Efficacy and toxicity from phase II study of dose escalation to intraprostatic tumor nodule in localized prostate cancer.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 102-102
Author(s):  
Julia Murray ◽  
Emma Alexander ◽  
Alison Tree ◽  
Helen McNair ◽  
Vibeke Hansen ◽  
...  
Keyword(s):  
External Beam Radiotherapy ◽  
Late Toxicity ◽  
Free Survival ◽  
Radiation Boost ◽  
Local Progression ◽  
High Risk Disease ◽  
Integrated Boost ◽  
Secondary Endpoints ◽  
Prospective Phase

102 Background: Intra-prostatic boost to dominant nodule is an attractive method for biological dose augmentation. Aim of study was to assess clinical feasibility of radiation boost to mp-MRI visible tumour using external beam radiotherapy. We report a planned analysis of toxicity and efficacy in the first two dose cohorts in this study. Methods: DELINEATE (ISRCTN04483921) was a single centre prospective phase 2 multi-cohort study including standard (Cohort A (A): 74Gy/37F) and moderately hypofractionated (Cohort B (B): 60Gy/20F) prostate image-guided IMRT regimens. Patients treated in A and B received integrated boost of 82Gy and 67Gy to mp-MRI-visible lesions. 55 patients were recruited to A and 158 patients recruited to B; the first 50 sequentially treated patients in B were included in analysis. Duration of androgen deprivation therapy was at clinician discretion. Primary endpoint was RTOG late toxicity at 1 year. Secondary endpoints included acute and late toxicity timepoints and biochemical relapse (BCR) free survival, using Phoenix definition. Treatment related toxicity was measured by RTOG, CTCAE v4 scales, IPSS and EPIC-26. Results: Between July 2011 and January 2015, 105 patients were treated within A&B. Median follow up for A was 74.5 months and 52 months for B. Median age was 71 years (range 57-80). In A and B, there were 27% and 40% of patients respectively classified with NCCN high risk disease. Cumulative RTOG toxicity in Table. 6 patients had BCR (5 patients: A and 1 patient: B). Within A, 1 patient had pelvic nodal progression and 1 local progression; patient in B had local progression. Conclusions: Delivery of intra-prostatic boost to dominant nodule is feasible with acceptable toxicity and good efficacy. Intra-prostatic boost is now part of the randomised phase 3 PIVOTALboost trial (ISRCTN80146950). Clinical trial information: 04483921. [Table: see text]

External Beam Radiotherapy With Endocavitary Boost for Nasopharyngeal Cancer: Treatment Results and Late Toxicity After Extended Follow-Up

2010 ◽  
Vol 78 (3) ◽  
pp. 689-695 ◽  
Author(s):  
Dominic A.X. Schinagl ◽  
Henri A.M. Marres ◽  
Arnoud C. Kappelle ◽  
Matthias A.W. Merkx ◽  
Lucas A.M. Pop ◽  
...  
Keyword(s):  
Cancer Treatment ◽  
External Beam Radiotherapy ◽  
Nasopharyngeal Cancer ◽  
Late Toxicity ◽  
External Beam ◽  
Treatment Results

scholarly journals Impact of superselective intra-arterial and systemic chemoradiotherapy for gingival carcinoma; analysis of treatment outcomes and prognostic factors

2020 ◽  
Author(s):  
Yuki Mukai ◽  
Yuichiro Hayashi ◽  
Izumi Koike ◽  
Toshiyuki Koizumi ◽  
Madoka Sugiura ◽  
...  
Keyword(s):  
Overall Survival ◽  
Multivariate Analysis ◽  
Clinical Stage ◽  
Performance Status ◽  
Univariate Analysis ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Late Toxicity ◽  
Free Survival

