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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
Open (Enrolling)
Male
Prostate Cancer

Thank you

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 InstituteBuffalo, New York  14263
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Hurley Medical CenterFlint, Michigan  48503
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Cape Cod HospitalHyannis, Massachusetts  02601
New York Methodist HospitalBrooklyn, New York  11215-3609
CCOP - ColumbusColumbus, Ohio  43206
LDS HospitalSalt Lake City, Utah  84143
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
CCOP - NorthwestTacoma, Washington  98405-0986
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901
Kaiser Permanente Medical Center - San Francisco Geary CampusSan Francisco, California  94115
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Kaiser Permanente Medical Center - OaklandSacramento, California  95825
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Sibley Memorial HospitalWashington, District of Columbia  20016
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Logan Regional HospitalLogan, Utah  84321
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Kaiser Permanente Medical Center - Santa Clara Kiely CampusSanta Clara, California  95051-5386
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt. Louis, Missouri  63110
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Beth Israel Medical Center - Petrie DivisionNew York, New York  10003-3803
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Kaiser Permanente Medical Center - SacramentoSacramento, California  95825
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
All Saints Cancer Center at Wheaton Franciscan HealthcareRacine, Wisconsin  53405
Peninsula Medical CenterBurlingame, California  94010
Sutter Health - Western Division Cancer Research GroupGreenbrae, California  94904
Kaiser Permanente Medical Center - HaywardHayward, California  94545
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Kaiser Permanente Medical Center - Redwood CityRedwood City, California  94063
Kaiser Permanente Medical Center - RichmondRichmond, California  94801
Kaiser Permanente Medical Center - RosevilleRoseville, California  95661
South Sacramento Kaiser-Permanente Medical CenterSacramento, California  95823
California Pacific Medical Center - California CampusSan Francisco, California  94118
Kaiser Permanente Medical Center - Santa TeresaSan Jose, California  95119
Kaiser Foundation Hospital - San RafaelSan Rafael, California  94903
Kaiser Permanente Medical Center - Santa RosaSanta Rosa, California  95403
Kaiser Permanente Medical Center - South San FranciscoSouth San Francisco, California  94080
Kaiser Permanente Medical Facility - StocktonStockton, California  95210
Sutter Solano Medical CenterVallejo, California  94589
Kaiser Permanente Medical Center - Walnut CreekWalnut Creek, California  94596
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical CenterBoise, Idaho  83706
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Kingsbury Center for Cancer Care at Cheshire Medical CenterKeene, New Hampshire  03431
Highland Hospital of RochesterRochester, New York  14620
Lima Memorial HospitalLima, Ohio  45804
Northwest Ohio Oncology CenterMaumee, Ohio  43537
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
St. Francis HospitalFederal Way, Washington  98003
Good Samaritan Cancer CenterPuyallup, Washington  98371
California Cancer Center - Woodward Park OfficeFresno, California  93720
Northeast Georgia Medical CenterGainesville, Georgia  30501
South Suburban Oncology CenterQuincy, Massachusetts  02169
Cancer Treatment CenterWooster, Ohio  44691
West Allis Memorial HospitalWest Allis, Wisconsin  53227
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Menorah Medical CenterOverland Park, Kansas  66209
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
St. Joseph Medical CenterKansas City, Missouri  64114
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Research Medical CenterKansas City, Missouri  64132
Liberty HospitalLiberty, Missouri  64068
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Saint Joseph Oncology, IncorporatedSaint Joseph, Missouri  64507
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
Grant Medical Center Cancer CareColumbus, Ohio  43215
Hematology Oncology CenterElyria, Ohio  44035
Community Cancer CenterElyria, Ohio  44035
Flower Hospital Cancer CenterSylvania, Ohio  43560
St. Anne Mercy HospitalToledo, Ohio  43623
Mount Carmel St. Ann's Cancer CenterWesterville, Ohio  43081
McGlinn Family Regional Cancer Center at Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
York Cancer Center at Apple Hill Medical CenterYork, Pennsylvania  17405
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
Fredericksburg Oncology, IncorporatedFredericksburg, Virginia  22401
Franciscan Cancer Center at St. Joseph Medical CenterTacoma, Washington  98405-3004
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Hospital of Saint RaphaelNew Haven, Connecticut  06511
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
Solano Radiation Oncology CenterVacaville, California  95687
Parvin Radiation OncologyKansas City, Missouri  64116
Mercy General HospitalSacramento, California  95819
East Bay Radiation Oncology CenterCastro Valley, California  94546
Contra Costa Regional Medical CenterMartinez, California  94553-3156
El Camino Hospital Cancer CenterMountain View, California  94040
Larry G Strieff MD Medical CorporationOakland, California  94609
Tom K Lee, IncorporatedOakland, California  94609
Bay Area Breast Surgeons, IncorporatedOakland, California  94609
Fountain Valley, California  92708
Cancer Care Center, IncorporatedSalem, Ohio  44460
Valley Medical Oncology Consultants - Castro ValleyCastro Valley, California  94546
Valley Medical OncologyFremont, California  94538
Columbia Saint Mary's Hospital - OzaukeeMequon, Wisconsin  53097
Columbia-Saint Mary's Cancer Care CenterMilwaukee, Wisconsin  53211
Radiation Oncology CenterAlliance, Ohio  44601
Auburn Radiation OncologyAuburn, California  95603
Radiation Oncology Centers - Cameron ParkCameron Park, California  95682
Radiation Oncology Center - RosevilleRoseville, California  95661
Mercy Cancer Center at Mercy San Juan Medical CenterCarmichael, California  95608
Kaiser Permanente - Division of Research - OaklandOakland, California  94611
Kaiser Permanente Medical Center - Rancho CordovaRancho Cordova, California  95670
Rohnert Park Cancer CenterRohnert Park, California  94928
South Sacramento Cancer CenterSacramento, California  95823
CCOP - Kansas CityPrairie Village, Kansas  66208
St. Agnes Hospital Cancer CenterBaltimore, Maryland  21229
Shields Radiation Oncology Center - MansfieldMansfield, Massachusetts  02048
Winchester Hospital Radiation Oncology CenterWinchester, Massachusetts  01890
Barnes-Jewish West County HospitalSaint Louis, Missouri  63141
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. PetersSaint Peters, Missouri  63376
Nevada Cancer InstituteLas Vegas, Nevada  89135
Renown Institute for Cancer at Renown Regional Medical CenterReno, Nevada  89502
Sands Cancer CenterCanandiaqua, New York  14424
University Radiation Oncology at Parkridge HospitalRochester, New York  14626
Coleman Radiation Oncology Center at Carter General HospitalMorehead City, North Carolina  28557
CarolinaEast Cancer CareNew Bern, North Carolina  28560
South Atlantic Radiation Oncology, LLCSupply, North Carolina  28462
Coastal Carolina Radiation Oncology CenterWilmington, North Carolina  28401
Norris Cotton Cancer Center - NorthSaint Johnsbury, Vermont  05819