(Asbell et al. 1998)
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 = 449, age range 46 to 47 years, mean age = 68 years.
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 65 Gy in 6.5 to 8 weeks to the prostatic bed.
Outcomes Overall survival, recurrence free survival, distant-metastasis free survival and no-evidence-of-disease (NED) survival. Local or regional failure was defined as either progression of measurable disease at any time, or histological verification of tumour 2 years after radiotherapy. Progression of tumour was defined as at least a 25% increase in the palpable tumour mass dimensions.
Morbidity outcomes for this trial are reported in Pilepich et al (1983, 1984, and 1987).
Follow up Follow-up was a median of 12 years and a maximum of 16 years.
Results 117 patients had had staging lymphadenectomy (SL), the remaining 332 had staging lymphangiogram (LAG).
There was no significant difference in survival, NED survival, local control or time to distant metastases, whether treatment was administered to the prostate or prostate and pelvic lymph nodes. Median survival was 10.7 years for the prostate-only group and 10.5 years for the pelvis+prostate group. 12 year survival was 43% and 38% for the two groups respectively [p not significant using the log rank test].
The SL group had greater 12-year overall survival than the LAG group (48% vs. 38%, p = 0.02, log rank test), the LAG group, however, had a greater proportion of older patients
Numeric results
General comments Pre PSA era study. Multivariate analysis was not done, but would have been useful for the SL vs. LAG comparison. The authors comment that the accuracy of LAG for staging is questionable, the observed survival difference may be due to this inaccuracy.

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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