A Pretreatment PSA Level of 7 to 10 Ng/mL is an Independent Predictor of Adverse Biochemical Disease Free Survival among Low Risk Prostate Cancer Patients Treated with I-125 Brachytherapy

2008 ◽  
Vol 72 (1) ◽  
pp. S304-S305
Author(s):  
J.A. Cesaretti ◽  
N.N. Stone ◽  
J. Kao ◽  
R.G. Stock
2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 1-1 ◽  
Author(s):  
W. Robert Lee ◽  
James J. Dignam ◽  
Mahul Amin ◽  
Deborah Bruner ◽  
Daniel Low ◽  
...  

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.


2009 ◽  
Vol 181 (4S) ◽  
pp. 756-757
Author(s):  
Alberto Briganti ◽  
Alexander Haese ◽  
Umberto Capitanio ◽  
Andrea Gallina ◽  
Felix K h Chun ◽  
...  

2016 ◽  
Vol 35 (2) ◽  
pp. 189-197 ◽  
Author(s):  
Sami-Ramzi Leyh-Bannurah ◽  
Paolo Dell’Oglio ◽  
Zhe Tian ◽  
Jonas Schiffmann ◽  
Shahrokh F. Shariat ◽  
...  

2018 ◽  
Vol 102 (1) ◽  
pp. 43-50 ◽  
Author(s):  
Matteo Ferro ◽  
Gennaro Musi ◽  
Alessandro Serino ◽  
Gabriele Cozzi ◽  
Francesco Alessandro Mistretta ◽  
...  

2019 ◽  
Vol 37 (14) ◽  
pp. 1159-1168 ◽  
Author(s):  
Seth A. Rosenthal ◽  
Chen Hu ◽  
Oliver Sartor ◽  
Leonard G. Gomella ◽  
Mahul B. Amin ◽  
...  

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.


2017 ◽  
Vol 35 (8) ◽  
pp. 1205-1212 ◽  
Author(s):  
Alexander Kretschmer ◽  
Alexander Buchner ◽  
Markus Grabbert ◽  
Anne Sommer ◽  
Annika Herlemann ◽  
...  

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