized: 547 to C and 554 to H. Median follow-up is 5.9 years. Baseline characteristics are not different according to treatment arm. At the time of analysis 185 DFS events have been observed; 99 in the C arm and 86 in the H arm. The estimated 7-year disease-free survival is 75.6% (95% CI 70.3, 80.1) in the C arm and 81.8% (77.5, 85.3) in the H arm. The DFS HR (C/H) is 0.85 (0.64, 1.14). Comparison of biochemical recurrence (HR = 0.77, (0.51, 1.17)) and overall survival (HR = 0.95, (0.65, 1.41)) also met protocol non-inferiority criteria. Grade ≥ 3 GI toxicity is 3.0% (C) vs. 4.6% (H), Relative risk (RR) for H vs. C 1.53, (95% CI 0.86, 2.83); grade ≥ 3 GU toxicity is 4.5% (C) vs. 6.4% (H), RR = 1.43 (0.86,2.37). Conclusions: In men with low-risk prostate cancer, 70 Gy in 28 fractions over 5.6 weeks is non-inferior to 73.8 Gy in 41 fractions over 8.2 weeks. Clinical trial information: NCT00331773.

Adjuvant docetaxel after definitive radiotherapy for high-risk prostate cancer: A meta-analysis of randomized clinical trials.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 374-374
Author(s):  
Ray Manneh Kopp ◽  
Mauricio Lema ◽  
Linda Ibatá
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
High Risk ◽  
Meta Analysis ◽  
Disease Free Survival ◽  
Standard Of Care ◽  
Free Survival ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer ◽  
Disease Free

374 Background: In order to improve long term results for high-risk prostate cancer, several clinical trials have tested the addition of docetaxel chemotherapy. The outcomes of this trials have not led to clear conclusions. We conducted a meta-analysis of randomized phase 3 trials testing the efficacy of docetaxel after radiotherapy in high risk prostate cancer patients. Methods: A systematic review of PubMed (Medline), Embase and the Cochrane Library was conducted. We followed the PRISMA guidelines, three investigators independently selected the articles and verified inclusion criteria. We compared the overall survival and disease-free survival between the intervention group (adjuvant chemotherapy with docetaxel) and the control group (without adjuvant chemotherapy) by calculating the hazard ratio (HR) with 95% confidence intervals (CIs). Pooled effects were calculated using random-effects or fixed-effects models based on the heterogeneity of included studies. Results: 382 publications were identified, four phase III trials (STAMPEDE, RTOG0521, SPCG-13, GETUG 12) comparing docetaxel vs standard of care after radiotherapy for high-risk prostate cancer fulfilled the inclusion criteria with data from 2034 patients (1135 in placebo group and 899 in adjuvant docetaxel group). Heterogeneity was not found between the included studies for OS (I 2 0%), but it was found between studies for disease-free survival (I2 60%). Adjuvant docetaxel chemotherapy showed overall survival benefit when compared to ADT alone (HR 0,72 95% CI 0,54-0,96). Adjuvant docetaxel also improved the disease-free survival when compared to ADT alone (HR 0,74 95% CI 0,64-0,86). No evidence of publication bias was observed. Conclusions: This meta-analysis shows that docetaxel after definitive radiotherapy in high-risk prostate cancer is likely to be more effective than standard of care in terms of overall survival and disease-free survival. Further prospective studies are needed in order to increase the sample that would lead to show a more robust data.

scholarly journals Stereotactic body radiotherapy for low-risk prostate cancer: Five-year outcomes.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 94-94
Author(s):  
D. Freeman ◽  
C. R. King
Keyword(s):  
Prostate Cancer ◽  
Stereotactic Body Radiotherapy ◽  
Progression Free Survival ◽  
Low Risk ◽  
Free Survival ◽  
Risk Prostate Cancer ◽  
Low Risk Prostate Cancer ◽  
Biochemical Progression ◽  
Grade 3