Abstract Background: We compared outcomes and toxicities between concurrent retrograde super-selective intra-arterial chemoradiotherapy (IACRT) and concurrent systemic chemoradiotherapy (SCRT) for gingival carcinoma (GC).　Methods: We included 84 consecutive patients who were treated for non-metastatic GC ≥ stage III, from 2006 to 2018, in this retrospective analysis (IACRT group: n=66; SCRT group: n=18).Results: The median follow-up time was 24 (range: 1–124) months. The median prescribed dose was 60 (6–70.2) Gy (IACRT: 60 Gy; SCRT: 69 Gy). There were significant differences between the two groups in terms of 3-year overall survival (OS; IACRT: 78.8%, 95% confidence interval [CI]: 66.0–87.6; SCRT: 50.4%, 95% CI: 27.6–73.0; P = 0.039), progression-free survival (PFS; IACRT: 75.6%, 95% CI: 62.7–85.2; SCRT: 42.0%, 95% CI: 17.7–70.9; P = 0.028) and local control rates (LC; IACRT: 77.2%, 95% CI: 64.2–86.4; SCRT: 42.0%, 95% CI: 17.7–70.9; P = 0.015). In univariate analysis, age ≥ 65 years, decreased performance status (PS) and SCRT were significantly associated with worse outcomes (P < 0.05). In multivariate analysis, age ≥ 65 years, clinical stage IV, and SCRT were significantly correlated with a poor OS rate (P < 0.05). Patients with poorer PS had a significantly worse PFS rate. Regarding acute toxicity, 22 IACRT patients had grade 4 lymphopenia, and osteoradionecrosis was the most common late toxicity in both groups.Conclusions: This is the first report to compare outcomes from IACRT and SCRT among patients with GC. ALL therapy related toxicities were manageable. IACRT is an effective and safe treatment for GC.

Phase Ib/II study of pembrolizumab with lanreotide depot for advanced, progressive gastroenteropancreatic neuroendocrine tumors (PLANET).

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 369-369
Author(s):  
Michael Morse ◽  
Daniel M. Halperin ◽  
Hope Elizabeth Uronis ◽  
David S. Hsu ◽  
Herbert Hurwitz ◽  
...  
Keyword(s):  
External Beam Radiotherapy ◽  
Locoregional Therapy ◽  
Somatostatin Analogue ◽  
Antitumor Effects ◽  
Gastroenteropancreatic Neuroendocrine Tumors ◽  
Best Response ◽  
Secondary Endpoints ◽  
Clinical Trial Information ◽  
Experienced Treatment

369 Background: Pembrolizumab has antitumor activity in a subset of GEP-NETs patients. We hypothesized that the lanreotide, by its antitumor effects and reduction of serotonin, a modulator of immunity, would synergize with pembrolizumab in low/intermediate grade GEPNETs. Methods: GEP-NETs patients who had progressed on a prior somatostatin analogue received lanreotide 90mg sq and pembrolizumab 200mg IV every 3 weeks until progressive disease or intolerable toxicity. The primary endpoint was ORR at any time on study and secondary endpoints were PFS and OS. Results: 22 patients were treated (F/M 10/12; Caucasian/AA/other 10/7/5; GI/pancreatic 14/8; median Ki67 5%, median time since diagnosis 5.3 yrs (IQR 2.3-7.9 yrs)). Prior octreotide LAR/lanreotide/both was administered to 20/1/1. Patients had a median of 2 prior systemic therapies (range 1-9) and six had prior locoregional therapy and 3 external beam radiotherapy. Of the 12 tumors analyzed thus far, 4 had detectable PD-L1 expression and 11 had detectable TILs. A median of 6 pembrolizumab doses (range 2-15) and 7 lanreotide doses (range 2-15) were administered. Six patients experienced treatment related SAEs (abdominal pain, pneumonitis, colitis, and hyperglycemia, all related to the pembrolizumab). Selected treatment related adverse events included: Hypothyroidism 23%, colitis 9%, hyperglycemia 14%, and pneumonitis 5%. Best response by RECIST 1.1 was SD/PD/Not available:39/52/9% and by irRECIST was 43/48/9%. Median PFS was 5.4 months (95% CI 1.7-8.3 mo). The median overall survival at a median follow-up of 15 months was not reached. Peripheral blood immunologic correlates will be reported subsequently. Conclusions: In a population of GEP-NET patients, progressing on a median of 2 prior therapies, including prior somatostatin analogue therapy, a minority of whom had PD-L1 expressing tumors, the combination of lanreotide and pembrolizumab produced stable disease in approximately 40% of patients. No new safety signals were identified. Clinical trial information: NCT03043664.

