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 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT00937768
Eligibility Criteria:
Inclusion Criteria:
* PRE-REGISTRATION:
* Informed consent explained and signed prior to any study related procedures
* Patients with any one of the following "high risk" criteria:
* Clinical or pathological Gleason score 8-10
* Prostate-specific antigen (PSA) \> 20 ng/ml at initial presentation prior to radical prostatectomy
* Willingness to provide mandatory tissue for research purposes
* Willingness to provide mandatory blood for research purposes
* Has no history of androgen deprivation therapy within the past 6 months or has been treated neoadjuvantly up to 6 months prior to radical prostatectomy with the following agents; luteinizing hormone-releasing hormone (LHRH) agonists, anti-androgens, 5 alpha-reductase inhibitors, and peripheral anti-androgens
* REGISTRATION:
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2; or Karnofsky performance of \> 60%
* Patients with any one of the following "high risk" criteria:
* Gleason, prostate specific antigen, seminal vesicle and margin status (GPSM) score \>= 10 \[GS + 1\*(PSA 4-10)+2\*(PSA 10.1-20)+3\*(PSA \> 20)+2\*(seminal vesicular or nodal involvement) +2\*(margin)\](determined post radical prostatectomy)
* Post prostatectomy seminal vesicle invasion (pT3b) or pT4
* Two or less microscopic lymph nodal metastasis determined at the time of prostatectomy OR
* Gleason 4+3 at the time of prostatectomy with margin positivity
* Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) =\< 2 x institutional upper limit of normal (ULN)
* Total bilirubin =\< 2 x institutional ULN
* For patients identified as high-risk on the basis of pathological criteria after undergoing radical prostatectomy: interval time for study enrollment after radical prostatectomy will be =\< 28 days of the prostatectomy
* For patients identified as high-risk prior to undergoing radical prostatectomy: patients presenting with a high Gleason score (8-10) and/or a PSA \> 20 ng/ml are deemed eligible for study participation and study registration as long as the eligibility criteria is reconfirmed post radical prostatectomy; these patient groups may choose to register prior to or after prostatectomy
* Study randomization must occur =\< 28 days of radical prostatectomy; all patients consented on the trial, whether consented in the pre-prostatectomy or post-prostatectomy period, will be randomized to study treatments =\< 28 days of prostatectomy
* Ability to complete questionnaire(s) by themselves or with assistance
Exclusion Criteria:
* PRE-REGISTRATION
* Transitional cell, small cell, or squamous cell carcinoma of the prostate; NOTE: patients consented for participation prior to prostatectomy, if detected to have above listed histo-pathologies after prostatectomy will be deemed ineligible and not proceed to study randomization
* History of primary prostate cancer treatment
* Evidence of clinical nodal disease (N1) or grossly evident metastasis at the time of enrollment
* History of bilateral orchiectomy; unilateral orchiectomy with normal range serum testosterone levels will be allowed for enrollment
* Evidence of metastasis on radiographic metastatic workup within a preceding period of 4 months from the time of study entry, including whole body radionuclide bone scan, computed tomography (CT) and/or magnetic resonance (MR) scan of the pelvis and abdomen; otherwise will perform at the time of the baseline tests and result must be normal to continue on study; results of ProstaScint or other radionuclide scans, excluding radionuclide bone scans, will NOT be used to establish metastatic disease if all other studies are negative
* Receiving other experimental drugs =\< 4 weeks prior to consenting
* Uncontrolled infection
* History of other cancer, excluding squamous cell and basal cell skin cancers, within the preceding 2 years
* Documented history of human immunodeficiency virus (HIV) positivity or other acquired immunodeficiency disorder, congenital immunodeficiency disorder, or history of organ transplantation
* Unable to follow up every three months for the first year to Mayo Clinic, Rochester for receiving LHRH analogues or study monitoring
* REGISTRATION:
* Uncontrolled infection
* Unable to follow up every three months for the first year to Mayo Clinic, Rochester for receiving LHRH analogues or study monitoring
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00937768
Study Brief:
Protocol Section:
NCT00937768