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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN76301727

Enrollment

200

Registered

2009-09-28

Start date

2001-03-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local or locally advanced prostate cancer, pN0, M0 Cancer Malignant neoplasm of prostate

Interventions

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,

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Countries

Norway, Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026