scholarly journals Hypofractionated Proton Therapy in Early Prostate Cancer: Results of a Phase I/II Trial at Loma Linda University

2019 ◽  
Vol 6 (1) ◽  
pp. 1-9
Author(s):  
Jason M. Slater ◽  
Jerry D. Slater ◽  
Joseph I. Kang ◽  
Ivan C. Namihas ◽  
B. Rodney Jabola ◽  
...  

Abstract Purpose: To determine whether a hypofractionated proton therapy regimen will control early-stage disease and maintain low rates of side effects similar to results obtained using standard-fraction proton therapy at our institution. Materials and Methods: A cohort of 146 patients with low-risk prostate cancer according to National Comprehensive Cancer Network guidelines (Gleason score <7, prostate-specific antigen [PSA] <10, tumor stage of T1–T2a) received 60 Gy (cobalt Gy equivalent) of proton therapy (20 fractions of 3.0 Gy per fraction) in 4 weeks, a dose biologically equivalent to standard fractionation (44–45 fractions of 1.8 Gy to a total of 79.2 to 81 Gy in 0 weeks). Patients were evaluated at least weekly during treatment, at which time documentation of treatment tolerance and acute reactions was obtained. Follow-up visits were conducted every 3 months for the first 1 years, every 6 months for the next 3 years, then annually. Follow-up visits consisted of history and physical examination, PSA measurements, and evaluation of toxicity. Results: The median follow-up time was 42 months (range, 3–96 months). Acute grade 2 urinary toxicity occurred in 16% (20/120) of the patients; acute grade 2 or higher gastrointestinal toxicity was seen in 1.7% (2/120). At 9 months, 1 patient had late grade 3 urinary toxicity, which resolved by 12 months; no grade 3 gastrointestinal toxicities occurred. The 3-year biochemical survival rate was 99.3% (144/145). The median time to PSA nadir was 30 months. Conclusion: Hypofractionated proton therapy of 60 Gy in 20 fractions was safe and effective for patients with low-risk prostate cancer.

2018 ◽  
Vol 12 (1) ◽  
pp. 54-59
Author(s):  
Ekrem Islamoglu ◽  
Erdem Kisa ◽  
Cem Yucel ◽  
Orcun Celik ◽  
Ozgur Cakmak ◽  
...  

Purpose: We assessed the outcomes of men with low-risk prostate cancer enrolled in active surveillance. Methods: From January 2008, patients in our clinic who were classified as having low-risk prostate cancer according to the D’Amico classification were included in the protocol. Follow-up consisted of regular prostate-specific antigen tests, digital rectal examinations and biopsies. Outcomes were compared between men who progressed and those who did not, and survival analysis was obtained. Results: The mean follow-up period was 46 months. A total of six patients received curative treatment during follow-up as a result of meeting progression criteria. The mean follow-up time from the beginning of active surveillance until curative therapy was 27.1 months. Four of our 64 patients lost their lives due to diseases other than prostate cancer, none of the patients were lost due to prostate cancer. When patients who showed progression and those who did not were compared in terms of positive core numbers and the core tumour percentage we found no significant difference between the two groups ( P>0.05) Conclusion: Active surveillance seems to be a safe and feasible practice in men with low-risk prostate cancer. Gleason score, clinical stage and initial prostate-specific antigen seem to be the most definite criteria for the selection of patients, while it is thought that the number of positive cores is a matter that can be dealt with more flexibility. Level of evidence: Not applicable for this multicentre audit.


2021 ◽  
Vol 93 (4) ◽  
pp. 385-388
Author(s):  
Mohammad Hout ◽  
Ali Merhe ◽  
Nassib Abou Heidar ◽  
Jose M. El-Asmar ◽  
Wassim Wazzan ◽  
...  

