The acute toxicity results of the GETUG-AFU 22 study: A multicenter randomized phase II trial comparing the efficacy of a short hormone therapy in combination with radiotherapy to radiotherapy alone as a salvage treatment for patients with detectable PSA after radical prostatectomy.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 16-16 ◽  
Author(s):  
Stephane Gilles Guerif ◽  
Igor Latorzeff ◽  
Lise Roca ◽  
Djelila Allouache ◽  
Stephane Supiot ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Radical Prostatectomy ◽  
Acute Toxicity ◽  
Hormone Therapy ◽  
Primary Endpoint ◽  
Late Toxicity ◽  
Localized Prostate Cancer ◽  
Free Survival ◽  
Prostate Bed ◽  
Grade 3

16 Background: Radical prostatectomy (RP) is recommended as a standard treatment for localized prostate cancer. However no recommendations exist for pts with detectable PSA after RP. Methods: Pts with localized prostate cancer, treated by RP (R0 or R1), with a PSA level post-RP ≥ 0.2 ng/mL and ≤ 2 ng/mL at randomization and N0 M0 on imaging were included. Pts were randomized (1:1) to radiotherapy (RT) alone (RT arm) or 6 months degarelix hormone therapy (HT) with RT (RT+HT arm). RT consisted of pelvic irradiation (46 Gy in 23 Fr) with a boost on the prostate bed (66 Gy in 33 Fr). The primary endpoint is the event-free survival (EFS). Secondary endpoints are: 5-yr EFS and metastases-free survival, 5 and 10-yr OS, acute and late toxicity (CTCAE V4.0), and QOL. With 122 patients, the probability of selecting the most effective arm is over 80% for a 20% reduction in the HR = 0.80. Results: From Dec-2012 to Sept-2015, 125 pts were included (RT arm: 64 pts; RT+HT arm: 61). Median follow up is 14.7 months (6.2; 33.5). The baseline characteristics are well-balanced: median age was 66 yrs (50-77), all men having an ECOG ≤ 1 (ECOG 0 in 92%), a median Gleason score of 7 (3-9), a median PSA of 0.3 ng/mL (0.09-1.82) post-RP and 0.6 ng/mL (0.12-3.65) at randomization. All pts received 33 Fr of RT. In the RT+HT arm 98.4% of pts received the 6 months of HT planned. All pts were eligible for safety analysis. No grade 4 toxicity or toxic death was reported. Grade 3 acute toxicity, occurring within 6 months of RT, were reported for 11/125 pts (9%): 3/64 pts (5%) in the RT arm and 8/61 pts (13%) in RT+HT arm (NS). Regarding grade 3 toxicities, the following occurred only in the RT+HT arm: erectile dysfunction (3 pts) and urinary incontinence (2 pts); in contrast, dysuria/pollakiuria (2 pts) occurred only in the RT arm. In the RT+HT arm, grade 2 toxicities included hot flushes (8 pts) and decreased libido (7 pts). Conclusions: In terms of acute toxicities the RT+HT arm is well tolerated with the observed toxicities usually expected with concomitant HT. The primary endpoint analysis is expected for 2018. Clinical trial information: NCT01994239.

Late toxicity and quality of life from GETUG-AFU 22 study.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 331-331
Author(s):  
Igor Latorzeff ◽  
Stephane Guerif ◽  
Sandra Pelissier ◽  
Emmanuel Meyer ◽  
Julien Fraisse ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Late Toxicity ◽  
Localized Prostate Cancer ◽  
Efficacy Analysis ◽  
Prostate Bed ◽  
Gu Toxicity ◽  
Significant Difference ◽  
Grade 3

