Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT00193856
Eligibility Criteria:
Inclusion Criteria:
* Histological confirmation of adenocarcinoma of the prostate in the three months prior to randomisation
* Gleason primary and secondary pattern reported. If the volume of tumour in biopsies is too small for the pathologist to allocate a secondary pattern, the primary pattern alone is sufficient.
* Primary tumour stage T2b - 4 (UICC 2002), or T2a providing biopsies demonstrate Gleason score 7 or more, and presenting PSA 10 or more
* PSA value obtained within one month of randomisation
* No evidence of lymphatic or haematogenous metastases, as determined by negative chest x-ray, CT scan of abdomen and pelvis, and bone scan in the 3 months prior to randomisation
* ECOG performance status 0 - 1
* No concurrent medical conditions likely to significantly reduce prospects of 5 year survival
* Patient accessible to follow up at intervals specified in protocol
* Written informed consent given (signed by both patient and investigator prior to randomisation)
Exclusion Criteria:
* Previous or concurrent malignancy within previous 5 years except for non-melanomatous skin cancer
* Prostatectomy
* Prior pelvic radiotherapy
* Prior hormone treatment for prostate cancer
* Inability to complete self administered QOL questionnaire
* Prior bisphosphonate therapy
* Serum creatinine \> 2 x ULN
* Osteoporosis resulting in \>30% loss in vertebral height in one or more thoraco-lumbar vertebrae
* Liver disease resulting in ALT or AST levels \>3 x ULN
* Prolonged continuous glucocorticoid therapy \> 10 mg/day of prednisone equivalent (\>6 months)
* Current treatment with bisphosphonate
* Inability to attend for follow-up at the Investigator's clinic
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00193856
Study Brief:
Protocol Section:
NCT00193856