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Interstitial Brachytherapy Wi...

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

Last Updated: 2023-03-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

588 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2022-12-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EBRT + Brachytherapy

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

Group Type EXPERIMENTAL

Brachytherapy (100/110)

Intervention Type RADIATION

100 Gy Palladium-103 (P-102) or 110 Gy Iodine-125 (I-125) seeds within 2-4 weeks of completion of external beam radiotherapy.

External Beam Radiation Therapy

Intervention Type RADIATION

Total dose of 45 Gy to the prostate and seminal vesicles as a daily dose of 1.8 Gy given 5 times per week. The prescribed dose is defined at the International Commission of Radiation Units and Measurements (ICRU) reference point. Both 3D-conformal radiation therapy (3DCRT) and intensity modulated radiation therapy (IMRT) are permitted.

Brachytherapy Only

Transperineal interstitial permanent brachytherapy (125/145)

Group Type ACTIVE_COMPARATOR

Brachytherapy (125/145)

Intervention Type RADIATION

125 Gy Palladium-103 (P-103) or 145 Gy Iodine-125 (I-125) seeds within 4 weeks of study entry.

Interventions

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Brachytherapy (100/110)

100 Gy Palladium-103 (P-102) or 110 Gy Iodine-125 (I-125) seeds within 2-4 weeks of completion of external beam radiotherapy.

Intervention Type RADIATION

Brachytherapy (125/145)

125 Gy Palladium-103 (P-103) or 145 Gy Iodine-125 (I-125) seeds within 4 weeks of study entry.

Intervention Type RADIATION

External Beam Radiation Therapy

Intervention Type RADIATION

Other Intervention Names

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EBRT

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bradley R. Prestidge, MD

Role: PRINCIPAL_INVESTIGATOR

Bon Secours Cancer Institute

Locations

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Arizona Oncology Services Foundation

Phoenix, Arizona, United States

Site Status

Auburn Radiation Oncology

Auburn, California, United States

Site Status

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, United States

Site Status

Peninsula Medical Center

Burlingame, California, United States

Site Status

Radiation Oncology Centers - Cameron Park

Cameron Park, California, United States

Site Status

Mercy Cancer Center at Mercy San Juan Medical Center

Carmichael, California, United States

Site Status

East Bay Radiation Oncology Center

Castro Valley, California, United States

Site Status

Valley Medical Oncology Consultants - Castro Valley

Castro Valley, California, United States

Site Status

Valley Medical Oncology

Fremont, California, United States

Site Status

California Cancer Center - Woodward Park Office

Fresno, California, United States

Site Status

Kaiser Permanente Medical Center - Hayward

Hayward, California, United States

Site Status

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status

El Camino Hospital Cancer Center

Mountain View, California, United States

Site Status