Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Anders Widmark


Contact details

Department of Radiation Sciences
Umeå University

Additional identifiers

EudraCT number number

Protocol/serial number

Version 1996 01 09

Study information

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



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.

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

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet (only in Swedish, Norwegian and Danish)


Local or locally advanced prostate cancer, pN0, M0


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.

Intervention type



Not Specified

Drug names

Leuprolide (Procren Depot), flutamide (Eulexin)

Primary outcome measure

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 measures

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.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants

Initilly 660, later enlarged to 880, due to fewer events than expected

Participant 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).

Recruitment start date


Recruitment end date



Countries of recruitment

Denmark, Norway, Sweden

Trial participating centre

Department of Radiation Sciences, Oncology

Sponsor information


Scandinavian Prostate Cancer Group (SPCG) (Sweden)

Sponsor details

c/o P.O.Hedlund
Skogsstigen 22
131 42 Nacka
103 42

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

Scandinavian Prostate Cancer Group (SPCG) (Sweden) - after receiving an unrestricted grant from Schering-Plough Inc. and Abbott Scandinavia Inc.

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Nordic Cancer Union (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2009 results in
2. 2009 four-year follow-up results in

Publication citations

  1. Widmark A, Klepp O, Solberg A, Damber JE, Angelsen A, Fransson P, Lund JA, Tasdemir I, Hoyer M, Wiklund F, Fosså SD, , , Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial., Lancet, 2009, 373, 9660, 301-308, doi: 10.1016/S0140-6736(08)61815-2.

  2. Fransson P, Lund JA, Damber JE, Klepp O, Wiklund F, Fosså S, Widmark A, , , Quality of life in patients with locally advanced prostate cancer given endocrine treatment with or without radiotherapy: 4-year follow-up of SPCG-7/SFUO-3, an open-label, randomised, phase III trial., Lancet Oncol., 2009, 10, 4, 370-380, doi: 10.1016/S1470-2045(09)70027-0.

Additional files

Editorial Notes