A randomised trial comparing hormonal treatment versus combination of hormonal treatment and radiotherapy in locally advanced prostate cancer

ISRCTN	ISRCTN01534787
DOI	https://doi.org/10.1186/ISRCTN01534787
Protocol serial number	Version 1996 01 09
Sponsor	Scandinavian Prostate Cancer Group (SPCG) (Sweden)
Funders	Scandinavian Prostate Cancer Group (SPCG) (Sweden) - after receiving an unrestricted grant from Schering-Plough Inc. and Abbott Scandinavia Inc., Nordic Cancer Union (Norway)

Submission date: 29/05/2008
Registration date: 13/06/2008
Last edited: 08/04/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Anders Widmark
Scientific

Department of Radiation Sciences, Oncology
Umeå University, Hospital
Umeå
90185
Sweden

Email	Anders.Widmark@onkologi.umu.se

Study information

Primary study design	Interventional
Study design	A randomised open, comparative, parallel design trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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 acronym	SPCG-7/SFUO-3
Study objectives	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(s)	Ethics approval received from Umeå University, Medical Faculty Ethical Committee in 1995 (ref: paragraph 247/95; diary no. 95-179).
Health condition(s) or problem(s) studied	Local or locally advanced prostate cancer, pN0, M0
Intervention	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	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Leuprolide (Procren Depot), flutamide (Eulexin)
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.
Key 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.
Completion date	30/12/2002

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	880
Key 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
Key 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).
Date of first enrolment	27/02/1996
Date of final enrolment	30/12/2002

Locations

Countries of recruitment

Denmark
Norway
Sweden

Study participating centre

Department of Radiation Sciences, Oncology

Umeå
90185
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	24/01/2009		Yes	No
Results article	four-year follow-up results	01/04/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes