Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer

Radiation Therapy Oncology Group

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Radiation: External Beam Radiation Therapy; Radiation: Brachytherapy (125/145); Radiation: Brachytherapy (100/110)

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT00063882

NCI-2009-01091 (Registry Identifier)

CDR0000288823

RTOG 0232

Details and patient eligibility

About

RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells. Interstitial brachytherapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Combining interstitial brachytherapy with external-beam radiation therapy may kill more tumor cells. It is not yet known whether interstitial brachytherapy is more effective with or without external-beam radiation therapy in treating prostate cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of interstitial brachytherapy with or without external-beam radiation therapy in treating patients who have prostate cancer.

Full description

OBJECTIVES:

• Compare the 5-year freedom from progression in patients with intermediate-risk prostate cancer treated with interstitial brachytherapy with or without external beam radiotherapy (EBRT).
• Compare biochemical (i.e., prostate-specific antigen) failure, biochemical failure by the Phoenix definition, disease-specific survival, local progression, and distant metastases in patients treated with these regimens.
• Compare morbidity and quality of life of patients treated with these regimens.
• Determine the feasibility of collecting Medicare data in a large Radiation Therapy Oncology Group (RTOG) prostate cancer clinical trial for cost effectiveness and cost utility analysis of combined treatment with interstitial brachytherapy and EBRT.
• Prospectively collect diagnostic biopsy samples from these patients for future biomarker analyses.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T1c vs T2a or T2b), Gleason score (≤ 6 vs 7), prostate-specific antigen (< 10 ng/mL vs 10-20 ng/mL), and prior neoadjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo external beam radiotherapy 5 days a week for 5 weeks. Within 2-4 weeks of radiotherapy, patients undergo interstitial brachytherapy with iodine I 125 or palladium Pd 103 seeds.
• Arm II: Patients undergo interstitial brachytherapy only, as in arm I. Quality of life is assessed at baseline, at 4, 12, and 24 months, and then annually for 3 years.

After completion of study treatment, patients are followed at 3-5 weeks, at 4, 6, 9, and 12 months, every 6 months for 4 years, and then annually thereafter.

Enrollment: 588 patients

Sex: Male

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate

  • T1c-T2b, N0, M0

• Intermediate-risk disease, as defined by 1 of the following:

  • Gleason score < 7 AND prostate-specific antigen (PSA) 10-20 ng/mL
  • Gleason score 7 AND PSA < 10 ng/mL

• No evidence of distant metastases

• Prostate volume ≤ 60 cc by transrectal ultrasonography

• American Urological Association voiding symptom score no greater than 15 (alpha blockers allowed)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Patients must use effective contraception
• No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ at any other site
• No major medical or psychiatric illness that would preclude study therapy
• No hip prosthesis

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy

Endocrine therapy

• Prior neoadjuvant hormonal therapy allowed provided the following are true:

  • Therapy was initiated within 2-6 months of study enrollment
  • Therapy was no more than 6 months in duration
  • Use of 5-alpha reductase inhibitors (e.g., finasteride) is discontinued before registration

• No concurrent hormonal therapy

Radiotherapy

• No prior pelvic radiotherapy

Surgery

• No prior radical surgery for prostate cancer
• No prior transurethral resection of the prostate
• No prior cryosurgery

Other

• No prior transurethral needle ablation of the prostate
• No prior transurethral microwave thermotherapy of the prostate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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588 participants in 2 patient groups

EBRT + Brachytherapy

Experimental group

Description:

External beam radiation therapy (EBRT) and transperineal interstitial permanent brachytherapy (100/110)

Treatment:

Radiation: Brachytherapy (100/110)

Radiation: External Beam Radiation Therapy

Brachytherapy Only

Active Comparator group

Description:

Transperineal interstitial permanent brachytherapy (125/145)

Treatment:

Radiation: Brachytherapy (125/145)