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 @ 3:37 AM
Ignite Modification Date:
2025-12-25 @ 3:37 AM
NCT ID:
NCT01578902
Eligibility Criteria:
Inclusion Criteria:
* Informed consent signed (Appendix A)
* Adult men greater than 18 years of age
* Histologically confirmed diagnosis of adenocarcinoma of the prostate (centrally reviewed).
* Clinical stage T1-T2b, Gleason Score \< 6, and PSA \< 10 ng/mL
* Less than 50% of biopsy cores +ve for cancer
* Less than 50% overall surface area involved with cancer
* Neoadjuvant hormone suppression therapy is allowed. However, PSA, must have been performed within 2 months of starting androgen suppression therapy. If androgen suppression therapy has been started LHRH agonist must be continued for a minimum of 3 months before initiation of gold fiducial marker insertion \& radiotherapy planning.
Exclusion Criteria:
* Prior pelvic radiotherapy.
* Concurrent anticoagulation medication (if it is unsafe to discontinue for gold seed insertion)
* Diagnosis of bleeding diathesis
* Presence of a hip prosthesis
* Pelvic girth \>40cm (to ensure visibility of gold seeds on electronic portal imaging device)
* Large prostate (\> 60 cm3) on imaging
* Severe lower urinary tract symptoms (International Prostate Symptom Score \> 15 or nocturia \> 3)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01578902
Study Brief:
Protocol Section:
NCT01578902