Neoadjuvant hormonal therapy for patients with low risk prostate cancer stimulates lymphvessel invasion and shorten biochemical recurrence-free survival periods

2017 ◽  
Vol 16 (3) ◽  
pp. e1326-e1327
Author(s):  
Y. Miyata ◽  
Y. Mochizuki ◽  
Y. Shida ◽  
T. Matsuo ◽  
T. Hakariya ◽  
...  
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.


2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 201-201
Author(s):  
Ryuta Tanimoto ◽  
Kensuke Bekku ◽  
Shin Ebara ◽  
Motoo Araki ◽  
Hiroyuki Yanai ◽  
...  

201 Background: To determine whether neoadjuvant hormonal therapy improves the biochemical outcome for men with low or intermediate risk prostate cancer and undergoing permanent brachytherapy. Methods: From January 2004 to April 2011, 449 patients with low-risk (221 men) or intermediate-risk (228 men) based on NCCN guideline underwent transperineal ultrasonography-guided permanent 125I-seed brachytherapy. Of these patients, 186 received neoadjuvant hormonal therapy (NHT). The median patient age was 67 years. The median follow-up (SD) was 48 (20) months (calculated from the day of implantation). Biochemical disease-free (BDF) survival was defined using Phoenix definition. The clinical variables evaluated for BDF survival included presence of NHT, Gleason score, clinical T-stage and pretreatment PSA. Results: For all patients, the 1, 3, 5-year actuarial BDF survival rates were 99.2%, 96.2% and 90% without NHT, 100%, 97.2%, 91.0% with NHT (p=0.954). When stratified by risk group, NHT did not improve the outcome for patients at low risk (P = 0.745) or at intermediate risk (P = 0.888). The duration (<= 5 vs >5 months) or combinations (single vs combined androgen blockade) of hormonal therapy were not statistically significant in predicting biochemical recurrence. In a multivariate analysis (shown below), only the Gleason score was a strong predicting factor, while NHT as well as pretreatment PSA, T stage were insignificant. Conclusions: In patients treated by permanent prostate brachytherapy, NHT did not improve the biochemical outcome for those at low-risk or intermediate-risk features. Furthermore, the duration or combinations of hormonal therapy conferred no additional biochemical advantage. [Table: see text]


2011 ◽  
Vol 11 (1) ◽  
pp. 16-22 ◽  
Author(s):  
Eliahu Gez ◽  
Joshua Genesin ◽  
Daniel Shahar ◽  
Valeriya Semenisty ◽  
Tanya Mashiac ◽  
...  

AbstractBackground: In low-risk prostate cancer, the target volume for radiotherapy is the prostate gland only and prostate brachytherapy with an I-125 implant provides the most conformal radiotherapy.Methods: Patients underwent a pre-implant prostate volume study from which a treatment plan was developed 2 weeks prior to implant. A dosimetric study was performed 1 month following the implant. The prescription dose was 145 Gy with the 95% isodose line covering the entire target volume. The maximal dose to the urethra was less than 210 Gy. Follow-up included serum PSA and IPSS evaluation every 3 months during the first year and then every 6 months beginning in the second year.Results: During December 2000–March 2009, 181 patients with early prostate cancer underwent I-125 implant. The median post-implant PSA value of the entire cohort was 0.7 ng/ml. No patient developed clinical failure. In the follow-up, nine patients had biochemical failure according to the RTOG-ASTRO Phoenix definition (Nadir + 2.0 ng/ml). Of these, one patient refused hormonal therapy desiring to preserve sexual potency, and eight patients received hormonal therapy with a decreased serum PSA to 0.0 ng/ml. The treatment side effects were primarily urinary disturbances.Conclusion: An I-125 implant is an effective and well-tolerated treatment and should be recommended for patients with low-risk prostate cancer.


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