Radical Retropubic Prostatectomy Versus Conventional External Beam Radiotherapy for Clinically Localized Prostate Cancer

Radical Retropubic Prostatectomy Versus Conventional External Beam Radiotherapy for Clinically Localized Prostate Cancer

The purpose of this study is to evaluate the effectiveness of the two most established primary treatments for patients with clinically localized prostate cancer: radical retropubic prostatectomy, and external-beam radiotherapy. The primary aim is assessing biochemical disease-free survival, overall survival, and prostate cancer-specific survival. As secondary objectives quality of Life impact of treatments' side effects will be also assessed.

Eligible patients had clinically localized (clinical TNM classification T1 or T2), biopsy-proven adenocarcinoma of the prostate and were randomly treated with RRP or EBRT. Exclusion criteria included prior treatment for prostate cancer, the presence of metastatic disease on imaging studies, the receipt of neoadjuvant androgen ablation before registration, and an inability to read or understand Italian language. The institutional review boards of every participating centre approved the study design. Every patient enrolled signed an informed-consent form approved by the institutional review boards. Clinical information collected from the medical record included pre-treatment serum prostate-specific antigen (PSA) level, clinical T classification, and biopsy Gleason score. Follow-up assessments were completed before treatment and every 3 months after treatment. Subjects who sought primary treatment elsewhere or did not return follow-up questionnaires beyond the initial assessment were excluded from this analysis.

Inclusion Criteria:

• Age 75 years or younger
• Diagnosis of prostate cancer, as verified by cytologic or histologic examination the tumor is well differentiated to moderately well differentiated
• Untreated, clinically localized prostate cancer, with a tumor stage of T1, or T2
• Prostate specific antigen (PSA) level of ≤10 ng/ml
• Bone scan with no abnormalities
• Health status that would permit radical prostatectomy
• Life expectancy of more than 10 years.

Exclusion Criteria:

• PSA >10 ng/ml
• Bone scan consistent with metastatic disease
• Other evidence that cancer of the prostate is not clinically localized
• Life expectancy less than 10 years
• Serum creatinine greater than 3 mg/dl
• Myocardial infarction within last 6 months
• Unstable angina Class III or IV
• Severe pulmonary disease
• Liver failure
• Severe dementia
• Debilitating illness Malignancies, except for nonmelanomatous skin cancer, in the last 5 years.