Prostate Cancer Health Center

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Bicalutamide has not been shown to improve OS in patients with localized or locally advanced prostate cancer. The Early Prostate Cancer program is a large, randomized, placebo-controlled, international trial that compared bicalutamide (150 mg orally per day) plus standard care (radical prostatectomy, radiation therapy, or watchful waiting, depending on local custom) with standard care alone for men with nonmetastatic localized or locally advanced prostate cancer (T1-2, N0, NX; T3-4, any N; or any T, N+).[9] Less than 2% of the 8,113 men had known node disease. At a median follow-up of 7.4 years, there was no difference in OS between the bicalutamide and placebo groups (about 76% in both arms [HR = 0.99; 95% CI, 0.91-1.09; P = .89]).[9][Level of evidence: 1iA]

Immediate hormone therapy with goserelin or orchiectomy has also been compared with deferred hormone therapy for clinical disease progression in a randomized trial (EORTC-30846) of men with regional lymph node involvement but no clinical metastases (any T, N+, M0).[10] None of the 234 men received prostatectomy or prostatic radiation therapy. After a median follow-up of 8.7 years, the HR for OS in the deferred versus immediate hormone therapy arms was 1.23 (95% CI, 0.88-1.71). No statistically significant difference in OS between deferred and immediate hormone therapy was found, but the trial was underpowered to detect small or modest differences.[10][Level of evidence: 1iiA]

Patients with locally advanced nonmetastatic disease (T2-T4, N0-N1, M0) are at risk for developing bone metastases, and bisphosphonates are being studied as a strategy to decrease this risk. However, a placebo-controlled randomized trial (MRC-PR04) of a 5-year regimen of the first-generation bisphosphonate clodronate in high oral doses (2,080 mg per day) had no favorable impact on either time to symptomatic bone metastasis or survival.[11][Level of evidence: 1iA]

Hormonal treatment is the mainstay of therapy for distant metastatic (stage D2) prostate cancer. Cure is rarely, if ever, possible, but striking subjective or objective responses to treatment occur in most patients. Initial results from a randomized study of immediate hormonal treatment (e.g., orchiectomy or LHRH analog) versus deferred treatment (e.g., watchful waiting with hormonal therapy at progression) in men with locally advanced or asymptomatic metastatic prostate cancer showed better OS and prostate cancer-specific survival with the immediate treatment. The incidence of pathologic fractures, spinal cord compression, and ureteric obstruction were also lower in the immediate treatment arm.[12][Level of evidence: 1iiA] In another trial, 197 men with stage III or stage IV prostate cancer were randomly assigned to receive bilateral orchiectomy at diagnosis or at the time of symptomatic progression (or at the time of new metastases that were deemed likely to cause symptoms). Over a 12-year period of follow-up, no statistically significant difference was observed in OS.[13][Level of evidence: 1iiA]