{"registry": "ISRCTN", "registryId": "ISRCTN01534787", "source": "https://www.isrctn.com/ISRCTN01534787", "apiSource": "https://www.isrctn.com/api/trial/ISRCTN01534787/format/default", "fetchedAt": "2026-10-07T17:01:30.283454Z", "license": "CC BY 4.0", "licenseSource": "https://www.isrctn.com/page/faqs#licence-to-post", "study": {"title": "A randomised trial comparing hormonal treatment versus combination of hormonal treatment and radiotherapy in locally advanced prostate cancer", "scientificTitle": "Randomised trial of locally advanced/aggressive prostatic cancer: T3 diff grad 1-3, T1b - T2 diff grad 2-3 (optional), NO, MO antiandrogen treatment with or without radiotherapy", "acronym": "SPCG-7/SFUO-3", "hypothesis": "To evaluate if the addition of radiotherapy improves the outcome in hormonally-treated, locally advanced/aggressive, node-negative and non-metastasised prostatic cancer.", "primaryOutcome": "To evaluate if cause-specific seven-year survival can be improved in patients treated with a combination of radiotherapy and anti-androgen as compared to anti-androgen therapy only.\n\nPrimary and secondary endpoints were planned to be analysed after seven years.", "secondaryOutcome": "1. To evaluate:\n1.1. Time to biochemical progression (PSA)\n1.2. Time to symptoms related to local progression\n1.3. Time to symptoms related to distant progression\n2. To evaluate quality of life (QOL) with special focus on sexual function, urinary and gastrointestinal morbidity\n\nPrimary and secondary endpoints were planned to be analysed after seven years.", "intervention": "\n\tAfter randomisation all patients were treated with total androgen blockade (TAB) with an LHRH-agonist (Procren Depot; Abbott), for three months in combination with an oral anti-androgen (AA) Eulexin (Schering-Plough) 250 mg x 3. Thereafter all patients continued on the anti-androgen alone, T Eulexin 250 mg x 3 daily, continuously until progression. After three months patients in the Radiotherapy+Hormone arm started radiotherapy whereas patients in the Hormone-only arm had no local treatment. Minimal radiation dose to the prostate will be 70 Gy and the seminal vesicles will be included up to a minimum dose of 50 Gy.\n\tDrug\n\tNot Specified\n\tLeuprolide (Procren Depot), flutamide (Eulexin)\n      ", "condition": "\n\tLocal or locally advanced prostate cancer, pN0, M0\n\tCancer\n\tMalignant neoplasm of prostate\n      ", "studyDesign": "A randomised open, comparative, parallel design trial", "overallEndDate": "2002-12-30T00:00:00.000Z", "clinicalTrialsGovNumber": "", "lastUpdated": "2009-04-08T00:00:00.000Z", "eligibility": {"inclusion": "1. Men less than 76 years of age and, as judged by the doctor, a life expectancy of less than 10 years (except for cancer) at time of randomisation with performance status World Health Organization (WHO) 0 - 2\n2. Patients with histologically/cytologically verified prostatic cancer\n3. Patients with prostatic cancer of clinical category T1b-T2; G2-G3 and T3; G1-G3 according to the TNM classification system of 1992. Inclusion of patients with T1b-T2; G3 and T2; G2 is optional.\n4. The patients should have no evidence of metastases by clinical investigation, bone scan or pulmonary x-ray\n5. Patients should be lymph node negative\n6. Patients should be suitable for radiotherapy and anti-androgen treatment", "exclusion": "1. Patients who earlier have undergone any other treatment against prostatic cancer except transurethral resection of the prostate (TUR-P)\n2. Patients with a prostate specific antigen (PSA) greater than 70 ng/ml\n3. Patients unable to cooperate or suffering from any other form of disease that would interfere with the planned treatment (e.g. colitis)\n4. Liver function that would interfere with the anti-androgen treatment (a bilirubin and/or alanine aminotransferase [ALAT] value above the upper normal limit)\n5. Patients with previous diagnosis of other malignant disease. Exceptions could be made for basal cell carcinoma of the skin or progression free survival at least 10 years after any previous tumour (this requires discussion with the study co-ordinator).", "ageRange": "Adult", "gender": "Male", "participantType": "Patient"}, "recruitment": {"recruitmentStart": "1996-02-27T00:00:00.000Z", "recruitmentEnd": "2002-12-30T00:00:00.000Z", "recruitmentStatusOverride": "", "recruitmentStartStatusOverride": "", "targetEnrolment": "880", "totalFinalEnrolment": ""}, "countries": ["Denmark", "Norway", "Sweden"], "locations": [{"name": "Department of Radiation Sciences, Oncology", "city": "Umeå", "state": "", "country": "Sweden", "zip": "90185"}], "sponsors": [{"organisation": "Scandinavian Prostate Cancer Group (SPCG) (Sweden) ", "sponsorType": "Research organisation"}], "funders": [{"name": "Scandinavian Prostate Cancer Group (SPCG) (Sweden) - after receiving an unrestricted grant from Schering-Plough Inc. and Abbott Scandinavia Inc."}, {"name": "Nordic Cancer Union (Norway)"}]}, "studySha256": "3122cf1a73e6f67b699bfb71f27cf2e46f1424259e755d6439fe76d412c49408"}