Surgery Versus Internal Radiation in Treating Patients With Stage II Prostate Cancer

A Randomized Trial of Radical Prostatectomy Versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer

RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether surgery is more effective than internal radiation in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of surgery with that of internal radiation in treating patients who have stage II prostate cancer.

OBJECTIVES:

• Compare overall survival in patients with stage II prostate cancer treated with radical prostatectomy vs brachytherapy.
• Compare metastasis-free survival and probability of survival without symptoms of patients treated with these regimens.
• Compare the side effects of these treatment regimens in these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

• Arm I: Patients undergo radical prostatectomy.
• Arm II: Patients undergo brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds Patients are followed every 6 months for 5 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,980 patients (990 per treatment arm) will be accrued for this study within 5.5 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate within the past 120 days

  • T1c-T2a, N0, M0

• No bilateral disease

• Prostate-specific antigen (PSA) no greater than 10 ng/mL

  • In patients with prior neoadjuvant hormonal therapy (NHT), PSA must be less than 10 ng/mL prior to therapy

• Gleason score no greater than 6

• Prostate gland less than 60 cc on transrectal ultrasound or with minimal pubic arch interference OR

• Prostate gland 60 cc or greater prior to NHT allowed if prostate size has been reduced to less than 60 cc by NHT

PATIENT CHARACTERISTICS:

Age:

• 75 and under

Performance status:

• ECOG 0-2 OR
• Zubrod 0-2

Renal:

• Creatinine no greater than 3 mg/dL

Cardiovascular:

• No significant cardiovascular disease
• No New York Heart Association class III or IV heart disease

Other:

• No other malignancy within the past 5 years except effectively treated basal cell or squamous cell skin cancer or other malignancy at low risk for recurrence
• No other condition that would preclude study

PRIOR CONCURRENT THERAPY:

Endocrine therapy:

• See Disease Characteristics

• At least 90 days since prior NHT

  • Duration of therapy no greater than 120 days

• No concurrent NHT

Radiotherapy:

• No prior radiotherapy to pelvis

Surgery:

• No prior surgery for prostate cancer or benign disease, including:

  • Transurethral resection of the prostate
  • Transurethral resection of the bladder neck
  • Cryotherapy
  • Laser ablation
  • Microwave therapy