AzTrials
AzTrials

Prostate CancerPhase 3NCT00063882

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

A Phase 3 study testing Brachytherapy (100/110), Brachytherapy (125/145) and External Beam Radiation Therapy in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 170 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 120 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Brachytherapy (100/110), Brachytherapy (125/145) and External Beam Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
588 participants
Where
170 sitesin 2 countries
Study dates
Jun 2003to 22 Dec 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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 locations and contacts

170 sites in 2 countries.

170 sites in 2 countries

United States168 sites

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • Radiation Oncology Center

    Alliance, Ohio, 44601

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Auburn Radiation Oncology

    Auburn, California, 95603

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • St. Agnes Hospital Cancer Center

    Baltimore, Maryland, 21229

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • Alta Bates Summit Comprehensive Cancer Center

    Berkeley, California, 94704

  • Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Peninsula Medical Center

    Burlingame, California, 94010

  • Radiation Oncology Centers - Cameron Park

    Cameron Park, California, 95682

  • Sands Cancer Center

    Canandiaqua, New York, 14424

  • Mercy Cancer Center at Mercy San Juan Medical Center

    Carmichael, California, 95608

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants - Castro Valley

    Castro Valley, California, 94546

  • Sandra L. Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters

    City of Saint Peters, Missouri, 63376

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1240

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Medical Center Cancer Care

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Geisinger Cancer Institute at Geisinger Health

    Danville, Pennsylvania, 17822-0001

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Community Cancer Center

    Elyria, Ohio, 44035

  • Hematology Oncology Center

    Elyria, Ohio, 44035

  • St. Francis Hospital

    Federal Way, Washington, 98003

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Fredericksburg Oncology, Incorporated

    Fredericksburg, Virginia, 22401

  • Valley Medical Oncology

    Fremont, California, 94538

  • California Cancer Center - Woodward Park Office

    Fresno, California, 93720

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Kaiser Permanente Medical Center - Hayward

    Hayward, California, 94545

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Cape Cod Hospital

    Hyannis, Massachusetts, 02601

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center

    Jupiter, Florida, 33458

  • Saint Luke's Cancer Institute at Saint Luke's Hospital

    Kansas City, Missouri, 64111

  • St. Joseph Medical Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Parvin Radiation Oncology

    Kansas City, Missouri, 64116

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Kingsbury Center for Cancer Care at Cheshire Medical Center

    Keene, New Hampshire, 03431

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • CCOP - Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Nevada Cancer Institute

    Las Vegas, Nevada, 89135

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Liberty Hospital

    Liberty, Missouri, 64068

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Shields Radiation Oncology Center - Mansfield

    Mansfield, Massachusetts, 02048

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

    Marlton, New Jersey, 08053

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Northwest Ohio Oncology Center

    Maumee, Ohio, 43537-1839

  • Columbia Saint Mary's Hospital - Ozaukee

    Mequon, Wisconsin, 53097

  • CCOP - Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Columbia-Saint Mary's Cancer Care Center

    Milwaukee, Wisconsin, 53211

  • Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Coleman Radiation Oncology Center at Carter General Hospital

    Morehead City, North Carolina, 28557

  • El Camino Hospital Cancer Center

    Mountain View, California, 94040

  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

    Murray, Utah, 84157

  • CarolinaEast Cancer Care

    New Bern, North Carolina, 28560

  • Hospital of Saint Raphael

    New Haven, Connecticut, 06511

  • Beth Israel Medical Center - Petrie Division

    New York, New York, 10003-3803

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19713

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

  • Sutter Health - Western Division Cancer Research Group

    Novato, California, 94945

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Breast Surgeons, Incorporated

    Oakland, California, 94609

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Larry G Strieff MD Medical Corporation

    Oakland, California, 94609

  • Tom K Lee, Incorporated

    Oakland, California, 94609

  • Kaiser Permanente - Division of Research - Oakland

    Oakland, California, 94611

  • Kaiser Permanente Medical Center - Oakland

    Oakland, California, 94611

  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Arizona Oncology Services Foundation

    Phoenix, Arizona, 85013

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • CCOP - Kansas City

    Prairie Village, Kansas, 66208

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Good Samaritan Cancer Center

    Puyallup, Washington, 98372

  • South Suburban Oncology Center

    Quincy, Massachusetts, 02169

  • All Saints Cancer Center at Wheaton Franciscan Healthcare

    Racine, Wisconsin, 53405

  • Kaiser Permanente Medical Center - Rancho Cordova

    Rancho Cordova, California, 95670

  • McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

    Reading, Pennsylvania, 19612-6052

  • Kaiser Permanente Medical Center - Redwood City

    Redwood City, California, 94063

  • Renown Institute for Cancer at Renown Regional Medical Center

    Reno, Nevada, 89502

  • Kaiser Permanente Medical Center - Richmond

    Richmond, California, 94801

  • Veterans Affairs Medical Center - Richmond

    Richmond, Virginia, 23249

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • University Radiation Oncology at Parkridge Hospital