331 Background: Radical prostatectomy (RP) is recommended as a standard treatment for localized prostate cancer. However no recommendations exist for pts with immediate detectable PSA after RP. Methods: Pts with localized prostate cancer, treated by RP (R0 or R1), with a PSA level post-RP ≥0.2 ng/mL and ≤2 ng/mL at randomization and N0 M0 on imaging were included. Pts were randomized (1:1) to radiotherapy (RT) alone (RT arm) or 6 months degarelix hormone therapy (HT) with RT (RT+HT arm). RT consisted of pelvic irradiation (46 Gy in 23 Fr) with a boost on the prostate bed (66 Gy in 33 Fr). The primary endpoint was event-free survival (EFS). Acute and late toxicities were evaluated as secondary endpoints and scored using CTCAE V4.0 scale. Quality of life (QOL) was assessed with QLQ-C30 and QLQ-PR25 questionnaires at 12 and 24 months. Late toxicity was reported at 24 months. Results: From Jan-2013 to Sept-2015, 125 pts were included (RT arm: 64 pts; RT+HT arm: 61). Median follow up is 38 months (31.4; 44). The baseline characteristics are well-balanced between two arms: median age was 66 yrs (50-77), all men having an ECOG ≤1 (ECOG 0 in 92%), a median Gleason score of 7 (3-9), a median PSA of 0.3 ng/mL (0.09-1.82) post-RP and 0.6 ng/mL (0.12-3.65) at randomization. All pts received 33 Fr of RT. In the RT+HT arm 98.4% of pts received the 6 months of HT planned. All pts were eligible for safety analysis. At 24 months, no difference in late genitourinary (GU) or gastrointestinal (GI)toxicity was observed between the two arms (p=0.145) Grade 3 late toxicities were reported for 15/125 pts (12%): 8/64 pts (6.5%) in the RT arm and 7/61 pts (5.5%) in RT+HT arm (NS) and no toxicity grade >3 was observed. Evaluation of QOL was assessable at 12 and 24 months of FU for 80%/89% pts and 59%/77% pts in RT/RT-HT arms respectively. At 12 months QLQ-PR25 HT related symptoms was significantly more important in the RT-HT arm (p=0.04). At 24 months no significant difference in QLQC-30 or QLQ-PR25 analysis was reported. Conclusions:, At 24 months in this phase II trial no significant difference in GI/GU toxicity and.QOL was observed between the two arms. GETUG-AFU 22 efficacy analysis is still pending. Clinical trial information: NCT01994239.

Moderately hypofractionated radiotherapy for localized prostate cancer: Long-term outcomes for 854 consecutive patients treated over 10 years (70 Gy in 2.5 Gy/fraction).

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 78-78
Author(s):  
Omar Y. Mian ◽  
Ibrahim Abu-Gheida ◽  
Rupesh Kotecha ◽  
Michael A. Weller ◽  
Chandana A. Reddy ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Localized Prostate Cancer ◽  
Oncologic Outcomes ◽  
Hypofractionated Radiotherapy ◽  
Clinical Relapse ◽  
Intermediate Risk ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Number Of Patients ◽  
Grade 3

