(Pilepich et al. 1987)
Design: Randomized controlled trial (therapy), evidence level: 1+
Country: United States, setting: Tertiary care
Inclusion criteria Patients with stage A2 (T1bN0M0 ) or B (T2N0M0) prostate cancer, according to Jewett-Whitmore staging (i.e. no evidence of nodal involvement by lymphangiogram or surgical staging). Patients were entered into the trial (RTOG 77-06) between 1978 and 1983. Randomization was stratified by histological grade, hormonal therapy and method of node evaluation (lymphangiogram or staging laporotomy).
Exclusion criteria Previous radiation therapy or potentially curative surgery. Other cancer (apart from skin cancer).
Population number of patients = 453.
Interventions After lymphangiogram (LAG) or staging lymphadenectomy (SL) patients were randomized between prophylactic radiation to the pelvic lymph nodes and prostatic bed vs. prostatic bed alone.
For those randomized to receive prophylactic pelvic lymph nodal irradiation, 45 Gy of megavoltage RT was delivered via multiple portals in 4.5 to 5 weeks, while all patients received a minimum 65 Gy (maximum 72 Gy) in 6.5 to 8 weeks to the prostatic bed.
Outcomes Treatment related morbidity. Morbidity was classified using a grading system (RTOG scale?), ranging from grade 1 (minor symptoms requiring no treatment) to grade 5 (fatal complications). Treatment related reactions occurring during the radiotherapy course were not labelled as complications unless they persisted beyond the first month after treatment completion or were classified as grade 3 or higher.
Follow up The minimum follow up was 2 years, median was 5 years.
Results Pelvic irradiation (WPRT), compared to prostate irradiation only, (PORT) was not associated with a significantly increased incidence of treatment related morbidity. Bowel morbidity rates (any grade, WPRT vs. PORT) : diarrhoea (14% vs. 9%), proctitis (10% vs. 11%), rectal/anal stricture (5% vs. 1%), rectal bleeding (10% vs. 13%) and rectal ulcer (2% vs. 0%).
Genitourinary morbidity rates (any grade, WPRT vs. PORT) : cystitis (11% vs. 12%), haematuria (6% vs. 11%), and urethral stricture (7% vs. 7%).
In general a significant effect of prostate radiation dose on morbidity was not observed. Total doses to the prostate of more than 70 Gy, however, were associated with an increased risk of rectal bleeding (p<0.01, Mantel-Haenszel test stratified by grade).
Numeric results
Comparison: Whole pelvic radiotherapy plus prostate boost versus prostate-only radiotherapy
WPRTPORT
GI toxicity (grade 3 or higher)13/2244/228
WPRTPORT
GU toxicity (grade 3 or higher)20/22423/228

From: Chapter 6 – Locally Advanced Prostate Cancer

Cover of Prostate Cancer
Prostate Cancer: Diagnosis and Treatment.
NICE Clinical Guidelines, No. 58.
National Collaborating Centre for Cancer (UK).
Copyright © 2008, National Collaborating Centre for Cancer.

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