    Rochester, New York, 14626

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Rohnert Park Cancer Center

    Rohnert Park, California, 94928

  • Kaiser Permanente Medical Center - Roseville

    Roseville, California, 95661

  • Radiation Oncology Center - Roseville

    Roseville, California, 95661

  • Radiological Associates of Sacramento Medical Group, Incorporated

    Sacramento, California, 95815

  • Mercy General Hospital

    Sacramento, California, 95819

  • South Sacramento Cancer Center

    Sacramento, California, 95823

  • South Sacramento Kaiser-Permanente Medical Center

    Sacramento, California, 95823

  • Kaiser Permanente Medical Center - Sacramento

    Sacramento, California, 95825

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • Norris Cotton Cancer Center - North

    Saint Johnsbury, Vermont, 05819

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Saint Joseph Oncology, Incorporated

    Saint Joseph, Missouri, 64507

  • Cancer Care Center, Incorporated

    Salem, Ohio, 44460

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Kaiser Permanente Medical Center - San Francisco Geary Campus

    San Francisco, California, 94115

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • California Pacific Medical Center - California Campus

    San Francisco, California, 94118

  • Kaiser Permanente Medical Center - Santa Teresa

    San Jose, California, 95119

  • Kaiser Foundation Hospital - San Rafael

    San Rafael, California, 94903

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • Kaiser Permanente Medical Center - Santa Clara Kiely Campus

    Santa Clara, California, 95051

  • Study site

    Santa Clara, California, 95051

  • Kaiser Permanente Medical Center - Santa Rosa

    Santa Rosa, California, 95403

  • Kaiser Permanente Medical Center - South San Francisco

    South San Francisco, California, 94080

  • Cancer Institute at St. John's Hospital

    Springfield, Illinois, 62702

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • Barnes-Jewish West County Hospital

    St Louis, Missouri, 63141

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • Kaiser Permanente Medical Facility - Stockton

    Stockton, California, 95210

  • South Atlantic Radiation Oncology, LLC

    Supply, North Carolina, 28462

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • Franciscan Cancer Center at St. Joseph Medical Center

    Tacoma, Washington, 98405-3004

  • CCOP - Northwest

    Tacoma, Washington, 98405

  • MultiCare Regional Cancer Center at Tacoma General Hospital

    Tacoma, Washington, 98405

  • Mercy Hospital of Tiffin

    Tiffin, Ohio, 44883

  • Toledo Hospital

    Toledo, Ohio, 43606

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • Medical University of Ohio Cancer Center

    Toledo, Ohio, 43614

  • CCOP - Toledo Community Hospital

    Toledo, Ohio, 43617

  • St. Anne Mercy Hospital

    Toledo, Ohio, 43623

  • Toledo Clinic, Incorporated - Main Clinic

    Toledo, Ohio, 43623

  • Solano Radiation Oncology Center

    Vacaville, California, 95687

  • Sutter Solano Medical Center

    Vallejo, California, 94589

  • Fox Chase Virtua Health Cancer Program at Virtua West Jersey

    Voorhees Township, New Jersey, 08043

  • Kaiser Permanente Medical Center - Walnut Creek

    Walnut Creek, California, 94596

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

  • West Allis Memorial Hospital

    West Allis, Wisconsin, 53227

  • Mount Carmel St. Ann's Cancer Center

    Westerville, Ohio, 43081

  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania, 18711

  • Coastal Carolina Radiation Oncology Center

    Wilmington, North Carolina, 28401

  • Winchester Hospital Radiation Oncology Center

    Winchester, Massachusetts, 01890

  • Cancer Treatment Center

    Wooster, Ohio, 44691

  • York Cancer Center at Apple Hill Medical Center

    York, Pennsylvania, 17405

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

Canada2 sites

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy With Brachytherapy Alone for Selected Patients With Intermediate Risk Prostatic Carcinoma

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.

Read the detailed 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.

Conditions
Prostate Cancer
Being tested
Brachytherapy (100/110), Brachytherapy (125/145), External Beam Radiation Therapy
Keywords
stage IIB prostate cancer, stage IIA prostate cancer, adenocarcinoma of the prostate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brachytherapy (100/110)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.

  • Brachytherapy (125/145)Radiation

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

  • External Beam Radiation TherapyRadiation

    Also called EBRT

    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.

Study groups in NCT00063882
Study groupRoleWhat they receive
EBRT + BrachytherapyExperimentalExternal beam radiation therapy (EBRT) and transperineal interstitial permanent brachytherapy (100/110)
Receives: Radiation: Brachytherapy (100/110); Radiation: External Beam Radiation Therapy
Brachytherapy OnlyActive comparatorTransperineal interstitial permanent brachytherapy (125/145)
Receives: Radiation: Brachytherapy (125/145)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 5-Year Freedom From Progression Rate

    A Freedom from Progression (FFP) failure includes biochemical failure, local failure, distant failure, or death due to any cause. Patients who are failure free with less than 5 years of follow-up or who receive any secondary salvage therapy are censored. Freedom from Progression rates are estimated using the Kaplan-Meier method.

    Measured: From randomization to 5 years

Secondary outcomes (14)

  1. Biochemical Failure Rate (Protocol Definition)

    Biochemical failure is defined as having 3 consecutive rises of post-treatment PSA or starting hormones after one or more elevations in post-treatment PSA but before 3 consecutive elevations are documented. The sum of the 3 consecutive rises must exceed 1 ng/mL above the nadir. If 3 consecutive PSA rises occur during the first 24 months followed by a subsequent non-hormonal induced PSA decrease, patients will not be considered PSA failures. Three consecutive rises with any of the 3 PSA values occurring more than 24 months after the implant procedure will constitute a failure. Time to biochemical is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Five year rates are reported.

    Measured: From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.

  2. Biochemical Failure (Phoenix Definition)

    Biochemical Failure is defined as an increase of 2 ng/ml or more in PSA over the nadir PSA after 24 months from the start of treatment or the start of salvage hormones. Time to biochemical is defined as time from randomization to the date of first biochemical failure, last known follow-up (censored), or death without biochemical failure (competing risk). Biochemical failure rates are estimated using the cumulative incidence method. Five year rates are reported.

    Measured: From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.Maximum follow-up at time of analysis was 13.9 years.

  3. Prostate Cancer Death

    Prostate cancer death is defined as death due to prostate cancer or complications of treatment or death associated with any of the following: 1) further clinical tumor progression occurring after initiation of salvage androgen suppression therapy; 2) a rise that exceeds 1.0 ng/ml in the serum PSA level on at least two consecutive occasions that occurs during or after salvage androgen suppression therapy; and 3) disease progression in the absence of any anti-tumor therapy. Time to prostate cancer death is defined as time from randomization to the date of prostate cancer death, last known follow-up (censored), or death without prostate cancer (competing risk). Prostate cancer death rates are estimated using the cumulative incidence method. Five year rates are reported.

    Measured: From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.

  4. Local Failure

    Failure is defined as progression (increase in palpable abnormality) at any time, failure of regression of the palpable tumor by two years, and redevelopment of a palpable abnormality after complete disappearance of previous abnormalities. Histologic criteria for local failure are presence of prostatic carcinoma upon biopsy and positive biopsy of the palpably normal prostate more than two years after the start of treatment. Time to local failure is defined as time from randomization to the date of first local failure, last known follow-up (censored), or death without local failure (competing risk). Local failure rates are estimated using the cumulative incidence method. Five year rates are reported.

    Measured: From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.

  5. Distant Metastases

    Failure is defined as the appearance of any distant metastases. Time to distant metastases is defined as time from randomization to the date of first distant metastases, last known follow-up (censored), or death without distant metastases (competing risk). Distant metastases rates are estimated using the cumulative incidence method. Five year rates are reported.

    Measured: From randomization to last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. Maximum follow-up at time of analysis was 13.9 years.

  6. Overall Survival

    Failure is defined as death due to any cause. Overall survival time is defined as time from randomization to the date of death or last known follow-up (censored). Survival rates are estimated using the Kaplan-Meier method. Five year rates are reported.

    Measured: From randomization to last follow-up. Analysis occurs after all patients had been on study for at least 5 years. Maximum follow-up at time of analysis was 13.9 years.

  7. Percentage of Patients With Acute Grade 2+ and Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall]

    Acute toxicities are scored according to NCI Common Toxicity Criteria (CTC) version 2.0 and will be defined as the worst severity of the toxicity occurring ≤ 180 days from start of radiation. The CTC v 2.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to based.

    Measured: Zero to 180 days from the start of radiation

  8. Time to Late Grade 3+ Toxicities [Genitourinary (GU), Gastrointestinal (GI), and Overall]

    Late toxicities are scored according to the Radiation Therapy Oncology Group (RTOG)/European Organisation for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Scheme and will be defined as the worst severity of the toxicity occurring > 180 days from radiation start. Grade 3+ GU/GI and overall were analyzed. RTOG/EORTC Late Radiation Morbidity Scoring Scheme assigns Grades 1 through 5 with unique clinical descriptions of severity for each toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity. Time to late grade 3+ toxicity is defined as time from randomization to the date of first late grade 3+ toxicity, last known follow-up (censored), or death without late grade 3+ toxicity (competing risk). Late grade 3+ toxicity rates are estimated using the cumulative incidence method. Five year rates are reported.

    Measured: From 181 days after the start of radiation to last follow-up. Maximum follow-up at time of analysis was 13.9 years.

  9. Change in Expanded Prostate Cancer Index Composite (EPIC) From Baseline to 4 Months

    The EPIC form is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal function). The urinary domain summary score can be separated into 2 distinct subscales: urinary incontinence and urinary irritative. Hormonal domain was excluded as concurrent use of hormones was exclusionary and prior neoadjuvant hormone use was low. Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. The change score was calculated as the value at 4 months minus the value at baseline. A negative change reflects a decline at 4 months and a positive change reflects an improvement at 4 months.

    Measured: Baseline and 4 months after start of radiation

  10. Change in Expanded Prostate Cancer Index Composite (EPIC) From Baseline to 24 Months

    The EPIC form is a 50-item, validated tool to assess disease-specific aspects of prostate cancer and its therapies and comprises of four summary domains (bowel, urinary, sexual, and hormonal function). The urinary domain summary score can be separated into 2 distinct subscales: urinary incontinence and urinary irritative. Hormonal domain was excluded as concurrent use of hormones was exclusionary and prior neoadjuvant hormone use was low. Response options for each EPIC item form a Likert scale and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health related quality of life. The change score was calculated as the value at 24 months minus the value at baseline. A negative change reflects a decline at 24 months and a positive change reflects an improvement at 24 months.

    Measured: Baseline and 24 months after start of radiation

  11. Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 4 Months

    The AUA-SI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as follow-up timepoint score - baseline score such that a negative change reflects an improvement at the follow-up timepoint and a positive change reflects a decline at the follow-up timepoint.

    Measured: Baseline and 4 months after start of radiation

  12. Change in Total American Urological Association Symptom Index (AUA-SI) Score From Baseline to 24 Months

    The AUA-SI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as follow-up timepoint score - baseline score such that a negative change reflects an improvement at the follow-up timepoint and a positive change reflects a decline at the follow-up timepoint.

    Measured: Baseline and 24 months after start of radiation

  13. Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 4 Months

    The EQ-5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The change score was calculated as the value at the follow-up timepoint minus the value at baseline. A negative change reflects a decline at the follow-up timepoint and a positive change reflects an improvement at the follow-up timepoint.

    Measured: Baseline and 4 months after start of radiation

  14. Change in European Quality of Life-5 Domains (EQ-5D) From Baseline to 24 Months

    The EQ5D is a 2-part self-assessment questionnaire. First part is 5 items (mobility, self care, usual activities, pain/discomfort, anxiety/depression) each with 3 problem levels (1-none, 2-moderate, 3-extreme). The 5-item index score is transformed into a utility score between 0 (worst health state) and 1 (best health state). The 2nd part is a visual analogue scale (VAS) valuing current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The change score was calculated as the value at the follow-up timepoint minus the value at baseline. A negative change reflects a decline at the follow-up timepoint and a positive change reflects an improvement at the follow-up timepoint.

    Measured: Baseline and 24 months after start of radiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2003 (estimated)
  2. Study startJun 2003
  3. Primary completionMay 2017
  4. Study completion22 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
588 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00063882
Sponsor's protocol ID
RTOG 0232
Other IDs
CDR0000288823, NCI-2009-01091
Status last verified
Dec 2022
First submitted
8 Jul 2003
Last updated
5 Mar 2026
Data monitoring committee
Yes

Publications

  • Michalski JM, Winter KA, Prestidge BR, Sanda MG, Amin M, Bice WS, Gay HA, Ibbott GS, Crook JM, Catton CN, Raben A, Bosch W, Beyer DC, Frank SJ, Papagikos MA, Rosenthal SA, Barthold HJ, Roach M 3rd, Moughan J, Sandler HM. Effect of Brachytherapy With External Beam Radiation Therapy Versus Brachytherapy Alone for Intermediate-Risk Prostate Cancer: NRG Oncology RTOG 0232 Randomized Clinical Trial. J Clin Oncol. 2023 Aug 20;41(24):4035-4044. doi: 10.1200/JCO.22.01856. Epub 2023 Jun 14.

    PubMed 37315297

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brachytherapy (100/110), Brachytherapy (125/145) and External Beam Radiation Therapy in people with Prostate Cancer, run by Radiation Therapy Oncology Group at 170 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 170 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

5-Year Freedom From Progression Rate (time frame: From randomization to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00063882, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.

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