scholarly journals Proton Therapy of Prostate and Pelvic Lymph Nodes for High Risk Prostate Cancer: Acute Toxicity

2021 ◽  
Vol 8 (2) ◽  
pp. 41-50
Author(s):  
Richard Choo ◽  
David W. Hillman ◽  
Thomas Daniels ◽  
Carlos Vargas ◽  
Jean Claude Rwigema ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Acute Toxicity ◽  
Lymph Nodes ◽  
Seminal Vesicles ◽  
Pelvic Lymph Nodes ◽  
Gu Toxicity ◽  
Risk Prostate Cancer ◽  
Gi Toxicity ◽  
Grade 3

Abstract Purpose To assess acute gastrointestinal (GI) and genitourinary (GU) toxicities of intensity-modulated proton therapy (IMPT) targeting the prostate/seminal vesicles and pelvic lymph nodes for prostate cancer. Materials and Methods A prospective study (ClinicalTrials.gov: NCT02874014), evaluating moderately hypofractionated IMPT for high-risk or unfavorable intermediate-risk prostate cancer, accrued a target sample size of 56 patients. The prostate/seminal vesicles and pelvic lymph nodes were treated simultaneously with 6750 and 4500 centigray radiobiologic equivalent (cGyRBE), respectively, in 25 daily fractions. All received androgen-deprivation therapy. Acute GI and GU toxicities were prospectively assessed from 7 GI and 9 GU categories of the Common Terminology Criteria for Adverse Events (version 4), at baseline, weekly during radiotherapy, and 3-month after radiotherapy. Fisher exact tests were used for comparisons of categorical data. Results Median age was 75 years. Median follow-up was 25 months. Fifty-five patients were available for acute toxicity assessment. Sixty-two percent and 2%, respectively, experienced acute grade 1 and 2 GI toxicity. Grade 2 GI toxicity was proctitis. Sixty-five percent and 35%, respectively, had acute grade 1 and 2 GU toxicity. The 3 most frequent grade 2 GU toxicities were urinary frequency, urgency, and obstructive symptoms. None had acute grade ≥ 3 GI or GU toxicity. The presence of baseline GI and GU symptoms was associated with a greater likelihood of experiencing acute GI and GU toxicity, respectively. Of 45 patients with baseline GU symptoms, 44% experienced acute grade 2 GU toxicity, compared with only 10% among 10 with no baseline GU symptoms (P = 0.07). Although acute grade 1 and 2 GI and GU toxicities were common during radiotherapy, most resolved at 3 months after radiotherapy. Conclusion A moderately hypofractionated IMPT targeting the prostate/seminal vesicles and regional pelvic lymph nodes was well tolerated with no acute grade ≥ 3 GI or GU toxicity. Patients with baseline GU symptoms had a higher rate of acute grade 2 GU toxicity.

Clinical outcomes and late toxicity of hypofractionated intensity-modulated radiotherapy for high-risk prostate cancer.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 56-56
Author(s):  
Michael Wang ◽  
Robert Pearcey ◽  
Nadeem Pervez ◽  
Don Yee ◽  
Alina Mihai ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Intensity Modulated Radiotherapy ◽  
Late Toxicity ◽  
Seminal Vesicles ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer ◽  
Gi Toxicity ◽  
Grade 3

56 Background: Since prostate cancer has intrinsic high radiation-fraction sensitivity, hypofractionated radiotherapy (HFRT) could offer treatment advantages. However, dose-escalated HFRT may increase risks of late genitourinary (GU) and gastrointestinal (GI) toxicity. Intensity-modulated radiotherapy (IMRT) can potentially deliver dose-escalated HFRT without increasing late toxicities. This study’s acute toxicity data was previously published. We now present five-year efficacy results and late toxicity data for prostate cancer patients treated with HFRT using IMRT. Methods: From 2005-2012, our Phase II prospective study enrolled one hundred patients with either high risk disease (one or more of: Stage ≥ T3, Gleason ≥ 8, or PSA ≥ 20 ng/mL) or high tier intermediate risk disease (Gleason 7 and PSA ≥ 15 ng/mL). All patients received HFRT using IMRT in 25 daily fractions. Sixty patients received 68 Gy to the prostate and proximal seminal vesicles, with simultaneous integrated boost (SIB) of 45 Gy to pelvic lymph nodes and distal seminal vesicles. Forty patients received 68 Gy to the prostate, and a SIB of 50 Gy to pelvic lymph nodes and seminal vesicles. Adjuvant hormonal therapy was given for two to three years. Biochemical failure was determined by the Phoenix definition. Late toxicity scores were recorded every 6 months after completing RT. Results: Median age of patients was 67 years. 33% had Stage ≥ T3, 52% had Gleason ≥ 8, and 44% had PSA ≥ 20 ng/mL. After a median follow-up of 5.4 years, median PSA at last follow-up was 0.10 ng/mL. Five-year biochemical control rate (BCR) was 91.8%, five-year progression-free survival (PFS) was 92.8%, and five-year overall survival (OS) was 88.7%. Five-year cumulative incidence of Grade ≥ 3 GU and GI toxicity were 13.0% and 16.7% respectively. At the five-year efficacy endpoint, ongoing Grade ≥ 3 GU and GI toxicity were 1.9% and 0% respectively. Conclusions: Dose-escalated HFRT using IMRT results in favourable five-year BCR, PFS, and OS for patients with localized high-risk prostate cancer, and is well-tolerated with acceptable late GU and GI toxicity. These findings support ongoing Phase III trials that are assessing the clinical use of IMRT-based HFRT. Clinical trial information: NCT00126802.

