Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-01-24 @ 8:40 PM
Study NCT ID:
NCT00002703
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 390}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-08-31', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-09-01', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'stage I prostate cancer', 'stage IIB prostate cancer', 'stage IIA prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '21470787', 'type': 'RESULT', 'citation': 'Coen JJ, Zietman AL, Rossi CJ, Grocela JA, Efstathiou JA, Yan Y, Shipley WU. Comparison of high-dose proton radiotherapy and brachytherapy in localized prostate cancer: a case-matched analysis. Int J Radiat Oncol Biol Phys. 2012 Jan 1;82(1):e25-31. doi: 10.1016/j.ijrobp.2011.01.039. Epub 2011 Apr 4.'}, {'pmid': '20207497', 'type': 'RESULT', 'citation': 'Nguyen PL, Chen RC, Hoffman KE, Trofimov A, Efstathiou JA, Coen JJ, Shipley WU, Zietman AL, Talcott JA. Rectal dose-volume histogram parameters are associated with long-term patient-reported gastrointestinal quality of life after conventional and high-dose radiation for prostate cancer: a subgroup analysis of a randomized trial. Int J Radiat Oncol Biol Phys. 2010 Nov 15;78(4):1081-5. doi: 10.1016/j.ijrobp.2009.09.015. Epub 2010 Mar 6.'}, {'pmid': '20124169', 'type': 'RESULT', 'citation': 'Zietman AL, Bae K, Slater JD, Shipley WU, Efstathiou JA, Coen JJ, Bush DA, Lunt M, Spiegel DY, Skowronski R, Jabola BR, Rossi CJ. Randomized trial comparing conventional-dose with high-dose conformal radiation therapy in early-stage adenocarcinoma of the prostate: long-term results from proton radiation oncology group/american college of radiology 95-09. J Clin Oncol. 2010 Mar 1;28(7):1106-11. doi: 10.1200/JCO.2009.25.8475. Epub 2010 Feb 1.'}, {'type': 'RESULT', 'citation': 'Rossi CJ, Zietman AL, DeSilvio M, et al.: A randomized trial comparing conventional dose (70.2GyE) and high-dose (79.2GyE) conformal radiation in early stage adenocarcinoma of the prostate: results of an interim analysis of PROG 95-09. [Abstract] American Society of Clinical Oncology 2005 Prostate Cancer Symposium, 17-19 February 2005, Orlando, Florida. A-58, 2005.'}, {'pmid': '16160131', 'type': 'RESULT', 'citation': 'Zietman AL, DeSilvio ML, Slater JD, Rossi CJ Jr, Miller DW, Adams JA, Shipley WU. Comparison of conventional-dose vs high-dose conformal radiation therapy in clinically localized adenocarcinoma of the prostate: a randomized controlled trial. JAMA. 2005 Sep 14;294(10):1233-9. doi: 10.1001/jama.294.10.1233.'}, {'type': 'RESULT', 'citation': 'Zietman AL, DeSilvio M, Slater JD, et al.: A randomized trial comparing conventional dose (70.2GyE) and high-dose (79. 2GyE) conformal radiation in early stage adenocarcinoma of the prostate: results of an interim analysis of PROG 95-09. [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-4, S131, 2004.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radiation therapy uses high energy x-rays to damage tumor cells.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of conventional radiation therapy with high-dose radiation therapy in treating men with stage I or stage II prostate cancer.', 'detailedDescription': 'OBJECTIVES: I. Determine whether high-dose radiotherapy using conformal photons with a proton boost produces a 20% increase in the proportion of Stage I/II prostate cancer free from local failure and biochemical relapse at 5 years when compared to results of conventional-dose radiotherapy. II. Determine whether high-dose radiotherapy produces a 33% reduction in the cumulative incidence of a rising PSA (second hormone failure) following hormone therapy given at the time of first PSA/clinical failure when compared with conventional-dose radiotherapy. IV. Assess the relative rectal, bladder, and sexual morbidity of conformal photon doses of 70.2 and 79.2 Gy in these patients. V. Collect, in a prospective manner, paraffin biopsy blocks for subsequent analysis of emerging molecular pathologic predictors of outcome in three patients.\n\nOUTLINE: Randomized study. Arm I: Radiotherapy. Boost to the prostate using high-LET protons followed by irradiation of the prostate, periprostatic tissues, and seminal vesicles using conformal photons with energies greater than 6 MV. Conventional dose. Arm II: Radiotherapy. As in Arm I. High dose.\n\nPROJECTED ACCRUAL: There will be 390 patients accrued into this study over 3 years. An additional 3.5 years will be required for follow-up.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Primary tumor confined to prostate TNM clinical Stages T1b-c or T2a-b No T1a No T1b-c tumor with Gleason grade 1-2/5 No Gleason grade 1-2/5 and PSA less than 4 ng/mL Nodes negative on imaging (Nx) or by surgical sampling (N0) PSA no greater than 15 ng/mL Treatment must begin within 28 days after randomization\n\nPATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 70%-100% Life expectancy: Greater than 10 years Other: No major medical or psychiatric illness that precludes protocol entry No prior or concurrent second malignancy within 5 years except basal cell skin cancer\n\nPRIOR CONCURRENT THERAPY: No prior treatment for prostate cancer'}, 'identificationModule': {'nctId': 'NCT00002703', 'briefTitle': 'Radiation Therapy in Treating Patients With Stage I or Stage II Prostate Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A PHASE III TRIAL EMPLOYING CONFORMAL PHOTONS WITH PROTON BOOST IN EARLY STAGE PROSTATE CANCER: CONVENTIONAL DOSE COMPARED TO HIGH DOSE IRRADIATION', 'orgStudyIdInfo': {'id': 'CDR0000064503'}, 'secondaryIdInfos': [{'id': 'PROG-9509'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'high-LET heavy ion therapy', 'type': 'RADIATION'}, {'name': 'low-LET photon therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital Cancer Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Anthony L. Zietman, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Proton Radiation Oncology Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}