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 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT00439751
Eligibility Criteria:
Inclusion Criteria:
1. Males over 18 years of age with histological confirmation of adenocarcinoma of the prostate.
2. Biochemical progression after radical radiotherapy with a total prostate dose \> 52 Gy.
* In patients without previous radical prostatectomy, biochemical progression is defined as PSA in the range of nadir + 2 ng/mL (Phoenix definition) to ≤ 6 ng/mL (this PSA must be within 30 days of randomization).
* In patients with previous radical prostatectomy, biochemical progression is defined as a rising PSA (at least 2 values) in the range of 0.4 ng/mL to ≤ 3 ng/mL (most recent PSA must be within 30 days of randomization).
Exclusion Criteria:
1. Patients who are within 4 years of their brachytherapy implantation date.
2. Patients with medical conditions in which goserelin or bicalutamide is contraindicated in the opinion of the supervising oncologist or urologist.
3. Patients with another active malignancy or malignancy treatment within 5 years (basal or squamous cell skin cancers are not excluded from this trial).
4. Patients with geographic inaccessibility precluding them from necessary follow-up.
5. Failure to provide written informed consent.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00439751
Study Brief:
Protocol Section:
NCT00439751