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ADT in their observational management groups, such primary studies would not have met the
primary study inclusion criteria for this report.
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One AHRQ evidence report included two RCTs comparing WW with RP: the Scandinavian
Prostate Cancer Group Study 4 (SPCG-4), 210 and the Veterans Administration Cooperative
Urological Research Group (VACURG) trial. 211 A recent (2010) Cochrane Report on the same
212
topic did not identify any additional studies; however, we identified the latest update of the
SPCG-4 trial results 213,214 (discussed in the primary study section below). In SPCG-4, 695
patients were enrolled between 1989 and 1999, and randomized to either watchful waiting (WW)
or radical prostatectomy (RP); they were followed for a median of 8.2 years. When compared
with patients on WW, patients who had RP had significantly lower mortality (RR 0.74; 95
percent CI 0.56, 0.99; P = 0.04), disease-specific mortality (RR 0.56; 95 percent CI 0.36, 0.88;
P = 0.01), and distant metastases (RR 0.60; 95 percent CI 0.42, 0.86; P = 0.04). 210 The VACURG
trial followed 142 patients for a median of 23 years, and found no difference in mortality
between WW and RP groups. 211
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Additionally, the AHRQ evidence report on localized prostate cancer treatment considered
the results of two randomized trials reporting on QoL and self-reported functional status. 215,216
One included study was an ancillary investigation from the SPCG-4. 215 The study found that
self-reported erectile dysfunction and urinary leakage were more common in the RP group,
whereas urinary obstruction was more common in the WW group. Bowel function, prevalence of
anxiety, prevalence of depression, well-being, and the subjective QoL were similar in the two
groups. 215 The second study was based on a randomized trial comparing RT with deferred
treatment 216 and demonstrated that patients in the RT group experienced a decrease in QoL due
to the development of hematuria, incontinence, mucus, and having to plan daily activities in
216
response to intestinal problems.
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Another AHRQ report that compared RT and no treatment evaluated one prospective cohort
217
study and eight 209,218-224 retrospective cohort studies. The included prospective cohort study
reported no difference in sexual function between brachytherapy (BT) and no treatment, but
significantly worse sexual function between external beam radiation therapy (EBRT) and no
treatment. 217 Of the four retrospective cohort studies that compared disease-specific survival
between radiation therapy and no treatment, one found significantly better disease-specific
survival in men treated with BT. 219 Three studies reported gastrointestinal or genitourinary
toxicity outcomes and found no difference between BT or EBRT and no treatment, but one study
found a higher rate of receiving treatment for urethral stricture in patients treated with combined
EBRT and BT, compared with those with no treatment. 218 One study reported significantly
higher rates of second primary cancer in patients treated with EBRT compared with those with
no treatment. 220

Findings from Primary Studies
To address Key Question 4, we searched for studies that compared observational
management strategies with immediate definitive treatment. As discussed above, our searches
did not identify any studies comparing patients managed with AS versus immediate active
treatment with curative intent. Here we summarize findings from reviewed studies where the
observational management strategy mostly resembled WW. We included only multicenter
studies that enrolled men with localized prostate cancer, and reported age-adjusted effect sizes.
Characteristics of the 12 eligible studies reporting on clinical outcomes are shown in Appendix
Table C4.1. Two RCTs (in 3 publications 213,214,225 ) three prospective cohort studies, 226-228 and ten

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