78 Background: Moderately hypofractionated radiotherapy has been increasingly adopted in the management of localized prostate cancer (PCa). We report 10-year outcomes for patients treated with intensity modulation radiation therapy (IMRT) for localized PCa with 70 Gy in 28 fractions at 2.5 Gy/fraction. Methods: This retrospective study included 854 consecutive patients with localized PCa treated with image-guided moderately hypofractionated IMRT at a single institution between 1998 and 2012. Patients with a single intermediate-risk factor were considered to have favorable intermediate-risk (FIR) disease; multiple intermediate-risk factors were considered unfavorable (UIR). Biochemical relapse free survival (bRFS), clinical relapse free survival (cRFS), overall survival (OS) and PCa specific mortality (PCSM) were analyzed used Kaplan-Meier analysis. Grade ≥3 genitourinary (GU) and gastrointestinal (GI) toxicities were recorded (CTCAE v4.03). Results: The median follow-up was 11.3 years (Max. 19 years). For patients with low-risk (LR, 31%), FIR (28%), UIR (12.5%), and high-risk (HR, 28.5%) disease the 10 year bRFS rates were 88%, 78%, 71% and 42%, respectively (p < 0.0001). The number of patients receiving no ADT, 1-6 months, or > 6 months of ADT were 39%, 50%, and 11%, respectively, reflecting practice patterns during this treatment period. The 10-year cRFS were 95%, 91%, 85% and 72% for patients with LR, FIR, UIR, and HR, respectively (p < 0.0001). The 10-year actuarial OS rate was 69% (95% CI 66-73%) and the 10-year PCSM was 6.8% (95% CI 5.1-8.6%) overall. For patients with LR, FIR, UIR and HR disease, the 10 year PCSM rates were 2%, 5%, 5% and 15%. 10-year cumulative incidence of grade ≥3 GU and GI toxicity was 2% and 1%, respectively. Multivariate analysis identified associations between clinical variables (ADT use, PSA nadir < 0.5ng/ml, and ISUP Grade Group) and bRFS, cRFS, and PCSM. Conclusions: Moderately hypofractionated IMRT with daily image guidance for localized PCa demonstrates favorable 10-year oncologic outcomes with a low incidence of toxicity for patients across all risk groups.

125I Brachytherapy for Localized Prostate Cancer: A Single Institution Experience

2013 ◽  
Vol 99 (1) ◽  
pp. 83-87 ◽  
Author(s):  
Alessia Guarneri ◽  
Angela Botticella ◽  
Andrea Riccardo Filippi ◽  
Fernando Munoz ◽  
Giancarlo Beltramo ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Multivariate Analysis ◽  
Early Stage ◽  
Disease Free Survival ◽  
Localized Prostate Cancer ◽  
Free Survival ◽  
Genitourinary Toxicity ◽  
Grade 3 ◽  
Disease Free

Aims and background To evaluate the clinical outcome of a cohort of localized prostate cancer patients treated with 125I permanent brachytherapy at the University of Turin. Methods and study design A retrospective analysis was carried out on 167 consecutive patients with early stage prostate adenocarcinoma who underwent 125I brachytherapy between January 2003 and December 2010. A minimum follow-up of ≥12 months was mandatory for inclusion. Biochemical disease-free survival (defined on the basis of the ASTRO definition and the ASTRO-Phoenix definition) was chosen as the primary end point. Secondary end points were gastrointestinal and genitourinary toxicity (acute and late, defined according to the RTOG scale). Results With a median follow-up of 42 months (range, 13.5–90.7), biochemical disease-free survival at 3 and 5 years was respectively 91.1% and 85.7%, according to the ASTRO definition and 94.5% and 85.1% according to ASTRO-Phoenix definition (for statistical purposes, only the ASTRO definition was used). Hormone treatment and nadir PSA (cutoff of 0.35 ng/ml) were the only factors affecting biochemical disease-free survival both on univariate ( P = 0.02 and P = 0.001, respectively) and multivariate analysis (HR 0.024; P = 0.021 and HR 21.6; P = 0.006, respectively). Only 3.6% of patients experienced ≥grade 3 acute urinary toxicity and 5% ≥grade 3 late urinary toxicity. Prior transurethral prostate resection was the only independent predictor of grade 3 late urinary toxicity on multivariate analysis (HR 0.13; P = 0.009). Conclusions This mono-institutional series confirmed that brachytherapy is an effective and safe treatment modality for localized prostate cancer, with acceptable short- and long-term morbidity rates.

