Prostate Cancer Clinical Trial
Radiation Therapy With or Without Bicalutamide for Recurrent pT3N0 Prostate Cancer After Radical Prostatectomy
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using bicalutamide may fight prostate cancer by reducing the production of androgens. It is not yet known if radiation therapy is more effective with or without bicalutamide for prostate cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without bicalutamide in treating patients who have stage II or stage III prostate cancer and elevated prostate-specific antigen (PSA) levels following radical prostatectomy.
Eligibility Criteria
Conditions for Patient Eligibility:
The patient on entry will have no clinical evidence of disease by physical exam or by imaging studies. A positive ProstaScint scan alone without a confirmatory biopsy must not be used to exclude a patient. Eligible patients will be those who have undergone a radical prostatectomy (either retropubic or perineal) and pelvic lymphadenectomy (either open or laparoscopic) for carcinoma of the prostate, pathologic stage T3N0, or pT2 pN0 with positive inked resection margin, at least 12 weeks prior to study entry.
Pathological T2 patients without positive margins, who are also pathologic N0 with prostatic fossa/anastamosis biopsy at the time of rising PSA documenting recurrent cancer, are eligible.
At entry, the PSA must be between 0.2 and 4.0ng/ml, inclusive.
A post-prostatectomy radioisotopic bone scan which was done within 16 weeks prior to entry must reveal no evidence of metastatic disease.
Patient must be evaluated by both the radiation oncologist and the urologist prior to entry and judged to be a suitable candidate for radiation and hormonal therapy.
Patient must have Karnofsky performance status >= 80.
Patients must have a life expectancy in excess of 10 years.
Patients must have, within 6 weeks prior to entry, a hemoglobin (Hgb) of >=10 gm, a white blood cell (WBC) count of >= 4000 cells/ml3, a platelet count of >= 100,000 cells/ml3, a serum bilirubin <= the institutional upper limit of normal, a serum serum glutamic-oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) of <= 2.5 times the institutional upper limit of normal, and a serum creatinine of <= 2.0 times the institutional upper limit of normal.
A post-prostatectomy pelvic computerized tomography (CT) scan, within 16 weeks prior to randomization, must reveal no evidence of metastatic disease.
Patients must sign a study-specific informed consent form.
Patients with prior invasive cancers are eligible if disease free for at least 5 years; prior or concurrent basal or squamous cell skin cancer is eligible.
Conditions for Patient Ineligibility:
Pathologic stage T2 (without positive inked resection margin) or less except as stated in Section 3.1.1.1.
Pathologic lymph node stage of pN1 or greater.
An entry serum PSA of > 4.0ng/ml.
Patients with persistant urinary extravasation after prostatectomy.
Patients who have been previously treated with any hormonal therapy after prostatectomy.
Patients who have previously been treated with radiation therapy or biologic therapy for prostate cancer.
Karnofsky performance status < 80.
Treatment start > 4 weeks after randomization.
Prior chemotherapy for any reason.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 233 Locations for this study
Birmingham Alabama, 35294, United States
Huntsville Alabama, 35801, United States
Huntsville Alabama, 35807, United States
Mobile Alabama, 36688, United States
Montgomery Alabama, 36106, United States
Tuscaloosa Alabama, 35401, United States
Phoenix Arizona, 85013, United States
Concord California, 94524, United States
Duarte California, 91010, United States
Fresno California, 93720, United States
Fresno California, 93729, United States
Greenbrae California, 94904, United States
Loma Linda California, 92354, United States
Long Beach California, 90822, United States
Los Angeles California, 90025, United States
Los Angeles California, 90033, United States
Oakland California, 94609, United States
Pasadena California, 91105, United States
Pomona California, 91767, United States
Sacramento California, 95816, United States
San Diego California, 92101, United States
San Francisco California, 94143, United States
San Jose California, 95128, United States
Santa Rosa California, 95403, United States
Travis Air Force Base California, 94535, United States
Colorado Springs Colorado, 80909, United States
Denver Colorado, 80010, United States
Grand Junction Colorado, 81502, United States
New Haven Connecticut, 06511, United States
Wilmington Delaware, 19899, United States
Gainesville Florida, 32610, United States
Jacksonville Florida, 32207, United States
Melbourne Florida, 32901, United States
Miami Beach Florida, 33140, United States
Miami Florida, 33125, United States
Miami Florida, 33136, United States
Miami Florida, 33256, United States
Orlando Florida, 32806, United States
Panama City Florida, 32401, United States
Panama City Florida, 32405, United States
Sarasota Florida, 34233, United States
Tallahassee Florida, 32308, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Atlanta Georgia, 30342, United States
Columbus Georgia, 31901, United States
Rome Georgia, 30165, United States
Honolulu Hawaii, 96813, United States
Arlington Heights Illinois, 60005, United States
Chicago Illinois, 60611, United States
Decatur Illinois, 62526, United States
Harvey Illinois, 60426, United States
Maywood Illinois, 60153, United States
Park Ridge Illinois, 60068, United States
Peoria Illinois, 61636, United States
Anderson Indiana, 46016, United States
Bloomington Indiana, 47402, United States
Indianapolis Indiana, 46202, United States
Indianapolis Indiana, 46206, United States
Indianapolis Indiana, 46219, United States
Muncie Indiana, 47303, United States
South Bend Indiana, 46601, United States
Dubuque Iowa, 52001, United States
Lexington Kentucky, 40503, United States
Lexington Kentucky, 40504, United States
Lexington Kentucky, 40536, United States
Louisville Kentucky, 40202, United States
Louisville Kentucky, 40215, United States
Madisonville Kentucky, 42431, United States
Baton Rouge Louisiana, 70809, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70121, United States
Portland Maine, 04102, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21204, United States
Baltimore Maryland, 21215, United States
Baltimore Maryland, 21215, United States
Baltimore Maryland, 21231, United States
Salisbury Maryland, 21801, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02115, United States
Hyannis Massachusetts, 02601, United States
Jamaica Plain Massachusetts, 02130, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Flint Michigan, 48503, United States
Flint Michigan, 48532, United States
Kalamazoo Michigan, 49007, United States
Marquette Michigan, 49855, United States
Midland Michigan, 48670, United States
Royal Oak Michigan, 48073, United States
Royal Oak Michigan, 48073, United States
Troy Michigan, 48098, United States
Rochester Minnesota, 55905, United States
Saint Louis Park Minnesota, 55416, United States
Columbia Missouri, 65203, United States
Kansas City Missouri, 64131, United States
Saint Louis Missouri, 63108, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65807, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
Omaha Nebraska, 68106, United States
Omaha Nebraska, 68114, United States
Omaha Nebraska, 68198, United States
Las Vegas Nevada, 89106, United States
Lebanon New Hampshire, 03756, United States
Manchester New Hampshire, 03103, United States
Camden New Jersey, 01803, United States
East Orange New Jersey, 07019, United States
Edison New Jersey, 08818, United States
Elizabeth New Jersey, 07201, United States
Long Branch New Jersey, 07740, United States
Millville New Jersey, 08332, United States
Mount Holly New Jersey, 08060, United States
New Brunswick New Jersey, 38103, United States
Newark New Jersey, 07112, United States
Pomona New Jersey, 08240, United States
Ridgewood New Jersey, 07450, United States
Somerville New Jersey, 08876, United States
Toms River New Jersey, 08755, United States
Trenton New Jersey, 08618, United States
Trenton New Jersey, 08629, United States
Warren New Jersey, 07059, United States
Albuquerque New Mexico, 87109, United States
Albany New York, 12208, United States
Brooklyn New York, 11203, United States
Brooklyn New York, 11215, United States
Buffalo New York, 14263, United States
Clifton Springs New York, 14432, United States
Manhasset New York, 11030, United States
New York New York, 10032, United States
Plattsburgh New York, 12901, United States
Poughkeepsie New York, 12601, United States
Rochester New York, 14642, United States
Syracuse New York, 13217, United States
Yonkers New York, 10701, United States
Chapel Hill North Carolina, 27599, United States
Concord North Carolina, 28025, United States
Greenville North Carolina, 27858, United States
Winston-Salem North Carolina, 27104, United States
Winston-Salem North Carolina, 27157, United States
Minot North Dakota, 58701, United States
Akron Ohio, 44302, United States
Akron Ohio, 44304, United States
Cincinnati Ohio, 45219, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44106, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43206, United States
Columbus Ohio, 43210, United States
Kettering Ohio, 45429, United States
Oklahoma City Oklahoma, 73101, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74104, United States
Tulsa Oklahoma, 74136, United States
Portland Oregon, 97225, United States
Allentown Pennsylvania, 18105, United States
Bethlehem Pennsylvania, 18015, United States
Danville Pennsylvania, 17822, United States
Darby Pennsylvania, 19023, United States
Drexel Hill Pennsylvania, 19026, United States
East Stroudsburg Pennsylvania, 18301, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19104, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Philadelphia Pennsylvania, 19141, United States
Pittsburgh Pennsylvania, 15213, United States
Pittsburgh Pennsylvania, 15219, United States
Pittsburgh Pennsylvania, 15224, United States
Reading Pennsylvania, 19612, United States
Scranton Pennsylvania, 18501, United States
Wilkes-Barre Pennsylvania, 18764, United States
York Pennsylvania, 17315, United States
Providence Rhode Island, 02908, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
Rapid City South Dakota, 57709, United States
Jackson Tennessee, 38301, United States
Memphis Tennessee, 38103, United States
Nashville Tennessee, 37232, United States
Amarillo Texas, 79106, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
Lackland Air Force Base Texas, 78236, United States
Lubbock Texas, 79410, United States
Pasadena Texas, 77504, United States
Saint George Utah, 84770, United States
Salt Lake City Utah, 84132, United States
Salt Lake City Utah, 84143, United States
Bennington Vermont, 05201, United States
Burlington Vermont, 05401, United States
Charlottesville Virginia, 22908, United States
Harrisonburg Virginia, 22801, United States
Portsmouth Virginia, 23708, United States
Richmond Virginia, 23226, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98111, United States
Spokane Washington, 99210, United States
Yakima Washington, 98902, United States
Wheeling West Virginia, 26003, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54307, United States
La Crosse Wisconsin, 54601, United States
Madison Wisconsin, 53713, United States
Madison Wisconsin, 53792, United States
Marshfield Wisconsin, 54449, United States
Menomonee Falls Wisconsin, 53051, United States
Milwaukee Wisconsin, 53211, United States
Milwaukee Wisconsin, 53215, United States
Milwaukee Wisconsin, 53226, United States
Milwaukee Wisconsin, 53295, United States
Racine Wisconsin, 53405, United States
Waukesha Wisconsin, 53188, United States
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Saint John New Brunswick, E2L 4, Canada
St. Johns Newfoundland and Labrador, A1B 3, Canada
Halifax Nova Scotia, B3H 1, Canada
Hamilton Ontario, L8V 5, Canada
Kingston Ontario, K7L 5, Canada
London Ontario, N6A 4, Canada
Ottawa Ontario, K1H 1, Canada
Sudbury Ontario, P3E 5, Canada
Thunder Bay Ontario, P7A 7, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Fleurimont Quebec, J1H 5, Canada
Montreal Quebec, H2L 4, Canada
Montreal Quebec, H2W 1, Canada
Quebec City Quebec, G1R 2, Canada
Regina Saskatchewan, S4T 7, Canada
Saskatoon Saskatchewan, S7N 4, Canada
How clear is this clinincal trial information?