94 Background: Hypofractionated, stereotactic body radiotherapy (SBRT) is an emerging treatment approach for prostate cancer. We present the outcomes for low-risk prostate cancer patients with a median follow-up of 5 years after SBRT. Methods: Between Dec. 2003 and Dec. 2005, a pooled cohort of 41 consecutive patients from Stanford, CA and Naples, FL received SBRT with CyberKnife for clinically localized, low-risk prostate cancer. Prescribed dose was 35–36.25 Gy in five fractions. No patient received hormone therapy. Kaplan-Meier biochemical progression-free survival (defined using the Phoenix method) and RTOG toxicity outcomes were assessed. Results: At a median follow-up of 5 years the biochemical progression-free survival was 93% (95% CI = 84.7% to 100%). Acute side effects resolved within 1–3 months of treatment completion. There were no grade 4 toxicities. No late grade 3 rectal toxicity and only one late grade 3 genitourinary toxicity occurred following repeated urologic instrumentation. Conclusions: Five-year results of SBRT for localized prostate cancer demonstrate the effectiveness and safety of shorter courses of high dose per fraction radiation delivered with SBRT technique. Ongoing clinical trials are expected to further support this experience. [Table: see text]

scholarly journals Effect of Chemotherapy With Docetaxel With Androgen Suppression and Radiotherapy for Localized High-Risk Prostate Cancer: The Randomized Phase III NRG Oncology RTOG 0521 Trial

2019 ◽  
Vol 37 (14) ◽  
pp. 1159-1168 ◽  
Author(s):  
Seth A. Rosenthal ◽  
Chen Hu ◽  
Oliver Sartor ◽  
Leonard G. Gomella ◽  
Mahul B. Amin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Distant Metastasis ◽  
Disease Free Survival ◽  
Free Survival ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer ◽  
Androgen Suppression ◽  
Disease Free

PURPOSE Radiotherapy (RT) plus long-term androgen suppression (AS) are a standard treatment option for patients with high-risk localized prostate cancer. We hypothesized that docetaxel chemotherapy (CT) could improve overall survival (OS) and clinical outcomes among patients with high-risk prostate cancer. PATIENTS AND METHODS The multicenter randomized NRG Oncology RTOG 0521 study enrolled patients with high-risk nonmetastatic disease between 2005 and 2009. Patients were randomly assigned to receive standard long-term AS plus RT with or without adjuvant CT. RESULTS A total of 612 patients were enrolled; 563 were evaluable. Median prostate-specific antigen was 15.1 ng/mL; 53% had a Gleason score 9 to 10 cancer; 27% had cT3 to cT4 disease. Median follow-up was 5.7 years. Treatment was well tolerated in both arms. Four-year OS rate was 89% (95% CI, 84% to 92%) for AS + RT and 93% (95% CI, 90% to 96%) for AS + RT + CT (hazard ratio [HR], 0.69; 90% CI, 0.49 to 0.97; one-sided P = .034). There were 59 deaths in the AS + RT arm and 43 in the AS + RT + CT arm, with fewer deaths resulting from prostate cancer in the AS + RT + CT arm versus AS + RT (23 v 16 deaths, respectively). Six-year rate of distant metastasis was 14% for AS + RT and 9.1% for AS + RT + CT, (HR, 0.60; 95% CI, 0.37 to 0.99; two-sided P = .044). Six-year disease-free survival rate was 55% for AS + RT and 65% for AS + RT + CT (HR, 0.76; 95% CI, 0.58 to 0.99; two-sided P = .043). CONCLUSION For patients with high-risk nonmetastatic prostate cancer, CT with docetaxel improved OS from 89% to 93% at 4 years, with improved disease-free survival and reduction in the rate of distant metastasis. The trial suggests that docetaxel CT may be an option to be discussed with selected men with high-risk prostate cancer.