Planning outcomes and acute toxicity of intensity-modulated radiotherapy (IMRT) for treatment of bladder and pelvic lymph nodes.

2011 ◽  
Vol 29 (7_suppl) ◽  
pp. 297-297
Author(s):  
V. Harris ◽  
F. McDonald ◽  
V. Hansen ◽  
H. Taylor ◽  
R. A. Huddart
Keyword(s):  
High Risk ◽  
Acute Toxicity ◽  
Lymph Nodes ◽  
Organs At Risk ◽  
Simultaneous Treatment ◽  
Comparable Rate ◽  
Pelvic Lymph Nodes ◽  
Dose Volume Histograms ◽  
Gu Toxicity ◽  
Dose Constraints

297 Background: We implemented an IMRT protocol for simultaneous treatment of bladder and pelvic lymph nodes (LN) and report the planning outcomes and acute toxicity of patients treated using this technique. Methods: 13 patients were treated with a 5-field step and shoot IMRT technique. Inclusion criteria were: radiological evidence of pelvic LN metastases; stage T3/T4; high risk pathology or post-cystectomy with persistent/recurrent disease. Anisotropic margins were applied to the whole bladder CTV (0.5 cm laterally/inferiorly, 1 cm posteriorly, 1.5 cm superiorly/anteriorly) to create PTV1. 0.5 cm margins were applied to the pelvic LN CTV to create PTV2. PTVs 1/2 were prescribed 52 Gy in 32 fractions. 1 cm margins were applied to the involved bladder to create PTV3 (prescribed 64Gy). 0.5 cm margins were applied to the involved LN volumes to create PTV4 (prescribed 60 Gy). Post cystectomy patients were planned using PTVs 2/4 only. Dose volume histograms for organs at risk (rectum, femoral heads and other bowel) were calculated and compared with local dose constraints. Acute toxicity was assessed according to common toxicity criteria v3.0 and recorded weekly during treatment. Treatment verification was performed by cone beam CT. Results: All treatment plans achieved target coverage of > 95% volume to > 95% prescription dose for each PTV. All patients achieved rectal and femoral head dose constraints. 2 patients did not meet V45 other bowel constraints but proceeded with treatment as all other dose limits were achieved. At the time of abstract submission 13 patients had completed treatment. 2 were treated for relapse post-cystectomy and did not have GU toxicities recorded. Maximum experienced acute toxicities were recorded. 9/11 patients experienced acute GU toxicity (G1=3, G2=1, G3=5). 6/13 patients experienced acute GI toxicity (G1=3, G2=3). 9/13 patients developed other acute toxicities (G1=7, G2=2). No patients developed ≥G3 non-GU toxicity. Conclusions: Bladder and pelvic LN IMRT allows patients with high risk locoregional bladder cancer to meet preset dose constraints, appears feasible and has a comparable rate of acute toxicity to conventional bladder-only radiotherapy treatment. No significant financial relationships to disclose.

Comparison of acute toxicity in patients treated with a 4-field box or IMRT to deliver elective pelvic nodal irradiation for localized high-risk prostate cancer.

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 69-69
Author(s):  
Suneil Jain ◽  
Patrick Cheung ◽  
D. Andrew Loblaw ◽  
Gerard Morton ◽  
Cyril Danjoux ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Acute Toxicity ◽  
Urinary Frequency ◽  
High Risk Prostate Cancer ◽  
Risk Prostate Cancer ◽  
Target Volumes ◽  
Common Technique ◽  
Grade 3 ◽  
New Literature