Surveillance or Metastasis-Directed Therapy for Oligometastatic Prostate Cancer Recurrence: A Prospective, Randomized, Multicenter Phase II Trial

2018 ◽  
Vol 36 (5) ◽  
pp. 446-453 ◽  
Author(s):  
Piet Ost ◽  
Dries Reynders ◽  
Karel Decaestecker ◽  
Valérie Fonteyne ◽  
Nicolaas Lumen ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Specific Antigen ◽  
Phase Iii ◽  
Curative Intent ◽  
Free Survival ◽  
Local Progression ◽  
Randomized Phase Ii

Purpose Retrospective studies suggest that metastasis-directed therapy (MDT) for oligorecurrent prostate cancer (PCa) improves progression-free survival. We aimed to assess the benefit of MDT in a randomized phase II trial. Patients and Methods In this multicenter, randomized, phase II study, patients with asymptomatic PCa were eligible if they had had a biochemical recurrence after primary PCa treatment with curative intent, three or fewer extracranial metastatic lesions on choline positron emission tomography–computed tomography, and serum testosterone levels > 50 ng/mL. Patients were randomly assigned (1:1) to either surveillance or MDT of all detected lesions (surgery or stereotactic body radiotherapy). Surveillance was performed with prostate-specific antigen (PSA) follow-up every 3 months, with repeated imaging at PSA progression or clinical suspicion for progression. Random assignment was balanced dynamically on the basis of two factors: PSA doubling time (≤ 3 v > 3 months) and nodal versus non-nodal metastases. The primary end point was androgen deprivation therapy (ADT)–free survival. ADT was started at symptomatic progression, progression to more than three metastases, or local progression of known metastases. Results Between August 2012 and August 2015, 62 patients were enrolled. At a median follow-up time of 3 years (interquartile range, 2.3-3.75 years), the median ADT-free survival was 13 months (80% CI, 12 to 17 months) for the surveillance group and 21 months (80% CI, 14 to 29 months) for the MDT group (hazard ratio, 0.60 [80% CI, 0.40 to 0.90]; log-rank P = .11). Quality of life was similar between arms at baseline and remained comparable at 3-month and 1-year follow-up. Six patients developed grade 1 toxicity in the MDT arm. No grade 2 to 5 toxicity was observed. Conclusion ADT-free survival was longer with MDT than with surveillance alone for oligorecurrent PCa, suggesting that MDT should be explored further in phase III trials.

scholarly journals Impact of superselective intra-arterial and systemic chemoradiotherapy for gingival carcinoma; analysis of treatment outcomes and prognostic factors

BMC Cancer ◽  
2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Yuki Mukai ◽  
Yuichiro Hayashi ◽  
Izumi Koike ◽  
Toshiyuki Koizumi ◽  
Madoka Sugiura ◽  
...  
Keyword(s):  
Overall Survival ◽  
Multivariate Analysis ◽  
Clinical Stage ◽  
Performance Status ◽  
Univariate Analysis ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Late Toxicity ◽  
Free Survival

Abstract Background We compared outcomes and toxicities between concurrent retrograde super-selective intra-arterial chemoradiotherapy (IACRT) and concurrent systemic chemoradiotherapy (SCRT) for gingival carcinoma (GC). Methods We included 84 consecutive patients who were treated for non-metastatic GC ≥ stage III, from 2006 to 2018, in this retrospective analysis (IACRT group: n = 66; SCRT group: n = 18). Results The median follow-up time was 24 (range: 1–124) months. The median prescribed dose was 60 (6–70.2) Gy (IACRT: 60 Gy; SCRT: 69 Gy). There were significant differences between the two groups in terms of 3-year overall survival (OS; IACRT: 78.8, 95% confidence interval [CI]: 66.0–87.6; SCRT: 50.4, 95% CI: 27.6–73.0; P = 0.039), progression-free survival (PFS; IACRT: 75.6, 95% CI: 62.7–85.2; SCRT: 42.0, 95% CI: 17.7–70.9; P = 0.028) and local control rates (LC; IACRT: 77.2, 95% CI: 64.2–86.4; SCRT: 42.0, 95% CI: 17.7–70.9; P = 0.015). In univariate analysis, age ≥ 65 years, decreased performance status (PS) and SCRT were significantly associated with worse outcomes (P < 0.05). In multivariate analysis, age ≥ 65 years, clinical stage IV, and SCRT were significantly correlated with a poor OS rate (P < 0.05). Patients with poorer PS had a significantly worse PFS rate. Regarding acute toxicity, 22 IACRT patients had grade 4 lymphopenia, and osteoradionecrosis was the most common late toxicity in both groups. Conclusions This is the first report to compare outcomes from IACRT and SCRT among patients with GC. ALL therapy related toxicities were manageable. IACRT is an effective and safe treatment for GC.

