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

Alliance for Clinical Trials in Oncology

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Procedure: surgery; Radiation: radiation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00023686

ACOSOG-Z0070

CDR0000068851 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 190 patients

Sex: Male

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

surgery

Experimental group

Description:

Patients undergo radical prostatectomy. Patients are followed every 6 months for 5 years and then annually thereafter.

Treatment:

Procedure: surgery

radiation

Experimental group

Description:

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.

Treatment:

Radiation: radiation