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

Completed

• Conditions: ocal or locally advanced prostate cancer, pN0, M0; Cancer; Malignant neoplasm of prostate

• Registration Number: ISRCTN76301727
• Lead Sponsor: Scandinavian Prostate Cancer Group (SPCG) (Sweden)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 200

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified