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 @ 4:32 AM
Ignite Modification Date:
2025-12-25 @ 4:32 AM
NCT ID:
NCT02004418
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Biopsy proven prostate cancer with an intermediate risk feature defined as
1. Gleason score 7, PSA \<20, T1-T2C or
2. Gleason score 6, PSA 10-20, T1-T2C or
3. Gleason Score 6 or 7, PSA \<20, T2C
3. Localized disease based on staging investigations including bone scan, CT abdomen and pelvis, and any other clinically indicated staging investigations
4. Eligible for curative intent external beam radiotherapy
5. Able and willing to follow instructions and comply with protocol
6. Provide written informed consent prior to participation in the study
7. Karnofsky Performance Scale Score 70-100
Exclusion Criteria:
1. Have had a 11C-Choline PET scan performed within 4 weeks after any biopsies of the prostate (due to concern that acute post biopsy intraprostatic changes may affect scan accuracy)
2. BMI ≥ 30
3. The presence of a hip prosthesis
4. Bilirubin ≥ 20 µmol/L
5. AST or ALT ≥ 5 times the upper limits of normal
6. Serious medical conditions which may prevent a patient from tolerating therapy such as: congestive heart failure, unstable angina, unstable ventricular arrhythmia, uncontrolled psychiatric conditions, serious infections and/or uncontrolled diabetes.
7. Metastatic disease
8. Prostate cancer with only low risk features or any high risk feature with a PSA ≥20 or T3 disease
9. A history of previous carcinoma except for basal cell carcinoma
10. Age \< 18 years
11. Prior treatment with hormonal therapy
12. AUA prostate symptom score \> 20
13. Crohn's disease or ulcerative colitis
14. Patient is unable to comply adequately iwth bowel or bladder prep during CT simulation
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02004418
Study Brief:
Protocol Section:
NCT02004418