Genitourinary Cancer

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SU_27_2273 - A Phase II Randomized Pilot Study Comparing High-Dose Rate Brachytherapy and Low-Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer

Sunday, October 21
1:15 PM - 2:45 PM
Location: Innovation Hub, Exhibit Hall 3

A Phase II Randomized Pilot Study Comparing High-Dose Rate Brachytherapy and Low-Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer
L. Hathout1, O. M. E. E. Mahmoud2, M. Barkati3, P. Després4, K. Mbodji5, A. G. Martin4, W. Foster4, F. Lacroix4, G. Delouya6, D. Taussky6, G. Morton7, I. Vergalasova8, and E. Vigneault4; 1Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, 2Rutgers Newark University Hospital, Newark, NJ, 3Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada, 4Radiation Oncology, CHU de Quebec, Quebec, QC, Canada, 5Cancer Research Centre, University of Laval, Quebec, QC, Canada, 6Centre Hospitalier de l'Universite de Montreal, Montreal, QC, Canada, 7Sunnybrook Odette Cancer Centre, Toronto, ON, Canada, 8Rutgers Robert Wood Johnson University Hospital & Rutgers Cancer Institue of New Jersey, Department of Radiation Oncology, New Brunswick, NJ

Purpose/Objective(s): To compare Quality of Life (QoL) and urinary toxicity outcomes of High Dose Rate Brachytherapy (HDRB) monotherapy to Low Dose-Rate brachytherapy (LDRB) for localized prostate cancer in a multi-institutional phase II prospective randomized trial.

Materials/Methods: Patients with low risk and favorable intermediate risk disease defined as clinical stage T1-T2, Gleason ≤ 7 and PSA ≤ 20 ng/mL were accrued. Patients with Gleason 7 (4+3) and with ≥ 60% of positive cores involved were deemed ineligible. Patients were randomized between LDRB (144 Gy) and HDRB (19 Gy) in a single fraction to the prostate gland. QoL and urinary toxicity were recorded at baseline and at 1, 3 , 6 and 12 months using the Expanded Prostate Cancer Index Composite (EPIC) 26 scoring and the International Prostate Symptom Score (IPSS). The primary objective was to report QoL in the urinary domain at 3 months between patients treated with HDRB and LDRB. The 3 months point was chosen as the primary endpoint based on several studies revealing peak urinary symptoms at 3 to 6 months. Independent samples t-test and repeated measures ANOVA were performed for continuous variables (EPIC and IPSS). Time to IPSS resolution defined as return to its baseline score +/- 5 points was calculated using Kaplan-Meier survival curves with log-rank test. A P value of ≤ 0.05 was considered significant.

Results: A total of 31 patients were randomized across three Canadian centres. LDRB was delivered to 15 patients and HDRB to 16 patients. The mean scores of IPSS, EPIC urinary incontinence, EPIC urinary irritative, EPIC bowel habits and EPIC sexual function at baseline were 6.2 (0-16), 95.32 (54.25-100), 89.9 (68-100), 97.6 (95.9-99.2) and 67.9 (59.2-76.8) respectively; not significantly different between groups. At 3 months, patients treated with LDRB compared to HDRB had a higher IPSS score (mean 15.4 vs 6.3 respectively, p=0.0005) and lower EPIC urinary irritative score (mean 69.8 vs 84.6 respectively, p=0.038). On repeated measures at 1, 3, 6 and 12 months, the IPSS (p=0.006) and EPIC urinary irritative scores (p= 0.04) were significantly better in the HDR arm, translating into a lower urinary toxicity profile as shown in Figure 1. There were no significant differences in the EPIC urinary incontinence, sexual function or bowel habits scores between the 2 groups at any measured time point. Time to IPSS resolution was significantly shorter in the HDRB group (mean = 3.3 months) compared to the LDRB group (mean= 6.5 months) (p=0.013).

Conclusion: HDRB monotherapy is a potential alternative to LDRB in low risk and favorable intermediate risk prostate cancer with a significantly lower urinary toxicity profile and higher QoL in the first 12 months. Long-term toxicity, treatment outcome determined by the biochemical recurrence-free survival and prostate biopsy at 36 months will be reported after achieving a longer follow up.

Author Disclosure: L. Hathout: None. O.M. Mahmoud: None. P. Després: None. K. Mbodji: None. G. Delouya: Partner; YAD Technologies. Research Grant; Janssen, Astellas, Ferring, Bayer. Honoraria; Janssen, Astellas, Ferring, Bayer. Travel Expenses; Janssen, Astellas, Ferring, Bayer. Member of the Board of directors; CARO. G. Morton: Independent Contractor; Sunnybrook Odette Cancer Centre. Honoraria; Astra Zeneca, Abbvie. Regional Director; Canadian Association of Radiation Oncologists. I. Vergalasova: None. E. Vigneault: Independent Contractor; CHUQ L'Hotel Dieu de Québec. Honoraria; Abbvie. Advisory Board; Abbvie.

Lara Hathout, MD, FRCPC

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Rutgers CINJ: Assistant Professor: Employee

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SU_27_2273 - A Phase II Randomized Pilot Study Comparing High-Dose Rate Brachytherapy and Low-Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer



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