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 Salvage Radiotherapy for Macroscopic Local Recurrence Following Radical Prostatectomy

2021 ◽  
Vol 11 ◽  
Author(s):  
Hind Zaine ◽  
Benjamin Vandendorpe ◽  
Benoit Bataille ◽  
Thomas Lacornerie ◽  
Jennifer Wallet ◽  
...  
Keyword(s):  
Radical Prostatectomy ◽  
Local Recurrence ◽  
Hormone Therapy ◽  
Progression Free Survival ◽  
Salvage Radiotherapy ◽  
Metastatic Progression ◽  
Free Survival ◽  
Prostate Bed ◽  
Concomitant Boost ◽  
Biochemical Progression

IntroductionSalvage radiotherapy is the only curative treatment for biochemical progression after radical prostatectomy. Macroscopic recurrence may be found in the prostatic bed. The purpose of our study is to evaluate the effectiveness of salvage radiotherapy of the prostate bed with a boost to the area of the macroscopic recurrence.Material and MethodsFrom January 2005 to January 2020, 89 patients with macroscopic recurrence in the prostatectomy bed were treated with salvage radiotherapy +/- hormone therapy. The average PSA level prior to radiotherapy was 1.1 ng/mL (SD: 1.6). At the time of biochemical progression, 96% of the patients had a MRI that revealed the macroscopic recurrence, and 58% had an additional choline PET scan. 67.4% of the patients got a boost to the macroscopic nodule, while 32.5% of the patients only underwent radiotherapy of the prostate bed without a boost. The median total dose of radiotherapy was 70 Gy (Min.: 60 – Max.: 74). The most commonly-used regimen was radiotherapy of the prostatectomy bed with a concomitant boost. 48% of the patients were concomitantly treated with hormone therapy.ResultsAfter a median follow-up of 53.7 months, 77 patients were alive and 12 had died, of which 4 following metastatic progression. The 5-year and 8-year survival rates (CI95%) are, respectively, 90.2% (78.9-95.6%) and 69.8% (46.4-84.4%). The 5-year biochemical progression-free survival rate (CI95%) is 50.8% (36.7-63.3). Metastatic recurrence occurred in 11.2% of the patients. We did not find any statistically significant impact from the various known prognostic factors for biochemical progression-free survival. No toxicity with a grade of &gt; or = to 3 was found.ConclusionsOur series is one of the largest published to date. Salvage radiotherapy has its place in the management of patients with biochemical progression with local recurrence in the prostate bed, with an acceptable toxicity profile. The interest of the boost is to be evaluated in prospective trials.

A phase II study of neoadjuvant chemotherapy with docetaxel and bevacizumab in patients (pts) with high-risk localized prostate cancer: A Prostate Cancer Clinical Trials Consortium trial

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 5060-5060
Author(s):  
W. K. Oh ◽  
P. G. Febbo ◽  
J. P. Richie ◽  
F. M. Fennessy ◽  
G. Scibelli ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Radical Prostatectomy ◽  
Phase Ii ◽  
Tumor Volume ◽  
Clinical Stage ◽  
Treatment Options ◽  
Localized Prostate Cancer ◽  
Rectal Injury ◽  
Grade 3

5060 Background: Treatment options for high-risk localized prostate cancer remain inadequate, with the majority of pts relapsing despite surgery or radiation therapy. We conducted a phase II multicenter trial of neoadjuvant docetaxel and bevacizumab prior to radical prostatectomy in pts with high risk localized prostate cancer. Methods: Eligibility included any of the following: PSA > 20 ng/ml or PSA velocity > 2 ng/ml/yr, cT3 disease, any biopsy Gleason 8–10, Gleason 7 with T3 disease by endorectal (er) MRI. Also, >50% biopsy cores involved and either Gleason 7 or PSA >10 or cT2 disease were eligible. Pts were treated with docetaxel 70 mg/m2 q 3weeks x 6 cycles and bevacizumab 15 mg/m2 q 3 weeks x 5 cycles. The primary endpoint was erMRI partial response (PR, defined here as >50% decrease in tumor volume) in a single target lesion after chemotherapy. Results: 42 pts were registered and treated with 220 cycles so far. Median age was 55 yrs (range 41–67). Median Gleason score was 8 (69% with Gleason 8–10 cancer). Median PSA was 10.5 ng/ml (range 2.1–72.5). Clinical stage was T2 in 46% and T3 in 32%. Of 23 evaluable pts to date, the median decline in the maximal tumor volume by erMRI was -45% (range -84% to 110%). 9/23 (39%) patients had PR, and only 1 pt had radiographic progression. Any PSA decline was noted in 22/34 (65%) evaluable pts, with 18% having a >50% decline. Treatment was well-tolerated: 2 pts had grade 3 allergic reactions requiring discontinuation, 3 had febrile neutropenia and 1 had grade 3 hyperglycemia. Mild fatigue was common. Only 1 pt stopped treatment because of a rising PSA. To date, 31 pts have had radical prostatectomy. One had intraoperative bladder neck injury and was treated instead with radiation + hormone therapy. A second pt had an intraoperative rectal injury but completed surgery. Conclusions: Neoadjuvant docetaxel and bevacizumab demonstrates clinical evidence of activity in men with high-risk localized prostate cancer, with a 39% PR rate by erMRI and PSA declines noted in 65%. Treatment was well-tolerated. The study is ongoing and updated data on response, toxicity and pathology will be presented. [Table: see text]

