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 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT00951535
Eligibility Criteria:
Inclusion Criteria:
1. Patients undergoing a radical course of RT for high-risk disease (defined according to the National Comprehensive Cancer Network Practice Guidelines in Oncology v.1 as one or more of the NCCN high risk criteria \> or equal to T3, \> or equal to Gleason 8, PSA \> 20ng/ml)
2. Only patients requiring neo-adjuvant / adjuvant hormonal therapy will be included in this study
3. Absence of distant metastases as demonstrated by history and physical examination, FBC, screening profile including liver function tests, PSA and bone scan
4. All patients must have an MRI/CT of the prostate and pelvis to investigate the nodal status and precise T-stage. This MRI/CT scan must be performed prior to commencement of hormonal therapy. Suspicious nodes need to be histologically proven to be benign before the patient can be included in the study). M0 on staging.
5. No previous surgery for urinary conditions except TURP or TRUS
6. KPS \> or equal to 60
7. Age \>18 years
8. Provision of written informed consent in line with ICH-GCP guidelines
Exclusion Criteria:
1. Previous RT to the pelvic region
2. The patient has nodal involvement or it is decided to electively treat pelvic lymph nodes
3. The patient has had a bilateral orchidectomy
4. The patient has previously received a full course of hormonal treatment for his prostate cancer
5. The patient has or has had other malignancies within the last 5 years (non-melanoma skin cancer is permitted)
6. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial or if it is felt by the research/ medical team that the patient may not be able to comply with the protocol
7. Patients who have had a prostatectomy
8. The presence of hip prostheses
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00951535
Study Brief:
Protocol Section:
NCT00951535