Radiation Therapy Oncology Group (RTOG) 9413: Randomized trial comparing whole pelvic radiotherapy (WPRT) to prostate only (PORT) and neoadjuvant hormone therapy (NHT) to adjuvant hormone therapy (AHT).

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 96-96 ◽  
Author(s):  
Mack Roach ◽  
Yan Yan ◽  
Colleen Anne Lawton ◽  
I-Chow Joe Hsu ◽  
Robert A. Lustig ◽  
...  
Keyword(s):  
Hormone Therapy ◽  
Radiation Therapy Oncology Group ◽  
Progression Free Survival ◽  
Late Toxicity ◽  
Adjuvant Hormone Therapy ◽  
Entire Cohort ◽  
Local Progression ◽  
Increased Risk ◽  
First Occurrence ◽  
Secondary Endpoints

96 Background: RTOG 9413 demonstrated that NHT+WPRT improved progression-free survival (PFS) compared to NHT+PORT, WPRT+AHT and PORT+AHT. We update primary and secondary endpoints (SE): biochemical failure (BF), time to metastasis (Mets), prostate specific survival (PSS) and overall survival (OS). Methods: RTOG 9413 opened on April 1, 1995, and closed on June 1, 1999, with 1275 eligible pts who were required to have a risk of lymph node (LN) involvement >15% but LN-positive pts were ineligible. They were stratified by T Stage, GS (<7 vs 7-10) and PSA (>30 vs < 30ng/ml) and randomized to PORT +/- WPRT to 70 Gy and NHT or AHT. Hormonal therapy (HT) consisted of flutamide, and leuprolide or goserelin, monthly x 4 mos, beginning 2 mos before RT and continued until RT is completed (NHT) or beginning at the completion of RT (AHT). For this analysis PFS was defined as the first occurrence of local/regional or LN progression, Mets, BF (PSA nadir+2ng/mL), or death from any cause. PSS is defined as a death due to prostate cancer, treatment toxicity or unknown causes with local progression, Mets or BF. Results: For the entire cohort WPRT or NHT did not appear to improve any endpoint compared with PORT or AHT, (although there was a trend for improvement in regional failure for WPRT vs PORT, (p=0.07)). However, there were complex sequence/volume dependent interactions between HT and RT and statistically significant differences between the 4 arms in PFS (p=0.03). There was a trend for NHT+WPRT to improved PFS compared to NHT+PO (p=0.07) and WPRT+AHT (p=0.04). NHT+WPRT was associated with an increased risk of late GI toxicity, 5% compared to 0.6%, 2% and 2% for NHT+PORT, WPRT+AHT and PORT+AHT (p<0.001) but not in GU late toxicity. Conclusions: The failure to improve SE or definitively impact PFS may reflect sample size, pt selection, and inadequate RT doses. RTOG 0924 will test the hypotheses that modern techniques and doses will improve OS without increasing late toxicity.

The SEMITEP trial: De-escalating chemotherapy in low-volume metastatic seminoma based on early FDG-PET.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 387-387 ◽  
Author(s):  
Yohann Loriot ◽  
Matthieu Texier ◽  
Stephane Culine ◽  
Aude Flechon ◽  
Thierry Nguyen ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Good Prognosis ◽  
Free Survival ◽  
Interim Pet ◽  
Phase 2 Trial ◽  
Positron Emission ◽  
Secondary Endpoints ◽  
Low Volume ◽  
Group 2