The role of whole pelvic nodal radiotherapy compared with prostate bed only radiotherapy after radical prostatectomy for prostate cancer.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 93-93 ◽  
Author(s):  
Matthieu Caubet ◽  
David Pasquier ◽  
Aurelie Bertaut ◽  
Simon Grobois ◽  
Berardino De Bari ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Radical Prostatectomy ◽  
Postoperative Radiotherapy ◽  
Surgical Margin ◽  
Disease Free Survival ◽  
Positive Surgical Margin ◽  
Free Survival ◽  
Prostate Bed ◽  
Gu Toxicity ◽  
Gi Toxicity

93 Background: In international guidelines, target volumes for postoperative radiotherapy (PORT) after radical prostatectomy concern the bed of the prostate and seminal vesicles. The benefit of whole pelvic nodal radiotherapy (WPRT) in the case of PORT remains uncertain. Methods: We reviewed the charts of all patients diagnosed with high-risk prostate cancer after radical prostatectomy who were selected for PORT and treated with adjuvant radiotherapy (n = 242, 43.1%) or early salvage RT (n = 320, 56.9%) between 2002 and 2011. 111 patients (19.8%) who underwent WPRT were compared with 441 patients (80.2%) who had prostate bed radiotherapy only (PBRT). We examined associations between patient, tumor, and treatment characteristics and biochemical progression-free survival (bPFS), disease-free survival (DFS) and overall survival (OS) with uni- and multivariate analyses using Cox models. Acute and late toxicities were also compared between the two groups. Results: We found a significantly lower rate of acute G2+ gastrointestinal (GI) toxicity with PBRT than with WPRT with neither difference in acute G3+ nor on late GI toxicity. Regarding genitoruinary (GU) toxicity, we found no difference in acute G2+ or G3+ toxicity but rates of late G3+ GU toxicity were significantly lower in PBRT (1.55%) than in WPRT patients (p = 0.035). With a median follow-up of 65.2 months [95% CI: 62.8 - 67.9], a deleterious effect of WPRT was observed on OS (HR = 3.27 [95% CI: 1.44 - 7.45], p = 0.009). We found no impact of WPRT on bPFS (HR = 0.79 [95% CI: 0.49 - 1.25], p = 0.31) or DFS (HR = 0.97 [95% CI: 0.63 - 1.49], p = 0.88). Only a positive surgical margin was an independent prognostic factor for better bPFS. Age≥63 years and WPRT (HR = 2.86 [95% CI: 1.20-6.80], p = 0.018) were independent prognostic factors for worse OS. Conclusions: After radical prostatectomy, we found no difference on bPFS or DFS but lower rates of OS with WPRT compared to PBRT. PBRT must remain the standard of care. The results of RTOG NRG Oncology 0534 should shed light on this unresolved issue.

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