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A randomised trial comparing hormonal treatment versus combination of hormonal treatment and radiotherapy in locally advanced prostate cancer
ISRCTN ISRCTN01534787
DOI 10.1186/ISRCTN01534787
ClinicalTrials.gov identifier
EudraCT number
Public title A randomised trial comparing hormonal treatment versus combination of hormonal treatment and radiotherapy in locally advanced prostate cancer
Scientific title 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
Serial number at source Version 1996 01 09
Study hypothesis To evaluate if the addition of radiotherapy improves the outcome in hormonally-treated, locally advanced/aggressive, node-negative and non-metastasised prostatic cancer.
Lay summary
Ethics approval Ethics approval received from Umeå University, Medical Faculty Ethical Committee in 1995 (ref: paragraph 247/95; diary no. 95-179).
Study design A randomised open, comparative, parallel design trial
Countries of recruitment Denmark, Norway, Sweden
Disease/condition/study domain Local or locally advanced prostate cancer, pN0, M0
Participants - inclusion criteria 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
2. Patients with histologically/cytologically verified prostatic cancer
3. 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.
4. The patients should have no evidence of metastases by clinical investigation, bone scan or pulmonary x-ray
5. Patients should be lymph node negative
6. Patients should be suitable for radiotherapy and anti-androgen treatment
Participants - exclusion criteria 1. Patients who earlier have undergone any other treatment against prostatic cancer except transurethral resection of the prostate (TUR-P)
2. Patients with a prostate specific antigen (PSA) greater than 70 ng/ml
3. Patients unable to cooperate or suffering from any other form of disease that would interfere with the planned treatment (e.g. colitis)
4. Liver function that would interfere with the anti-androgen treatment (a bilirubin and/or alanine aminotransferase [ALAT] value above the upper normal limit)
5. 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).
Anticipated start date 27/02/1996
Anticipated end date 30/12/2002
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet (only in Swedish, Norwegian and Danish)
Target number of participants Initilly 660, later enlarged to 880, due to fewer events than expected
Interventions After 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.
Primary outcome measure(s) 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.

Primary and secondary endpoints were planned to be analysed after seven years.
Secondary outcome measure(s) 1. To evaluate:
1.1. Time to biochemical progression (PSA)
1.2. Time to symptoms related to local progression
1.3. Time to symptoms related to distant progression
2. To evaluate quality of life (QOL) with special focus on sexual function, urinary and gastrointestinal morbidity

Primary and secondary endpoints were planned to be analysed after seven years.
Sources of funding 1. Scandinavian Prostate Cancer Group (SPCG) (Sweden) - after receiving an unrestricted grant from Schering-Plough Inc. and Abbott Scandinavia Inc.
2. Nordic Cancer Union (Norway)
Trial website
Publications 1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19091394
2. 2009 four-year follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/19286422
Contact name Prof  Anders  Widmark
  Address Department of Radiation Sciences, Oncology
Umeå University, Hospital
  City/town Umeå
  Zip/Postcode 90185
  Country Sweden
  Email Anders.Widmark@onkologi.umu.se
Sponsor Scandinavian Prostate Cancer Group (SPCG) (Sweden)
  Address c/o P.O.Hedlund
Skogsstigen 22
131 42 Nacka
  City/town Stockholm
  Zip/Postcode 103 42
  Country Sweden
  Sponsor website: http://www.spcg.se
Date applied 29/05/2008
Last edited 08/04/2009
Date ISRCTN assigned 13/06/2008
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