Skip to content

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00023686
Enrollment
190
Registered
2003-01-27
Start date
2001-10-31
Completion date
2004-04-30
Last updated
2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer

Brief summary

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

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.

Interventions

PROCEDUREsurgery
RADIATIONradiation

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
No minimum to 75 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
overall survivalUp to 10 years

Secondary

MeasureTime frame
disease free survivalUp to 10 years

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026