The incidence of residual prostate cancer in patients included in a randomised trial comparing hormonal treatment versus combination of hormonal treatment and radiotherapy in locally advanced prostate cancer

ISRCTN	ISRCTN76301727
DOI	https://doi.org/10.1186/ISRCTN76301727
Protocol serial number	N/A
Sponsor	Scandinavian Prostate Cancer Group (SPCG) (Sweden)
Funders	The Nordic Cancer Union (Norway), The Norwegian Cancer Society (Norway)

Submission date: 31/08/2009
Registration date: 28/09/2009
Last edited: 28/09/2009

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Arne Solberg
Scientific

St. Olavs Hospital
Kreftavdelingen
Olav Kyrresgt. 17.
Trondheim
7006
Norway

Study information

Primary study design	Interventional
Study design	Side-study to a randomised open comparative parallel-design trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Post-treatment prostatic biopsies after anti-androgen treatment with or without radiotherapy of locally advanced prostatic cancer: side study of the SPCG-7/SFUO-3 randomised trial
Study objectives	The incidence of residual local tumour in prostatic biopsies from patients with locally advanced prostatic cancer following 3 years (and 6 months) hormonal treatment with flutamide, is not statistically different from the incidence seen in patients treated with radiotherapy and flutamide. Please note that this is a side-study to a previously registered trial, which can be found under ISRCTN01534787 - "A randomised trial comparing hormonal treatment versus combination of hormonal treatment and radiotherapy in locally advanced prostate cancer [SPCG-7/SFUO-3 trial]" (http://www.controlled-trials.com/ISRCTN01534787).
Ethics approval(s)	The Regional Committee for Medical and Health Research Ethics of Middle-Norway approved on the 15th August 2000 (ref: 112-2000)
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 and 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. Prostate biopsies should be taken at the 3 year (and 6 months) follow up visit.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Flutamide, Procren Depot, T Eulexin
Primary outcome measure(s)	To compare the incidence of residual local tumour following hormonal treatment with the analogue incidence rate after the combination of hormonal treatment and radiotherapy. The incidence of residual prostate cancer was measured by post-treatment prostate biopsies performed 3 years plus/minus 6 months from randomisation in the SPCG-7/SFUO-3 trial.
Key secondary outcome measure(s)	1. To study the prognostic implication of post-treatment residual tumour in patients included in SPCG-7. The prognostic implications of residual cancer were measured with respect to the following events: 1.1. PSA-recurrence 1.2. Local recurrence (clinical) 1.3. Distant recurrence (metastasis) 1.4. Death These were measured as follows: All patients were followed by the the treating physician every 6 months from randomisation in the SPCG-7/SFUO-3 trial, and data with respect to these events was registered in the SPCG-7/SFUO-3 case report file (CRF) on every visit. In patients who had died, the cause of death was registered in the CRF. By the end of February 2008 survival status was controlled against the nation-wide population registries in Sweden and Norway. 2. To obtain a storage of post-treatment biopsies for the possibility of further characterisation of residing tumour cells by means of immunohistochemical staining methods for potential prognostic markers. A storage of post-treatment prostate biopsies for the possibility of further characterisation of residing tumour cells was obtained at the time of biopsy (3 years plus/minus 6 months from randomisation in the SPCG-7/SFUO-3 trial).
Completion date	31/10/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	200
Key inclusion criteria	1. Patients must have been included in the SPCG-7/SFUO-3 study with the following inclusion criteria: 1.1. 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 1.2. Patients with histologically/cytologically verified prostatic cancer 1.3. 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. 1.4. The patients should have no evidence of metastases by clinical investigation, bone scan or pulmonary x-ray 1.5. Patients should be lymph node negative 1.6. Patients should be suitable for radiotherapy and anti-androgen treatment 2. Written patient informed consent 3. WHO performance status (Zubrod) 0 - 1 4. No medical hazard connected with the previous or the planned biopsy-procedure
Key exclusion criteria	1. Patient refusal 2. Medical hazard during previous prostatic biopsy procedures 3. Medical hazard expected during the planned biopsy procedure 4. Serious urine outlet-problems or risk of infections or haemorrhage
Date of first enrolment	01/03/2001
Date of final enrolment	31/10/2005

Locations

Countries of recruitment

Norway
Sweden

Study participating centre

St. Olavs Hospital

Trondheim
7006
Norway

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes