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
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
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
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 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Freedom from progression
Safety Issue:
No
Principal Investigator
Bradley R. Prestidge, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Hermann Southwest Hospital
Authority:
United States: Federal Government
Study ID:
CDR0000288823
NCT ID:
NCT00063882
Start Date:
June 2003
Completion Date:
Related Keywords:
- Prostate Cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- adenocarcinoma of the prostate
- Prostatic Neoplasms
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Hurley Medical Center | Flint, Michigan 48503 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
| Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| St. John Macomb Hospital | Warren, Michigan 48093 |
| Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre, Pennsylvania 18711 |
| CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
| Cape Cod Hospital | Hyannis, Massachusetts 02601 |
| New York Methodist Hospital | Brooklyn, New York 11215-3609 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| LDS Hospital | Salt Lake City, Utah 84143 |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| MultiCare Regional Cancer Center at Tacoma General Hospital | Tacoma, Washington 98405 |
| CCOP - Northwest | Tacoma, Washington 98405-0986 |
| Utah Valley Regional Medical Center - Provo | Provo, Utah 84604 |
| Veterans Affairs Medical Center - Richmond | Richmond, Virginia 23249 |
| Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Milwaukee, Wisconsin 53201-2901 |
| Kaiser Permanente Medical Center - San Francisco Geary Campus | San Francisco, California 94115 |
| St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
| CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
| Kaiser Permanente Medical Center - Oakland | Sacramento, California 95825 |
| Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
| Toledo Hospital | Toledo, Ohio 43606 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| Sibley Memorial Hospital | Washington, District of Columbia 20016 |
| Adena Regional Medical Center | Chillicothe, Ohio 54601 |
| Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| Grady Memorial Hospital | Delaware, Ohio 43015 |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
| Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
| Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
| Logan Regional Hospital | Logan, Utah 84321 |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City, Utah 84106 |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
| Kaiser Permanente Medical Center - Santa Clara Kiely Campus | Santa Clara, California 95051-5386 |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | St. Louis, Missouri 63110 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
| Beth Israel Medical Center - Petrie Division | New York, New York 10003-3803 |
| Geisinger Cancer Institute at Geisinger Health | Danville, Pennsylvania 17822-0001 |
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
| Kaiser Permanente Medical Center - Sacramento | Sacramento, California 95825 |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
| Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton | Marlton, New Jersey 08053 |
| Fox Chase Virtua Health Cancer Program at Virtua West Jersey | Voorhees, New Jersey 08043 |
| Mount Carmel Health - West Hospital | Columbus, Ohio 43222 |
| Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
| All Saints Cancer Center at Wheaton Franciscan Healthcare | Racine, Wisconsin 53405 |
| Peninsula Medical Center | Burlingame, California 94010 |
| Sutter Health - Western Division Cancer Research Group | Greenbrae, California 94904 |
| Kaiser Permanente Medical Center - Hayward | Hayward, California 94545 |
| Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
| Kaiser Permanente Medical Center - Redwood City | Redwood City, California 94063 |
| Kaiser Permanente Medical Center - Richmond | Richmond, California 94801 |
| Kaiser Permanente Medical Center - Roseville | Roseville, California 95661 |
| South Sacramento Kaiser-Permanente Medical Center | Sacramento, California 95823 |
| 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 |
| Kaiser Permanente Medical Center - Santa Rosa | Santa Rosa, California 95403 |
| Kaiser Permanente Medical Center - South San Francisco | South San Francisco, California 94080 |
| Kaiser Permanente Medical Facility - Stockton | Stockton, California 95210 |
| Sutter Solano Medical Center | Vallejo, California 94589 |
| Kaiser Permanente Medical Center - Walnut Creek | Walnut Creek, California 94596 |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
| Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
| Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
| Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene, New Hampshire 03431 |
| Highland Hospital of Rochester | Rochester, New York 14620 |
| Lima Memorial Hospital | Lima, Ohio 45804 |
| Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
| St. Charles Mercy Hospital | Oregon, Ohio 43616 |
| North Coast Cancer Care, Incorporated | Sandusky, Ohio 44870 |
| Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
| Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
| Dixie Regional Medical Center - East Campus | Saint George, Utah 84770 |
| St. Francis Hospital | Federal Way, Washington 98003 |
| Good Samaritan Cancer Center | Puyallup, Washington 98371 |
| California Cancer Center - Woodward Park Office | Fresno, California 93720 |
| Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
| South Suburban Oncology Center | Quincy, Massachusetts 02169 |
| Cancer Treatment Center | Wooster, Ohio 44691 |
| West Allis Memorial Hospital | West Allis, Wisconsin 53227 |
| Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
| Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
| Menorah Medical Center | Overland Park, Kansas 66209 |
| Foote Memorial Hospital | Jackson, Michigan 49201 |
| St. Mary Mercy Hospital | Livonia, Michigan 48154 |
| St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
| St. Joseph Medical Center | Kansas City, Missouri 64114 |
| North Kansas City Hospital | Kansas City, Missouri 64116 |
| Saint Luke's Cancer Institute at Saint Luke's Hospital | Kansas City, Missouri 64111 |
| Research Medical Center | Kansas City, Missouri 64132 |
| Liberty Hospital | Liberty, Missouri 64068 |
| Heartland Regional Medical Center | Saint Joseph, Missouri 64506 |
| Saint Joseph Oncology, Incorporated | Saint Joseph, Missouri 64507 |
| Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
| Barberton Citizens Hospital | Barberton, Ohio 44203 |
| Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210-1240 |
| Grant Medical Center Cancer Care | Columbus, Ohio 43215 |
| Hematology Oncology Center | Elyria, Ohio 44035 |
| Community Cancer Center | Elyria, Ohio 44035 |
| Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
| St. Anne Mercy Hospital | Toledo, Ohio 43623 |
| Mount Carmel St. Ann's Cancer Center | Westerville, Ohio 43081 |
| McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
| York Cancer Center at Apple Hill Medical Center | York, Pennsylvania 17405 |
| Sandra L. Maxwell Cancer Center | Cedar City, Utah 84720 |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray, Utah 84157 |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden, Utah 84403 |
| Fredericksburg Oncology, Incorporated | Fredericksburg, Virginia 22401 |
| Franciscan Cancer Center at St. Joseph Medical Center | Tacoma, Washington 98405-3004 |
| Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
| Arizona Oncology Services Foundation | Phoenix, Arizona 85013 |
| Radiological Associates of Sacramento Medical Group, Incorporated | Sacramento, California 95815 |
| Hospital of Saint Raphael | New Haven, Connecticut 06511 |
| Cancer Institute at St. John's Hospital | Springfield, Illinois 62701 |
| Solano Radiation Oncology Center | Vacaville, California 95687 |
| Parvin Radiation Oncology | Kansas City, Missouri 64116 |
| Mercy General Hospital | Sacramento, California 95819 |
| East Bay Radiation Oncology Center | Castro Valley, California 94546 |
| Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
| El Camino Hospital Cancer Center | Mountain View, California 94040 |
| Larry G Strieff MD Medical Corporation | Oakland, California 94609 |
| Tom K Lee, Incorporated | Oakland, California 94609 |
| Bay Area Breast Surgeons, Incorporated | Oakland, California 94609 |
| Fountain Valley, California 92708 | |
| Cancer Care Center, Incorporated | Salem, Ohio 44460 |
| Valley Medical Oncology Consultants - Castro Valley | Castro Valley, California 94546 |
| Valley Medical Oncology | Fremont, California 94538 |
| Columbia Saint Mary's Hospital - Ozaukee | Mequon, Wisconsin 53097 |
| Columbia-Saint Mary's Cancer Care Center | Milwaukee, Wisconsin 53211 |
| Radiation Oncology Center | Alliance, Ohio 44601 |
| Auburn Radiation Oncology | Auburn, California 95603 |
| Radiation Oncology Centers - Cameron Park | Cameron Park, California 95682 |
| Radiation Oncology Center - Roseville | Roseville, California 95661 |
| Mercy Cancer Center at Mercy San Juan Medical Center | Carmichael, California 95608 |
| Kaiser Permanente - Division of Research - Oakland | Oakland, California 94611 |
| Kaiser Permanente Medical Center - Rancho Cordova | Rancho Cordova, California 95670 |
| Rohnert Park Cancer Center | Rohnert Park, California 94928 |
| South Sacramento Cancer Center | Sacramento, California 95823 |
| CCOP - Kansas City | Prairie Village, Kansas 66208 |
| St. Agnes Hospital Cancer Center | Baltimore, Maryland 21229 |
| Shields Radiation Oncology Center - Mansfield | Mansfield, Massachusetts 02048 |
| Winchester Hospital Radiation Oncology Center | Winchester, Massachusetts 01890 |
| Barnes-Jewish West County Hospital | Saint Louis, Missouri 63141 |
| Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters | Saint Peters, Missouri 63376 |
| Nevada Cancer Institute | Las Vegas, Nevada 89135 |
| Renown Institute for Cancer at Renown Regional Medical Center | Reno, Nevada 89502 |
| Sands Cancer Center | Canandiaqua, New York 14424 |
| University Radiation Oncology at Parkridge Hospital | Rochester, New York 14626 |
| Coleman Radiation Oncology Center at Carter General Hospital | Morehead City, North Carolina 28557 |
| CarolinaEast Cancer Care | New Bern, North Carolina 28560 |
| South Atlantic Radiation Oncology, LLC | Supply, North Carolina 28462 |
| Coastal Carolina Radiation Oncology Center | Wilmington, North Carolina 28401 |
| Norris Cotton Cancer Center - North | Saint Johnsbury, Vermont 05819 |
