Prostate high dose-rate brachytherapy as monotherapy for low and intermediate risk prostate cancer: Early toxicity and quality-of life results from a randomized phase II clinical trial of one fraction of 19Gy or two fractions of 13.5Gy.
Multi-fraction high dose-rate (HDR) brachytherapy as monotherapy is safe and effective for low and intermediate risk prostate cancer. Two or single fraction regimens have some radiobiological rationale. The purpose is to determine toxicity and effect on health related quality of life (HRQOL) of single fraction 19Gy or 13.5Gy×2.



Eligible patients had low or intermediate risk prostate cancer, prostate volume <60cc, and no androgen deprivation use. 170 patients were randomized to receive either a single 19Gy or two fractions of 13.5Gy 1week apart. HRQOL was measured using the Expanded Prostate Index Composite (EPIC), toxicity with Common Terminology for Adverse Events (CTCAE) v4.0 and urinary symptoms with the International Prostate Symptom Score (IPSS).



Median follow-up is 20months. Grade 2 urinary toxicity occurred in 51% within the first 3months and in 31% thereafter with no significant difference between treatment arms. Ten patients (6%) developed urinary retention in the acute phase, although only 4 (2.4%) required a catheter for more than 48h. One Grade 3 acute (⩽3months) and late (>3months) urinary toxicity occurred. No more than 1% had any Grade 2 GI toxicity. The 2-fraction arm had a higher occurrence of grade 2 erectile dysfunction (29% vs. 11.5%, p=0.0249) and higher IPSS scores for the first year. Mean EPIC urinary scores at 12months decreased by 4.0 and 4.6, and sexual scores decreased by 8 and 15.9 (p=0.035) in the single and 2-fraction arms, respectively. No change occurred in the bowel or hormonal domains.



Single 19Gy and 13.5Gy×2 are both well tolerated. During the first 12months, urinary symptoms and erectile dysfunction are more common in the 2-fraction arm.
Sunnybrook Odette Cancer Centre, University of Toronto, Canada. Electronic address: gerard.morton@sunnybrook.ca.
Gerard
G
Morton
Sunnybrook Odette Cancer Centre, University of Toronto, Canada.
Hans T
HT
Chung
Sunnybrook Odette Cancer Centre, University of Toronto, Canada.
Merrylee
M
McGuffin
Sunnybrook Odette Cancer Centre, University of Toronto, Canada.
Joelle
J
Helou
Sunnybrook Odette Cancer Centre, University of Toronto, Canada.
Laura
L
D'Alimonte
Sunnybrook Odette Cancer Centre, University of Toronto, Canada.
Ananth
A
Ravi
Sunnybrook Odette Cancer Centre, University of Toronto, Canada.
Patrick
P
Cheung
Sunnybrook Odette Cancer Centre, University of Toronto, Canada.
Ewa
E
Szumacher
Sunnybrook Odette Cancer Centre, University of Toronto, Canada.
Stanley
S
Liu
Sunnybrook Odette Cancer Centre, University of Toronto, Canada.
Motasem
M
Al-Hanaqta
Sunnybrook Odette Cancer Centre, University of Toronto, Canada.
Liying
L
Zhang
Sunnybrook Odette Cancer Centre, University of Toronto, Canada.
Alexandre
A
Mamedov
Sunnybrook Odette Cancer Centre, University of Toronto, Canada.
Andrew
A
Loblaw
D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy / Q000379:methods*; D019583:Dose Fractionation, Radiation; D007172:Erectile Dysfunction / Q000517:prevention & control; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011467:Prostate / Q000528:radiation effects; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D011788:Quality of Life; D011879:Radiotherapy Dosage; D012720:Severity of Illness Index; D016896:Treatment Outcome
EPIC; HDR; Monotherapy; Randomized Trial; Toxicity