387 Background: A negative FDG-positron emission tomography/computerized tomography (PET) predicts the absence of viable seminoma cells after chemotherapy in men with metastatic seminoma. In this study, we assessed whether patients (pts) with low-volume metastatic seminoma can be treated with 2 cycles of etoposide-cisplatin (EP) followed by only one cycle of carboplatin (CARBO) on the basis of a negative interim PET, thereby limiting the burden of toxicity. Methods: In this non-randomised, multiple-center, phase 2 trial (NCT01887340), we enrolled pts with low-volume metastatic seminoma (with good prognosis according to IGCCCG and the Medical Research Council classifications). All pts with baseline PET-positive received EP for two cycles. After completion of first two cycles, pts underwent a second PET to assess response. Patients with a persistent positive PET (based on local review) proceeded directly to two additional EP cycles (for a total of 4); those who achieved a PET-negative received only one cycle of CARBO (AUC=7). The primary outcome was the proportion of pts who were PET-negative on interim PET and received de-escalating chemotherapy. Secondary endpoints include progression-free survival (PFS) and overall survival (OS). Results: Between June 2013 and July 2017, 102 pts were enrolled in the study. Three pts were deemed ineligible or not evaluable and thus 99 patients received treatment. After 2 first EP cycles, PET was available in 94 pts. Interim PET was negative in 68 pts (72%) and positive in 26 pts (28%). Overall, 63 pts (67.0%; 95% CI 57.5-76.5) were PET-negative and proceeded to one single cycle of CARBO. Overall, 24 (25.5%, 95% CI 17.1-34.9) patients had a PET positive after 2 EP and received 2 additional cycles of EP. After a median follow-up of 34.4 months, only 8 patients relapsed (2 in EP group and 6 in CARBO group). 2-year PFS rates were respectively 93.7% (95% CI 84.9-97.5) in the CARBO group and 92.9% (95% CI 77.4-98.0) in the EP group. Only one patient died during the 2 first cycles. Conclusions: De-escalating treatment based on a negative PET after 2 cycles of chemotherapy appears to be safe and feasible in the majority of patients with low-volume metastatic seminoma. Clinical trial information: NCT01887340.

scholarly journals Dose Escalated Carbon Ion Radiotherapy for Localized Prostate Cancer in Shanghai Proton and Heavy Ion Center: Toxicity and Efficacy Outcomes At Two Years.

2021 ◽  
Author(s):  
Ping Li ◽  
Zhengshan Hong ◽  
Yongqiang Li ◽  
Xiaomao Guo ◽  
Shen Fu ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Late Toxicity ◽  
Heavy Ion ◽  
Carbon Ion Radiotherapy ◽  
Localized Prostate Cancer ◽  
Cancer Specific Survival ◽  
Free Survival ◽  
Carbon Ion ◽  
Spot Scanning

Abstract Purpose: The purpose of this study was to prospectively analyze the safety and feasibility of spot scanning carbon ion radiotherapy (CIRT) for patients with localized prostate cancer.Methods: 118 localized prostate cancer patients treated with spot scanning CIRT at Shanghai Proton and Heavy Ion Center (SPHIC) were enrolled in this dose escalated study. The dose was gradually increased from 59.2GyE to 65.6GyE in 16 fractions. The primary endpoint was the acute and late toxicities. Secondary endpoints were biochemical relapse free survival (bRFS), distant metastasis free survival (DMFS), prostate cancer-specific survival (PCSS), and overall survival (OS).Results: The median follow-up time was 30.2 months (4.8-62.7 months). Acute grade 1 and 2 genitourinary (GU) toxicities were 15.3% and 18.6%, while acute grade 1 and 2 gastrointestinal (GI) toxicities were 2.5% and 0%, respectively. Late grade 1 and 2 GU toxicities were 4.2% and 1.7%, respectively. No late GI toxicity were observed. There were no cases of severe acute or late toxicity (≥grade 3). The significant association was not found between the factors and the acute GU toxicities except for CTV volume (p=0.031) on multivariate analysis. The 2-year bRFS, DMFS, PCSS, OS were 100%, 100%, 100% and 98.8%, respectively.Conclusion: The 2 years’ outcomes are encouraging, providing additional and useful information on the feasibility and safety of spot scanning CIRT for prostate cancer. Long term follow-up and prospective multi-institutional data are warranted to reinforce the role of CIRT in the management of localized prostate cancer.Trial registration: Clinicaltrial, NCT02739659. Registered 15 April 2016

scholarly journals NIMG-03. PROSPECTIVE PHASE II RANDOMIZED TRIAL COMPARING PROTON THERAPY VS. PHOTON IMRT FOR GBM: SECONDARY ANALYSIS COMPARISON OF PROGRESSION FREE SURVIVAL BETWEEN RANO VS. CLINICAL AND RADIOLOGICAL ASSESSMENT

