Condition category
Cancer
Date applied
31/08/2009
Date assigned
28/09/2009
Last edited
28/09/2009
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

Dr Arne Solberg

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

The Regional Committee for Medical and Health Research Ethics of Middle-Norway approved on the 15th August 2000 (ref: 112-2000)

Study design

Side-study to 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 and Norwegian)

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 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 names

Flutamide, Procren Depot, T Eulexin

Primary outcome measures

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.

Secondary outcome measures

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).

Overall trial start date

01/03/2001

Overall trial end date

31/10/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

200 patients

Participant 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

Recruitment start date

01/03/2001

Recruitment end date

31/10/2005

Locations

Countries of recruitment

Norway, Sweden

Trial participating centre

St. Olavs Hospital
Trondheim
7006
Norway

Sponsor information

Organisation

Scandinavian Prostate Cancer Group (SPCG) (Sweden)

Sponsor details

P.O. Hedlund
Skogstien 22
131 42 Nacka
Stockholm
103 42
Sweden
+46 (0)87 167 659
spcg@spcg.no

Sponsor type

Research organisation

Website

http://www.spcg.no/

Funders

Funder type

Charity

Funder name

The Nordic Cancer Union (Norway)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Norwegian Cancer Society (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

Publication citations

Additional files

Editorial Notes