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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: surgery
* Radiation: radiation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: surgery<br>Patients undergo radical prostatectomy. Patients are followed every 6 months for 5 years and then annually thereafter. | Procedure: surgery<br> <br> |
| Experimental: radiation<br>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. | Radiation: radiation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease free survival |  | Up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer