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Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer

Primary Purpose

Prostate Cancer

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

PBRT

PLNRT

LHRH agonist

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, adenocarcinoma of the prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

Adenocarcinoma of the prostate treated primarily with radical prostatectomy, pathologically proven to be lymph node negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (undissected pelvic lymph nodes [Nx]), i.e. lymph node dissection is not required;
• Any type of radical prostatectomy will be permitted, including retropubic, perineal, laparoscopic or robotically assisted. There is no time limit for the date of radical prostatectomy.
A post-radical prostatectomy entry prostate-specific antigen (PSA) of ≥ 0.1 and < 2.0 ng/mL at least 6 weeks (45 days) after prostatectomy and within 30 days of registration;
One of the following pathologic classifications:
- T3N0/Nx disease with or without a positive prostatectomy surgical margin; or
- T2N0/Nx disease with or without a positive prostatectomy surgical margin;
Prostatectomy Gleason score of 9 or less;
Zubrod Performance Status of 0-1;
Age ≥ 18;
No distant metastases, based upon the following minimum diagnostic workup:
- History/physical examination (including digital rectal exam) within 8 weeks (60 days) prior to registration;
- A computerized tomography (CT) scan of the pelvis (with contrast if renal function is acceptable; a noncontrast CT is permitted if the patient is not a candidate for contrast) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to registration;
- Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis.
Adequate bone marrow function, within 90 days prior to registration, defined as follows:
- Platelets ≥ 100,000 cells/mm^3 based upon compete blood count (CBC);
- Hemoglobin ≥ 10.0 g/dl based upon CBC (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is recommended).
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x the upper limit of normal within 90 days prior to registration;
Serum total testosterone must be ≥ 40% of the lower limit of normal (LLN) of the assay used (testosterone ÷ LLN must be ≥ 0.40) within 90 days prior to registration (Note: Patients who have had a unilateral orchiectomy are eligible as long as this requirement is met);
Patients must sign a study-specific informed consent prior to study entry.

Exclusion Criteria:

A palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer;
N1 patients are ineligible, as are those with pelvic lymph node enlargement ≥ 1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged lymph node is sampled and is negative;
Androgen deprivation therapy started prior to prostatectomy for > 6 months (180 days) duration. Note: The use of finasteride or dutasteride (±tamsulosin) for longer periods prior to prostatectomy is acceptable;
Androgen deprivation therapy started after prostatectomy and prior to registration (Note: The use of finasteride or dutasteride (±tamsulosin) after prostatectomy is not acceptable - must be stopped within 3 months after prostatectomy. Androgen deprivation therapy must be stopped within 3 months after prostatectomy);
Neoadjuvant chemotherapy before or after prostatectomy;
Prior chemotherapy for any other disease site if given within 5 years prior to registration;
Prior cryosurgery or brachytherapy of the prostate; prostatectomy should be the primary treatment and not a salvage procedure;
Prior pelvic radiotherapy;
Prior invasive malignancy (except non-melanomatous skin cancer) or superficial bladder cancer unless disease free for a minimum of 5 years [for example, carcinoma in situ of the oral cavity is permissible];
Severe, active co-morbidity, defined as follows:
- History of inflammatory bowel disease;
- History of hepatitis B or C; Blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis.
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
- Transmural myocardial infarction within the last 6 months;
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
- Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; AST or ALT are required; note, however, that laboratory tests for coagulation parameters are not required for entry into this protocol.
- Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; Note, however, that human immunodeficiency viruses (HIV) testing is not required for entry into this protocol. The need to exclude patients with acquired immunodeficiency syndrome (AIDS) from this protocol is necessary because the treatments involved in this protocol may result in increased toxicity and immunosuppression.
Prior allergic reaction to the study drug(s) involved in this protocol.

Sites / Locations

UAB Comprehensive Cancer Center
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Arizona Center for Cancer Care - Peoria
Arizona Oncology Services Foundation
Arizona Oncology - Tucson
Auburn Radiation Oncology
Peninsula Medical Center
Radiation Oncology Centers - Cameron Park
Mercy Cancer Center at Mercy San Juan Medical Center
East Bay Radiation Oncology Center
Valley Medical Oncology Consultants - Castro Valley
Enloe Cancer Center at Enloe Medical Center
Valley Medical Oncology
Washington Township Hospital
California Cancer Center - Woodward Park Office
Cancer Care Associates
Rebecca and John Moores UCSD Cancer Center
Veterans Affairs Medical Center - Long Beach
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
USC/Norris Comprehensive Cancer Center and Hospital
Contra Costa Regional Medical Center
Providence Holy Cross Cancer Center
Memorial Medical Center
El Camino Hospital Cancer Center
Sutter Health - Western Division Cancer Research Group
Alta Bates Summit Medical Center - Summit Campus
Bay Area Breast Surgeons, Incorporated
CCOP - Bay Area Tumor Institute
Larry G Strieff MD Medical Corporation
Tom K Lee, Incorporated
St. Joseph Hospital Regional Cancer Center - Orange
Feather River Hospital Cancer Center
Radiation Oncology Center - Roseville
Radiological Associates of Sacramento Medical Group, Incorporated
University of California Davis Cancer Center
Mercy General Hospital
Saint Helena Hospital
UCSF Helen Diller Family Comprehensive Cancer Center
California Pacific Medical Center - California Campus
Doctors Medical Center - San Pablo Campus
Solano Radiation Oncology Center
Sutter Solano Medical Center
Aurora Presbyterian Hospital
Rocky Mountain Cancer Centers - Aurora
University of Colorado Cancer Center at UC Health Sciences Center
Boulder Community Hospital
St. Anthony Central Hospital
Porter Adventist Hospital
Presbyterian - St. Luke's Medical Center
St. Joseph Hospital
Swedish Medical Center
North Colorado Medical Center
Hope Cancer Care Center at Longmont United Hospital
McKee Medical Center
St. Mary - Corwin Regional Medical Center
North Suburban Medical Center
Exempla Lutheran Medical Center
Middlesex Hospital Cancer Center
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
William W. Backus Hospital
CCOP - Christiana Care Health Services
Washington Cancer Institute at Washington Hospital Center
University of Florida Shands Cancer Center
Integrated Community Oncology Network
Baptist Cancer Institute - Jacksonville
Integrated Community Oncology Network at Southside Cancer Center
Baptist Medical Center South
Baptist-South Miami Regional Cancer Program
Integrated Community Oncology Network - Orange Park
Florida Hospital Cancer Institute at Florida Hospital Orlando
Florida Cancer Center - Palatka
Flagler Cancer Center
Veterans Affairs Medical Center - Tampa
Emory Crawford Long Hospital
Piedmont Hospital
Winship Cancer Institute of Emory University
Northside Hospital Cancer Center
John B. Amos Cancer Center
Northside Hospital-Forsyth
Piedmont Fayette Hospital
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Kapiolani Medical Center at Pali Momi
Cancer Research Center of Hawaii
Queen's Cancer Institute at Queen's Medical Center
Straub Clinic and Hospital, Incorporated
Hawaii Medical Center - East
Pacific Cancer Institute - Maui
Saint Alphonsus Cancer Care Center at Saint Alphonsus Regional Medical Center
Mount Sinai Hospital Medical Center
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
University of Chicago Cancer Research Center
Creticos Cancer Center at Advocate Illinois Masonic Medical Center
Decatur Memorial Hospital Cancer Care Institute
Leonard C. Ferguson Cancer Center
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Veterans Affairs Medical Center - Hines
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
Cancer Institute at St. John's Hospital
Regional Cancer Center at Memorial Medical Center
Elkhart General Hospital
Radiation Oncology Associates Southwest
Parkview Regional Cancer Center at Parkview Health
Center for Cancer Care at Goshen General Hospital
Howard Community Hospital
Center for Cancer Therapy at LaPorte Hospital and Health Services
Saint Joseph Regional Medical Center
CCOP - Northern Indiana CR Consortium
Memorial Hospital of South Bend
CCOP - Iowa Oncology Research Association
John Stoddard Cancer Center at Iowa Methodist Medical Center
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Medical Oncology and Hematology Associates at Mercy Cancer Center
Mercy Cancer Center at Mercy Medical Center - Des Moines
John Stoddard Cancer Center at Iowa Lutheran Hospital
Siouxland Hematology-Oncology Associates, LLP
Mercy Medical Center - Sioux City
St. Luke's Regional Medical Center
Cancer Center of Kansas, PA - Dodge City
Cancer Center of Kansas, PA - El Dorado
Lawrence Memorial Hospital
Cancer Center of Kansas, PA - Wellington
Associates in Womens Health, PA - North Review
Cancer Center of Kansas, PA - Medical Arts Tower
Cancer Center of Kansas, PA - Wichita
CCOP - Wichita
Via Christi Cancer Center at Via Christi Regional Medical Center
Wesley Medical Center
Cancer Center of Kansas, PA - Winfield
Lucille P. Markey Cancer Center at University of Kentucky
Norton Suburban Hospital
Tulane Cancer Center Office of Clinical Research
Mary Bird Perkins Cancer Center - Baton Rouge
MBCCOP - LSU Health Sciences Center
Medical Center of Louisiana - New Orleans
CCOP - Ochsner
Greenebaum Cancer Center at University of Maryland Medical Center
Greater Baltimore Medical Center Cancer Center
St. Agnes Hospital Cancer Center
Central Maryland Oncology Center
Tate Cancer Center at Baltimore Washington Medical Center
Holy Cross Hospital
Massachusetts General Hospital
Dana-Farber/Brigham and Women's Cancer Center
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston University Cancer Research Center
Beth Israel Deaconess Medical Center
Hudner Oncology Center at Saint Anne's Hospital - Fall River
Cape Cod Hospital
Lowell General Hospital
Hickman Cancer Center at Bixby Medical Center
Saint Joseph Mercy Cancer Center
CCOP - Michigan Cancer Research Consortium
University of Michigan Comprehensive Cancer Center
Henry Ford Macomb Hospital
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Josephine Ford Cancer Center at Henry Ford Hospital
Genesys Hurley Cancer Institute
Hurley Medical Center
McLaren Cancer Institute
Van Elslander Cancer Center at St. John Hospital and Medical Center
Foote Memorial Hospital
Borgess Medical Center
West Michigan Cancer Center
Bronson Methodist Hospital
Sparrow Regional Cancer Center
St. Mary Mercy Hospital
St. Joseph Mercy Oakland
Mercy Regional Cancer Center at Mercy Hospital
William Beaumont Hospital - Royal Oak Campus
Seton Cancer Institute at Saint Mary's - Saginaw
Lakeland Regional Cancer Care Center - St. Joseph
St. John Macomb Hospital
MeritCare Bemidji
Fairview Ridges Hospital
Mercy and Unity Cancer Center at Mercy Hospital
St. Luke's Hospital Cancer Care Center
Fairview Southdale Hospital
Mercy and Unity Cancer Center at Unity Hospital
Immanuel St. Joseph's
HealthEast Cancer Care at St. John's Hospital
Minnesota Oncology - Maplewood
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Hennepin County Medical Center - Minneapolis
Humphrey Cancer Center at North Memorial Outpatient Center
Mayo Clinic Cancer Center
CCOP - Metro-Minnesota
Park Nicollet Cancer Center
Regions Hospital Cancer Care Center
United Hospital
St. Francis Cancer Center at St. Francis Medical Center
Ridgeview Medical Center
Willmar Cancer Center at Rice Memorial Hospital
Minnesota Oncology - Woodbury
Regional Cancer Center at Singing River Hospital
Cancer Institute of Cape Girardeau, LLC
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Barnes-Jewish West County Hospital
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - St. Peters
CCOP - Montana Cancer Consortium
Billings Clinic - Downtown
Bozeman Deaconess Cancer Center
Great Falls Clinic - Main Facility
Sletten Cancer Institute at Benefis Healthcare
Cancer Resource Center - Lincoln
Saint Elizabeth Cancer Institute at Saint Elizabeth Regional Medical Center
CCOP - Missouri Valley Cancer Consortium
Methodist Estabrook Cancer Center
Immanuel Medical Center
Alegant Health Cancer Center at Bergan Mercy Medical Center
Lakeside Hospital
Creighton University Medical Center
Nebraska Medical Center
CCOP - Nevada Cancer Research Foundation
Center for Cancer Care at Exeter Hospital
Kingsbury Center for Cancer Care at Cheshire Medical Center
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Memorial Sloan-Kettering Cancer Center - Basking Ridge
AtlantiCare Cancer Care Institute at AtlantiCare Regional Medical Center - Mainland Campus
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Saint Peter's University Hospital
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
Capital Health Regional Cancer Center
Valley Hospital - Ridgewood
Somerset Medical Center
Frederick R. and Betty M. Smith Cancer Treatment Center
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Cancer Institute of New Jersey at Cooper - Voorhees
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
New Mexico Cancer Center
University of New Mexico Cancer Center
University of New Mexico Cancer Center - South
New York Oncology Hematology, PC at Albany Regional Cancer Care
New York Methodist Hospital
Roswell Park Cancer Institute
Sands Cancer Center
Memorial Sloan-Kettering Cancer Center
Stich Radiation Center at NewYork-Presbyterian Hospital/Weill Cornell Medical Center
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
Dyson Center for Cancer Care at Vassar Brothers Medical Center
Hudson Valley Oncology Associates
Highland Hospital of Rochester
Lipson Cancer and Blood Center at Rochester General Hospital
University Radiation Oncology at Parkridge Hospital
James P. Wilmot Cancer Center at University of Rochester Medical Center
Memorial Sloan-Kettering Cancer Center - Rockville Centre
Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center
Randolph Hospital
Mission Hospitals - Memorial Campus
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Blumenthal Cancer Center at Carolinas Medical Center
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Coleman Radiation Oncology Center at Carter General Hospital
CarolinaEast Cancer Care
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center
Rex Cancer Center at Rex Hospital
Annie Penn Cancer Center
South Atlantic Radiation Oncology, LLC
Coastal Carolina Radiation Oncology Center
Zimmer Cancer Center at New Hanover Regional Medical Center
MeritCare Broadway
CCOP - MeritCare Hospital
Roger Maris Cancer Center at MeritCare Hospital
Altru Cancer Center at Altru Hospital
McDowell Cancer Center at Akron General Medical Center
Summa Center for Cancer Care at Akron City Hospital
Barberton Citizens Hospital
Aultman Cancer Center at Aultman Hospital
Adena Regional Medical Center
Case Comprehensive Cancer Center
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland Clinic Taussig Cancer Center
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Riverside Methodist Hospital Cancer Care
CCOP - Columbus
Grant Medical Center Cancer Care
Mount Carmel Health - West Hospital
Doctors Hospital at Ohio Health
Grady Memorial Hospital
Community Cancer Center
Hematology Oncology Center
Cleveland Clinic Cancer Center
Lima Memorial Hospital
Strecker Cancer Center at Marietta Memorial Hospital
Northwest Ohio Oncology Center
Hillcrest Cancer Center at Hillcrest Hospital
Lake/University Ireland Cancer Center
Southwest General Health Center
Licking Memorial Cancer Care Program at Licking Memorial Hospital
UHHS Chagrin Highlands Medical Center
St. Charles Mercy Hospital
Parma Community General Hospital
Southern Ohio Medical Center Cancer Center
Cancer Care Center, Incorporated
North Coast Cancer Care, Incorporated
Community Hospital of Springfield and Clark County
Tony Teramana Cancer Center
Cleveland Clinic Foundation - Strongsville
Flower Hospital Cancer Center
Mercy Hospital of Tiffin
Toledo Hospital
St. Vincent Mercy Medical Center
Medical University of Ohio Cancer Center
CCOP - Toledo Community Hospital
St. Anne Mercy Hospital
Toledo Clinic, Incorporated - Main Clinic
Mount Carmel St. Ann's Cancer Center
UHHS Westlake Medical Center
Cancer Treatment Center
Cleveland Clinic - Wooster
Genesis - Good Samaritan Hospital
Oklahoma University Cancer Institute
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Willamette Valley Cancer Center - Eugene
Three Rivers Community Hospital
Legacy Mount Hood Medical Center
Dubs Cancer Center at Rogue Valley Medical Center
Providence Cancer Center at PMCC
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
Salem Hospital Regional Cancer Care Services
Legacy Meridian Park Hospital
Rosenfeld Cancer Center at Abington Memorial Hospital
UPMC Cancer Center at Beaver Medical Center
St. Luke's Cancer Network at St. Luke's Hospital
Bryn Mawr Hospital
UPMC Cancer Center at Jefferson Regional Medical Center
Geisinger Cancer Institute at Geisinger Health
Northeast Radiation Oncology Center
Adams Cancer Center
UPMC Cancer Center - Arnold Palmer Pavilion
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
UPMC Cancer Center at the John P. Murtha Pavilion
Lancaster General Hospital
St. Mary Regional Cancer Center
UPMC Cancer Center at UPMC McKeesport
Upper Delaware Valley Cancer Center
Intercommunity Cancer Center
UPMC - Moon
Alle-Kiski Medical Center
UPMC Cancer Center - Natrona Heights
Jameson Memorial Hospital - North Campus
Cancer Center of Paoli Memorial Hospital
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Fox Chase Cancer Center - Philadelphia
Albert Einstein Cancer Center
Allegheny Cancer Center at Allegheny General Hospital
UPMC - Shadyside
UPMC Cancer Center at Magee-Womens Hospital
UPMC Cancer Center at UPMC Presbyterian
UPMC Cancer Center at UPMC St. Margaret
UPMC Cancer Center at UPMC Passavant
UPMC Cancer Center - Upper St. Clair
St. Joseph Medical Center
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Washington Hospital Cancer Center
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
CCOP - Main Line Health
Lankenau Cancer Center at Lankenau Hospital
York Cancer Center at Apple Hill Medical Center
AnMed Cancer Center
Hollings Cancer Center at Medical University of South Carolina
Cancer Centers of the Carolinas - Faris Road
Cancer Centers of the Carolinas - Grove Commons
Cancer Centers of the Carolinas - Eastside
CCOP - Greenville
Cancer Centers of the Carolinas - Greer Medical Oncology
Cancer Centers of the Carolinas - Greer Radiation Oncology
Hilton Head Radiation Oncology Center
Cancer Centers of the Carolinas - Seneca
CCOP - Upstate Carolina
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Cancer Centers of the Carolinas - Spartanburg
Rapid City Regional Hospital
West Tennessee Cancer Center at Jackson-Madison County General Hospital
Texas Oncology, PA at Harris Center HEB
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Texas Oncology, PA at Texas Cancer Center - Denton South
Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital
University of Texas Medical Branch
Memorial Hermann Hospital - Memorial City
Texas Oncology, PA at Lake Vista Cancer Center
Longview Cancer Center
Cancer Care Centers of South Texas - Northeast
Texas Oncology, PA at Texas Cancer Center - Sherman
Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land
Tyler Cancer Center
Texas Oncology, PA - Wichita Falls
Sandra L. Maxwell Cancer Center
Logan Regional Hospital
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Utah Valley Regional Medical Center - Provo
Dixie Regional Medical Center - East Campus
Utah Cancer Specialists at UCS Cancer Center
Huntsman Cancer Institute at University of Utah
LDS Hospital
Fletcher Allen Health Care - University Health Center Campus
Norris Cotton Cancer Center - North
INOVA Alexandria Hospital
Martha Jefferson Hospital Cancer Care Center
Danville Regional Medical Center
Sentara Cancer Institute at Sentara Norfolk General Hospital
Naval Medical Center - Portsmouth
Veterans Affairs Medical Center - Richmond
Coastal Cancer Center at Sentara Virginia Beach General Hospital
St. Joseph Cancer Center
St. Francis Hospital
Good Samaritan Cancer Center
CCOP - Virginia Mason Research Center
Virginia Mason Medical Center
Cancer Care Northwest - Spokane South
Franciscan Cancer Center at St. Joseph Medical Center
CCOP - Northwest
MultiCare Regional Cancer Center at Tacoma General Hospital
Legacy Salmon Creek Medical Center
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
West Virginia University Health Sciences Center - Charleston
Langlade Memorial Hospital
Fox Valley Hematology and Oncology - East Grant Street
Theda Care Cancer Institute
Beloit Memorial Hospital
Central Wisconsin Cancer Program at Agnesian HealthCare
Bellin Memorial Hospital
St. Vincent Hospital Regional Cancer Center
Franciscan Skemp Healthcare - La Crosse Campus
Gundersen Lutheran Center for Cancer and Blood
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Bay Area Cancer Care Center at Bay Area Medical Center
Community Memorial Hospital Cancer Care Center
Columbia Saint Mary's Hospital - Ozaukee
Columbia-Saint Mary's Water Tower Medical Commons
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center
Medical College of Wisconsin Cancer Center
Veterans Affairs Medical Center - Milwaukee
D.N. Greenwald Center
Regional Cancer Center at Oconomowoc Memorial Hospital
All Saints Cancer Center at Wheaton Franciscan Healthcare
Door County Cancer Center at Door County Memorial Hospital
Aurora Medical Center
Waukesha Memorial Hospital Regional Cancer Center
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
West Allis Memorial Hospital
Riverview UW Cancer Center at Riverview Hospital
Rocky Mountain Oncology
Tom Baker Cancer Centre - Calgary
Cross Cancer Institute at University of Alberta
Saint John Regional Hospital
Doctor H. Bliss Murphy Cancer Centre
Margaret and Charles Juravinski Cancer Centre
London Regional Cancer Program at London Health Sciences Centre
Cancer Care Program at Thunder Bay Regional Health Sciences
Maisonneuve-Rosemont Hospital
Hopital Notre-Dame du CHUM
Centre Hospitalier Universitaire de Quebec
CHUS-Hopital Fleurimont
Allan Blair Cancer Centre at Pasqua Hospital
Saskatoon Cancer Centre at the University of Saskatchewan
Pamela Youde Nethersole Eastern Hospital
Rabin Medical Center - Beilinson Campus
Tel-Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

PBRT Alone

PBRT + STAD

PLNRT + PBRT + STADT

Arm Description

Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.

Prostate bed radiotherapy (PBRT) and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before radiotherapy (RT), and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).

Pelvic lymph node radiotherapy (PLNRT), prostate bed radiotherapy (PBRT), and short term androgen deprivation therapy (STAD) consisting of antiandrogen (AA) and luteinizing hormone-releasing hormone (LHRH) agonist therapy begins within 6 weeks (+/- 2 weeks) after registration. STAD starts first, 2 months (+/- 2 weeks) before RT, and lasts for 4-6 months. LHRH can last 4-6 months. AA starts at the same time as LHRH (or up to 2 weeks prior ), lasts approximately 4 months, and should end on the last day of RT (+/- 2 weeks).

Outcomes

Primary Outcome Measures

Percentage of Participants Free From Progression (FFP) at 5 Years

Progression is defined as the first occurrence of the following events: biochemical failure by the Phoenix definition (prostate-specific antigen [PSA] ≥ 2 ng/ml over the nadir PSA), clinical failure (local, regional or distant), or death from any cause. The initiation of second salvage therapy before progression was a protocol violation and resulted in censoring. Progression time is defined as time from randomization to the date of progression, second salvage therapy (censored), or last known follow-up (censored). Freedom from progression rates are estimated using the Kaplan-Meier method. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but results were reported early. See Limitations and Caveats section.

Secondary Outcome Measures

Percentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure)

Secondary biochemical (failure) is defined as either of two occurrences: 1. For detectable post-baseline PSA values (≥ 0.1), the first occurrence of a PSA value that is both ≥ 0.4 and a second rise above nadir; 2.The start of second salvage therapy. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but results were reported early. See Limitations and Caveats section.

Percentage of Participants Free From Hormone-refractory Disease (Castrate-resistant Disease)

Hormone-refractory disease (failure) is defined as three rises in PSA after the start of second salvage androgen deprivation therapy. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.

Percentage of Participants With Local Failure

Local failure is defined as first occurrence of local clinical progression. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.

Percentage of Participants With Distant Metastasis

Distant metastasis (failure) is defined as the occurrence of distant metastasis determined by imaging. Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.

Percentage of Participants Who Died Due to Prostate Cancer (Cause-specific Mortality)

Cause-specific mortality (failure) is defined as death due to prostate cancer or complications of protocol treatment (centrally reviewed), or death following disease progression (clinical or biochemical) in the absence of or after the initiation of any salvage therapy. [Biochemical progression is indicated by any rise in PSA.] Failure time is defined as time from randomization to the date of failure, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.

Percentage of Participants Alive (Overall Mortality)

Survival time is defined as time from randomization to the date of death from any cause or last known follow-up (censored). Survival rates are estimated by the Kaplan-Meier method. Pairwise comparisons of the overall distributions of failure times are reported in statistical analysis section, with five-year rates reported here. The study was designed for the final analysis to occur after all participants had been on study for at least 5 years, but the data monitoring committee decided to release results after the third interim analysis.

Percentage of Participants Experiencing Grade 2+ and 3+ Adverse Events ≤ 90 Days of the Completion of Radiotherapy (RT)

Common Terminology Criteria for Adverse Events (version 3.0) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data. Pairwise comparisons of Arm 2 vs Arm 1 and Arm 3 vs. Arm 2 are reported in the statistical analysis.

Percentage of Participants Experiencing Late Grade 2+ and 3+ Adverse Events > 90 Days From the Completion of Radiotherapy (RT)

Common Terminology Criteria for Adverse Events (version 3.0) grades adverse event severity from 1=mild to 5=death. Late adverse events (AE) are defined as occurring > 90 days from the completion of RT. Failure time is defined as time from randomization to the date of first late grade 2 or grade 3 adverse event, death (competing risk), or last known follow-up (censored). Failure rates for data summary are estimated using the cumulative incidence method, with 5-year rates provided here. Pairwise comparisons of the distributions of failure times between Arm 2 and Arm 1 and between Arm 3 and Arm 2, reported in the statistical analysis section, use cause-specific hazard rates for which deaths are censored.

Comparison of Disease-specific Health Related Quality of Life (HRQOL) Change by the Expanded Prostate Cancer Index Composite (EPIC), Hopkins Verbal Learning Test Revised (HVLT-R), Trail Making Test A & B, and Controlled Oral Word Association Test (COWAT)

Assessment of Mood and Depression Change Using QOL Measured by the Hopkins Symptom Checklist (HSCL-25)

Assessment and Comparison of Quality Adjusted Life Year (QALY) and Quality Adjusted FFP Year (QAFFPY)

Evaluation and Comparison of the Cost-utility Using EuroQoL - 5 Dimensions (EQ-5D)

Prognostic Value of Genomic and Proteomic Markers for the Primary and Secondary Clinical Endpoints

Assessment of the Relationship(s) Between the American Urological Association Symptom Index (AUA SI) and Urinary Morbidity (Adverse Event Terms: Urinary Frequency/Urgency) Using the CTCAE v. 3.0 Grading System

Full Information

NCT ID

NCT00567580

First Posted

December 4, 2007

Last Updated

September 11, 2023

Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI), Cancer and Leukemia Group B, NRG Oncology

1. Study Identification

Unique Protocol Identification Number

NCT00567580

Brief Title

Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer

Official Title

A Phase III Trial of Short Term Androgen Deprivation With Pelvic Lymph Node or Prostate Bed Only Radiotherapy (SPPORT) in Prostate Cancer Patients With a Rising PSA After Radical Prostatectomy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 2008 (undefined)

Primary Completion Date

July 12, 2018 (Actual)

Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radiation Therapy Oncology Group

Collaborators

National Cancer Institute (NCI), Cancer and Leukemia Group B, NRG Oncology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen-deprivation therapy is more effective for prostate cancer. PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.

Detailed Description

OBJECTIVES: Primary To determine whether the addition of short-term androgen deprivation (STAD) to prostate bed radiotherapy (PBRT) improves freedom from progression (FFP) (i.e., maintenance of a prostate-specific antigen [PSA] less than the nadir+2 ng/mL, absence of clinical failure, and absence of death from any cause) for 5 years, over that of PBRT alone in men treated with salvage radiotherapy after radical prostatectomy. To determine whether STAD, pelvic lymph node radiotherapy (PLNRT), and PBRT improves FFP over that of STAD+PBRT and PBRT alone in men treated with salvage radiotherapy after radical prostatectomy. Secondary To compare secondary biochemical failure, the development of hormone-refractory disease , distant metastasis, cause-specific mortality, and overall mortality at five years. To compare acute and late morbidity based on Common Toxicity Criteria for Adverse Effects (CTCAE), v. 3.0. To measure the expression of cell kinetic, apoptotic pathway, and angiogenesis-related genes in archival diagnostic tissue to better define the risk of FFP, distant failure, cause-specific mortality, and overall mortality after salvage radiotherapy for prostate cancer, independently of conventional clinical parameters now used. To quantify blood product-based proteomic and genomic (single nucleotide polymorphisms) patterns and urine-based genomic patterns before and at different times after treatment to better define the risk of FFP, distant failure, cause-specific mortality, and overall mortality after salvage radiotherapy for prostate cancer, independently of conventional clinical parameters now used. To assess the degree, duration, and significant differences of disease-specific health-related quality of life (HRQOL) decrements among treatment arms. To assess whether mood is improved and depression is decreased with the more aggressive therapy if it improves FFP. To collect paraffin-embedded tissue blocks, serum, plasma, urine, and buffy coat cells for future translational research analyses. Tertiary To assess whether an incremental gain in FFP and survival with more aggressive therapy outweighs decrements in the primary generic domains of HRQOL (i.e., mobility, self care, usual activities, pain/discomfort, and anxiety/depression). To evaluate the cost-utility of the treatment arm demonstrating the most significant benefit (in terms of the primary outcome) in comparison with other widely accepted cancer and non-cancer therapies. To assess associations between serum levels of beta-amyloid and measures of cognition and mood and depression. An exploratory aim is to assess the relationship(s) between the American Urological Association Symptom Index (AUA SI) and urinary morbidity using the CTCAE v. 3.0 grading system. OUTLINE: Patients are stratified according to seminal vesicle involvement (yes vs no), prostatectomy Gleason score (≤ 7 vs 8-9), pre-radiotherapy PSA (≥ 0.1 and ≤ 1.0 ng/mL vs > 1.0 and < 2.0 ng/mL), and pathology stage (pT2 and margin negative vs all others). Patients are randomized to 1 of 3 treatment arms. Follow-up occurs 3, 6, and 12 months after the completion of radiation therapy, then every 6 months for 6 years, and then annually thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, adenocarcinoma of the prostate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1792 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PBRT Alone

Arm Type

Active Comparator

Arm Description

Prostate bed radiotherapy (PBRT) begins within 6 weeks (+/- 2 weeks) after registration.

Arm Title

PBRT + STAD

Arm Type

Experimental

Arm Description

Arm Title

PLNRT + PBRT + STADT

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

PBRT

Other Intervention Name(s)

Prostate bed radiotherapy, Three-Dimensional Conformal Radiation Therapy (3D-CRT), Intensity modulated RT (IMRT)

Intervention Description

1.8 Gy per fraction once daily, 5 days a week totaling 64.8-70.2 Gy. 3D-CRT or IMRT required.

Intervention Type

Radiation

Intervention Name(s)

PLNRT

Other Intervention Name(s)

Pelvic lymph node radiotherapy

Intervention Description

1.8 Gy per fraction once daily, 5 days a week, totaling 45 Gy. 3D-CRT or IMRT required.

Intervention Type

Drug

Intervention Name(s)

Other Intervention Name(s)

flutamide, bicalutamide

Intervention Description

Antiandrogen (AA) therapy can be either 250 mg flutamide by mouth three times a day or 50 mg bicalutamide by mouth once a day.

Intervention Type

Drug

Intervention Name(s)

LHRH agonist

Other Intervention Name(s)

leuprolide, goserelin, buserelin, triptorelin

Intervention Description

Luteinizing hormone-releasing hormone (LHRH) agonist can be any analog approved by the FDA (or by Health Canada for Canadian institutions) and may be given in any possible combination such that the total LHRH treatment time is 4-6 months. LHRH analogs are administered with a variety of techniques, including subcutaneous insertion of a solid plug in the abdominal wall, intramuscular injection, and subcutaneous injection.

Primary Outcome Measure Information:

Title

Percentage of Participants Free From Progression (FFP) at 5 Years

Description

Time Frame

From randomization to five years.

Secondary Outcome Measure Information:

Title

Percentage of Participants With Secondary Biochemical Failure (Alternative Biochemical Failure)

Description

Time Frame