Background: The aim of our study was to evaluate the outcome of active surveillance (AS) for prostate cancer for a cohort of patients at our institution. Methods: A total of 43 patients with low risk prostate cancer were enrolled in an active surveillance pilot program at our institution between 2008 and 2018. Follow up protocols included: periodic prostate specific antigen (PSA), digital rectal examination (DRE), multiparametric MRI, and prostate biopsy at one year. Pertinent parameters were collected, and descriptive statistics were reported along with a subset analysis of patients that dropped out of the protocol to receive active treatment for disease progression. Results: Out of 43 eligible patients, 46.5% had a significant rise in follow up PSA. DRE was initially suspicious in 27.9% of patients, and none had any change in DRE on follow up. Initially, prostate MRIs showed PIRADS 3, 4, and 5 in 14%, 37.2%, and 11.6% respectively, while 23.2% had a negative initial MRI. 14% did not have an MRI. Upon follow up, 18.6% of patients had progression on MRI. Initial biopsies revealed that 86% were classified as WHO group 1, while 14% as WHO group 2. With regards to the follow up biopsies, 11.6% were upgraded. 20.9% of our patients had active treatment; 44.4% due to upgraded biopsy results, 22.2% due to PSA progression, 22.2% due to strong patient preference, and 11.1% due to radiologic progression. Conclusions: For selected men with low risk prostate cancer, AS is a reasonable alternative. The decision for active treatment should be tailored upon changes in PSA, DRE, MRI, and biopsy results.


2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 38-38
Author(s):  
Itay Aharon Sternberg ◽  
Changhong Yu ◽  
Gal Elimelech Keren Paz ◽  
Philip H. Kim ◽  
Melanie Bernstein ◽  
...  

38 Background: Due to the inability to predict progression and need for treatment, patients with low-risk prostate cancer (LRPC) managed by active surveillance (AS) are subjected to repeated biopsies and their possible complications. We developed a nomogram predicting the risk of progression in patients on AS for LRPC. Methods: A retrospective review of all patients enrolled in an AS program at Memorial Sloan-Kettering Cancer Center (MSKCC) between 1993 and 2012 was conducted. Demographic, clinical, and pathologic data for patients who met the inclusion criteria for AS (cT1 or cT2a, prostate-specific antigen [PSA] less than 10, Gleason 6 or less, no more than three positive biopsy cores and no greater than 50% involvement of any single core) on the diagnostic and the confirmatory biopsies were collected and used to develop a nomogram for predicting progression-free probability. Multivariable logistic regression analysis was used to model the association between each risk variable (age, PSA levels, clinical stage, biopsy features) and disease progression. Progression was defined as failure to meet the inclusion criteria during follow up. Results: A total of 1,095 patients were enrolled in an AS program at MSKCC during the study period, of which 680 met the inclusion criteria for AS on both the diagnostic and the confirmatory biopsies and had available follow-up. At a median follow-up of 3 years 101 patients progressed. A nomogram predicting the progression-free probability was designed based on characteristics at diagnosis, result of a confirmatory biopsy and the number of negative and positive surveillance biopsies to date. A concordance index of 0.596 was calculated. Conclusions: Conditioned upon external validation, this nomogram can be used to counsel patients on their risk of progression and their surveillance protocol can be adjusted appropriately, possibly avoiding unnecessary biopsies and preventing biopsy-related complications.


2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 94-94
Author(s):  
D. Freeman ◽  
C. R. King

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]


2013 ◽  
Vol 12 (1) ◽  
pp. e583-e584
Author(s):  
F. Mistretta ◽  
A. Losa ◽  
G. Cardone ◽  
M. Lazzeri ◽  
G.M. Gadda ◽  
...  

2019 ◽  
Vol 201 (Supplement 4) ◽  
Author(s):  
Srinath Kotamarti* ◽  
Andrew Wood ◽  
Alyssa Yee ◽  
Daniel Rabinowitz ◽  
Allison Marziliano ◽  
...  

2010 ◽  
Vol 184 (3) ◽  
pp. 925-929 ◽  
Author(s):  
Matthew K. Tollefson ◽  
Michael L. Blute ◽  
Laureano J. Rangel ◽  
R. Jeffrey Karnes ◽  
Igor Frank

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.


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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