69 Background: To deliver elective pelvic nodal irradiation (EPNI), a 4-field box (4FB) has been a common technique. More recently, there are increasing reports of using IMRT to deliver EPNI. Even though studies show a clear dosimetric benefit to bowel and bladder, there is a lack of good data demonstrating decreased toxicity with the use of IMRT in this setting. Methods: From 2004-2010, 230 patients with localized high risk prostate cancer were enrolled into 3 sequential prospective phase I/II trials of delivering EPNI (45 Gy) along with a concomitant hypofractionated IMRT boost to the prostate (67.5 Gy total) in 25 fractions over 5 weeks time. All patients were to receive 3 years of adjuvant androgen deprivation. During the accrual period, the method used to deliver the EPNI portion of the treatment changed as new literature emerged about target volumes for EPNI. The 3 methods used to deliver EPNI in this large cohort were 1) 4FB, 2) IMRT with 2cm CTV margins around the pelvic vessels as suggested by Shih et al (IMRT-Shih), and 3) IMRT with nodal volumes as suggested by RTOG (IMRT-RTOG). Common Terminology Criteria for Adverse Events v3.0 was used to assess acute toxicity prospectively during treatment and then at 3 months. Results: For EPNI, 94 patients were treated with a 4FB, 53 were treated with IMRT-Shih, and 83 were treated with IMRT-RTOG. There were no acute grade 3 GI toxicities. Patients in the 4FB group had higher rates of acute grade ≥ 2 proctitis compared to the IMRT-Shih and IMRT-RTOG groups (16.0% vs 2.0% vs 2.4%, p=0.0009). The 4FB group also had higher rates of grade ≥ 2 flatulence compared to the 2 other IMRT groups (17.0% vs 7.6% vs 0%, p<0.0001). With regards to acute GU toxicities, patients in the 4FB group had higher rates of grade ≥ 3 urinary frequency compared to the 2 other IMRT groups (5.3% vs 0% vs 0%, p=0.027). Conclusions: In this non-randomized comparison, IMRT resulted in statistically significant decreases in acute proctitis, flatulence, and urinary frequency when compared to a 4FB technique to deliver EPNI in localized high risk prostate cancer. Analysis for possible confounding factors will be performed.

Hypofractionated, dose escalation radiotherapy for high-risk prostate cancer: The primary endpoint of a group led phase III trial. (PCS5).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 123-123 ◽  
Author(s):  
Tamim Niazi ◽  
Abdenour Nabid ◽  
Redouane Bettahar ◽  
Linda S. Vincent ◽  
Andre-Guy Martin ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Lymph Nodes ◽  
Primary Endpoint ◽  
Dose Escalation ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Pelvic Lymph Nodes ◽  
Androgen Suppression ◽  
Grade 3

123 Background: The low α\β ratio of prostate cancer (PCa), 1.5-2, suggests high radiation-fraction sensitivity and predicts a therapeutic advantage of hypofractionated radiation treatment (HFRT). Most available data of moderate HFRT have focused on low, intermediate and/or mixed risk groups. We therefore conducted the first randomized trial of moderately HFRT in high-risk PCa patients and present the primary safety analysis of side effects at 2 years. Methods: We conducted a Canadian multi-centric phase III trial of conventional fractionated radiation therapy (CFRT) vs. intensity-modulated HFRT in men with high-risk PCa as per NCCN definition. From February 2012 to March 2015, 329 patients were randomized in a 1:1 ratio to receive either CFRT or HFRT. All patients received neo-adjuvant, concurrent and adjuvant androgen suppression, with a median duration of 24 months. CFRT consisted of 76 Gy in 2 Gy per fraction to the prostate where 46 Gy was delivered to the pelvic lymph nodes. HFRT consisted of concomitant dose escalation of 68 Gy in 2.72 Gy per fraction to the prostate and 45 Gy, in 1.8Gy per fraction to the pelvic lymph nodes. The primary endpoint was to compare the toxicities at 6 months and at 24 months using the CTCAE v.4. Results: Of the329 patients, 164 were randomized to HFRT and 165 to CFRT. The minimum, median and maximum follow-up were 24, 40 and 60 months respectively. At 24 months, 12 patients in the CFRT arm and 15 patients in the HFRT arm had grade 2 or worse gastrointestinal (GI)-related adverse events (HR:1.32 [0.62.2.83] 95% CI; P=NS). Similarly, 11 patients in the CFRT arm and 3 patients in HFRT arm had grade 2 or higher genitourinary (GU) toxicities (HR:0.26 [0.07-0.94] 95% CI; P=0.037). In the HFRT arm, there were 3 grade 3 GI and one grade 3 GU related toxicities. In the CFRT arm there were 3 grade 3 GU and no grade 3 GI related toxicities. There were no grade 4 toxicities in either arm. Conclusions: This is the first hypofractionated dose escalated radiotherapy study in high-risk PCa patients treated with contemporary radiation and androgen suppression. Our results indicate that moderate HFRT to high risk PCa patients is equally well tolerated as CFRT at 2 years. Clinical trial information: NCT01444820.

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