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 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT00706966
Eligibility Criteria:
Inclusion criteria:
* Histologically confirmed adenocarcinoma of the prostate
* Clinical stage T1b, T1c, or T2a disease
* Gleason score ