Condition category
Cancer
Date applied
29/05/2008
Date assigned
13/06/2008
Last edited
08/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Anders Widmark

ORCID ID

Contact details

Department of Radiation Sciences
Oncology
Umeå University
Hospital
Umeå
90185
Sweden
Anders.Widmark@onkologi.umu.se

Additional identifiers

EudraCT number

ClinicalTrials.gov 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

Acronym

SPCG-7/SFUO-3

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

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)

Condition

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 names

Leuprolide (Procren Depot), flutamide (Eulexin)

Primary outcome measures

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

27/02/1996

Overall trial end date

30/12/2002

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Male

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

27/02/1996

Recruitment end date

30/12/2002

Locations

Countries of recruitment

Denmark, Norway, Sweden

Trial participating centre

Department of Radiation Sciences, Oncology
Umeå
90185
Sweden

Sponsor information

Organisation

Scandinavian Prostate Cancer Group (SPCG) (Sweden)

Sponsor details

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

Sponsor type

Research organisation

Website

http://www.spcg.se

Funders

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

Location

Funder name

Nordic Cancer Union (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

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

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