This review concluded that immediate hormone therapy for nonmetastatic prostate cancer given as treatment adjuvant to radiotherapy or prostatectomy or as stand-alone treatment may result in longer than expected survival. Poor reporting of the review process and lack of a validity assessment made the reliability of the conclusion unclear.

To assess disease-free survival and overall survival in men with localised or locally advanced prostate cancer treated with immediate hormone therapy adjunctive to radiation therapy or radical prostatectomy or as stand-alone therapy.

MEDLINE, EMBASE, CANCERLIT, The Cochrane Library and Current Contents were searched from 1986 to September 2006. Search terms were reported. Abstracts from meetings of professional meetings and references of included studies were searched. The search was restricted to studies reported in English.

Randomised controlled trials (RCTs) and prospective or retrospective non-controlled trials of immediate hormone therapy adjunctive to radiation therapy or radical prostatectomy or as stand-alone therapy in men with localised or locally advanced prostate cancer were eligible for inclusion. Studies were required to report disease-free or overall survival and to have a median follow-up of at least two years. A minimum sample size of 50 patients was required. Studies were required to have begun patient recruitment after the start of prostate specific antigen (PSA) testing in 1986.

Trials of each type of eligible treatment regimen were included. Included studies used a range of luteinising hormone-releasing hormone agonists, antiandrogens and other treatments. Hormone therapy was given intramuscularly, subcutaneously or orally. Administration was prior to and/or during and/or following external beam radiation therapy or radical retropubic prostatectomy (where applicable). Patients with tumours that ranged from T1a to T4 (nodal metastases/nodal involvement) were included.

The authors did not state that they assessed validity.

Data were extracted on the outcomes of disease-free survival determined clinically or biochemically and overall survival. Annual probabilities of both outcomes were extracted at every year of follow-up. Where required, data were extrapolated from survival curves. Data on prognostic variables were extracted.

The authors did not state how many reviewers performed the data extraction.

Summary survival curves were produced for both disease-free and overall survival for each of the three types of treatment (adjuvant to radiation therapy, adjuvant to prostatectomy and stand-alone therapy). Curves were extrapolated to the latest time point at which more than 50% of studies reported follow-up.

Where there were sufficient data, subgroups based on the following factors were used to generate separate survival curves: definition of disease free survival (clinical versus biochemical); duration of hormone therapy (less than 24 months versus 24 months or longer); timing of hormone therapy (adjuvant versus neoadjuvant); intensity of hormone therapy (combined androgen blockade versus monotherapy); and patient risk groups (low versus intermediate versus high risk).

Thirty-five trials that included 37 treatment arms (n=11,105) were included in the review. Sample size ranged from 47 to 1,514. Median follow-up ranged from 2.6 to 7.8 years in treatment adjuvant to radiation therapy, from 2.8 to 10.4 years in treatment adjuvant to prostatectomy and from 3.9 to 10.4 years for stand-alone treatment.

Treatment adjunctive to radiation therapy (16 trials including 10 RCTs): Median disease-free survival for men given immediate hormone therapy was 5.4 years and the five-year disease-free survival rate was 52% (14 trials, n=5,852). Median overall survival was over seven years with a five-year survival rate of 82% (11 trials, n=4,688).

Treatment adjunctive to prostatectomy (11 trials including eight RCTs): Median disease-free survival for men given immediate hormone therapy was over six years, with a five-year disease-free survival rate of 64% (10 trials, n=1,733). Median overall survival was over seven years with a five-year survival rate of 90% (six trials, n=607).

Stand-alone therapy (10 trials including seven RCTs): Median disease-free survival for men given immediate hormone therapy was 6.0 years, with a five year disease free survival rate of 57% (four trials, n=781). Median overall survival was over seven years, with a five-year survival rate of 70% (10 trials, n=3,233).

Survival in men with nonmetastatic prostate cancer treated with hormone therapy may be longer than previously estimated.

The review question and the inclusion criteria were clear. The authors searched a number of relevant databases and other sources, which reduced the chances that relevant studies were omitted from the review. The restriction of the review to studies reported in English may have led to the introduction of language bias. The authors did not report that they used methods designed to reduce reviewer bias and error at any stage of the review process. The authors did not report that they carried out an assessment of study validity, which made it difficult to determine the reliability of the evidence presented. The decision to perform a statistical synthesis grouped by the other treatment given appeared reasonable. There was a degree of clinical and methodological heterogeneity between studies and this was partially explored; this may have reduced the informativeness of the pooled estimate. The failure to consider the results of the other interventions assessed in the controlled trials limited the usefulness of the conclusions that could be drawn from included evidence.

The authors' conclusions followed from the results of the review, but poor reporting of the review process and the lack of a validity assessment made the reliability of the conclusions unclear.

Practice: The authors stated that decisions on which hormonal regimen to select and whether such treatment should be combined with local therapy should be based on clinical and tumour characteristics and on patient wishes.

Research: The authors stated that further meta-analyses could be used to compare early hormone therapy with delayed therapy and continuous therapy with intermittent therapy.

Not stated.

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.