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi161-vi162
Author(s):  
Karine Al Feghali ◽  
James Randall ◽  
Jeffrey Wefel ◽  
Nandita Guha-Thakurta ◽  
David Grosshans ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Tumor Progression ◽  
Secondary Analysis ◽  
Progression Free Survival ◽  
Radiological Assessment ◽  
Clinical Progression ◽  
Free Survival ◽  
Rano Criteria ◽  
Prospective Phase

Abstract PURPOSE To compare tumor progression based on clinical radiological assessment and on Response Assessment in Neuro-Oncology (RANO) criteria between GBM patients treated with proton radiotherapy (PT) vs. photon intensity modulated radiotherapy (IMRT). METHODS Eligible patients were enrolled on the described prospective phase II trial and had MR imaging at baseline and follow-up beyond 12 weeks from treatment completion. ‘Clinical’ progression was based on a radiology report of progression in combination with changes in treatment due to suspected disease progression. A single blinded observer applied RANO criteria to determine the RANO-based tumor progression. RESULTS Of 90 enrolled patients, 66 were evaluable, with median follow-up of 19.8 (Range: 3.2–65.1) months; median of 22.6 months for PT (n=25) vs. 18.9 months for IMRT (n=41). Median time to progression (TTP) was 7.9 months based on clinical progression criteria (8.1 months IMRT, 6.3 months PT) and 7.2 months (7.3 months IMRT, 5.7 months PT) by RANO criteria (p=ns for all). Median ‘clinical’ progression-free survival (PFS) was 8.7 (Range: 6.4–11.1) months; 8.9 months IMRT vs. 8.7 months PT (p=0.065). Median RANO PFS was 8.3 (range, 5.8–11.6) months: 8.3 months IMRT vs. 6.9 months PT (p=0.226). There were 14 discrepant cases: 3 had progression based on ‘clinical’ but not RANO criteria, and 11 had progression based on RANO but not ‘clinical’ criteria. CONCLUSION Based on this secondary analysis of a randomized trial of PT vs. IMRT for GBM, there was no difference in tumor progression relative to treatment technique used. There was no statistical difference in PFS noted between clinical and RANO-based assessments, but RANO criteria identified progression more often than clinical assessment, and TTP was shortened with the use of RANO criteria alone. Further development of tumor assessment tools that improve consistency and accuracy of determining tumor progression are needed to guide therapeutic trials in GBM.

Combined brachytherapy and external beam radiation for prostate cancer in a community setting

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e16147-e16147
Author(s):  
G. J. Kubicek ◽  
G. J. Kubicek ◽  
S. Brown ◽  
S. Redfield
Keyword(s):  
Prostate Cancer ◽  
External Beam Radiotherapy ◽  
Treatment Options ◽  
Community Setting ◽  
Late Toxicity ◽  
Biochemical Failure ◽  
External Beam Radiation ◽  
External Beam ◽  
Beam Radiation

e16147 Background: Prostate cancer is the most common male malignancy, and there is no one standard treatment modality. One treatment option is the combination of external beam radiotherapy and permanent transperineal brachytherapy seed implant Methods: Retrospective review of prostate cancer and side effect outcomes at a single institution in the community setting. All patients were treated with a combination of low dose rate transperineal brachytherapy seed placement and external beam radiation. Results: A total of 897 patients were analyzed, 781 had a minimum follow-up of one year. Median pre-treatment PSA was 8.1 (range 0.3 to 106) and the median Gleason score was 6. With a median follow-up of 3.6 years, 33 (3.4 %) patients had biochemical failure based on the phoenix definition of Nadir + 2. Not including impotence, acute toxicity greater than or equal to Grade 2 was seen in 115 patients (102 GU and 13 GI) and 193 patients had late toxicity greater than or equal to Grade 2 (155 GU and 38 GI). 563 patients received hormone therapy prior to or concurrent with the radiation. Conclusions: This is the largest series reporting on the outcome of combination brachytherpay implant and external beam radiation in the treatment of prostate cancer. Combination treatment using brachytherapy and external beam radiation is well tolerated, with a low rate of biochemical failure and should be considered one of the treatment options for prostate cancer. No significant financial relationships to disclose.

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