125I Brachytherapy for Localized Prostate Cancer: A Single Institution Experience

2013 ◽  
Vol 99 (1) ◽  
pp. 83-87 ◽  
Author(s):  
Alessia Guarneri ◽  
Angela Botticella ◽  
Andrea Riccardo Filippi ◽  
Fernando Munoz ◽  
Giancarlo Beltramo ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Multivariate Analysis ◽  
Early Stage ◽  
Disease Free Survival ◽  
Localized Prostate Cancer ◽  
Free Survival ◽  
Genitourinary Toxicity ◽  
Grade 3 ◽  
Disease Free

Aims and background To evaluate the clinical outcome of a cohort of localized prostate cancer patients treated with 125I permanent brachytherapy at the University of Turin. Methods and study design A retrospective analysis was carried out on 167 consecutive patients with early stage prostate adenocarcinoma who underwent 125I brachytherapy between January 2003 and December 2010. A minimum follow-up of ≥12 months was mandatory for inclusion. Biochemical disease-free survival (defined on the basis of the ASTRO definition and the ASTRO-Phoenix definition) was chosen as the primary end point. Secondary end points were gastrointestinal and genitourinary toxicity (acute and late, defined according to the RTOG scale). Results With a median follow-up of 42 months (range, 13.5–90.7), biochemical disease-free survival at 3 and 5 years was respectively 91.1% and 85.7%, according to the ASTRO definition and 94.5% and 85.1% according to ASTRO-Phoenix definition (for statistical purposes, only the ASTRO definition was used). Hormone treatment and nadir PSA (cutoff of 0.35 ng/ml) were the only factors affecting biochemical disease-free survival both on univariate ( P = 0.02 and P = 0.001, respectively) and multivariate analysis (HR 0.024; P = 0.021 and HR 21.6; P = 0.006, respectively). Only 3.6% of patients experienced ≥grade 3 acute urinary toxicity and 5% ≥grade 3 late urinary toxicity. Prior transurethral prostate resection was the only independent predictor of grade 3 late urinary toxicity on multivariate analysis (HR 0.13; P = 0.009). Conclusions This mono-institutional series confirmed that brachytherapy is an effective and safe treatment modality for localized prostate cancer, with acceptable short- and long-term morbidity rates.

scholarly journals A-kinase interacting protein 1, a potential biomarker associated with advanced tumor features and CXCL1/2 in prostate cancer

2020 ◽  
Vol 35 (2) ◽  
pp. 74-81
Author(s):  
Danlan Wang ◽  
Yuanfang Luo ◽  
Yonglian Guo ◽  
Guohao Li ◽  
Fan Li
Keyword(s):  
Prostate Cancer ◽  
Overall Survival ◽  
Disease Free Survival ◽  
High Expression ◽  
Interacting Protein ◽  
Free Survival ◽  
T Stage ◽  
Potential Biomarker ◽  
Disease Free ◽  
Cxcl1 Expression

Objective: This study aimed to investigate the correlation of A-kinase interacting protein 1 (AKIP1) with chemokine (C-X-C motif) ligand 1 (CXCL1) and CXCL2, as well as their associations with clinical characteristics and prognosis in prostate cancer patients. Methods: A total of 248 eligible prostate cancer patients who underwent surgery were consecutively recruited, and tumor tissues were collected during the surgery. AKIP1, CXCL1, and CXCL2 expression in tumor tissues were assessed by immunohistochemistry. Disease-free survival and overall survival were recorded, and the median follow-up time was 27 months. Results: The proportion of patients with AKIP1, CXCL1, and CXCL2 high expression was 56.5%, 63.7%, and 56.9%, respectively. Additionally, AKIP1 expression positively correlated with CXCL1 expression ( P<0.001) and CXCL2 expression ( P<0.001), and CXCL1 expression was positively associated with CXCL2 expression ( P<0.001). Furthermore, AKIP1 expression positively correlated with pathological T stage ( P<0.001) and pathological N stage ( P=0.003). CXCL1 expression was positively associated with pathological T stage ( P<0.001) and pathological N stage ( P<0.001) as well. However, the CXCL2 expression only positively correlated with pathological T stage ( P=0.002). Also, AKIP1 high expression correlated with worse disease-free survival ( P=0.049) and OS ( P=0.013), and CXCL1 high expression was associated with unfavorable disease-free survival ( P=0.023) but not overall survival ( P=0.052). CXCL2 expression was not correlated with disease-free survival ( P=0.083) or overall survival ( P=0.065). Multivariate Cox’s regression disclosed that AKIP1 high expression independently predicted worse overall survival ( P=0.009). Conclusion: AKIP1 positively associates with CXCL1/2 and is a potential biomarker for disease monitoring as well as prognosis in prostate cancer.

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