Eligibility Module

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: 2025-12-25 @ 3:08 AM
Ignite Modification Date: 2025-12-25 @ 3:08 AM
NCT ID: NCT00989105
Eligibility Criteria: DISEASE CHARACTERISTICS: * Histologically confirmed prostate cancer meeting 1 of the following criteria: * Disease confined to the prostate that is to be treated with radical prostatectomy after imaging * Locally advanced disease that is to be treated with radiotherapy * Patients must agree to undergo surgical pelvic lymph node staging to assist with determination of radiation fields * Metastatic disease at initial diagnosis or recurrent or progressive disease * Patients receive standard of care PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Neutrophils ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * Serum bilirubin ≤ 1.5 times upper limit of normal (ULN) * Serum creatinine ≤ 1.5 times ULN * Must be registered with the Cancer Research UK Drug Development Office * Capable of cooperating with imaging procedure and follow-up * Fertile patients must use effective contraception during and for 6 months after completion of study therapy * Not at high medical risk because of non-malignant systemic disease, including active uncontrolled infection * No history of recent significant cardiac arrhythmia * No prior NYHA class III-IV cardiac disease or concurrent congestive heart failure * No other condition that, in the Investigator's opinion, would not make the patient a good candidate for the clinical trial PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No chemotherapy or radiotherapy prior to or within 2 weeks of study therapy * No prior major thoracic and/or abdominal surgery from which the patient has not yet recovered * No other concurrent investigational drugs * Concurrent anticancer therapy allowed
Healthy Volunteers: False
Sex: MALE
Minimum Age: 18 Years
Study: NCT00989105
Study Brief:
Protocol Section: NCT00989105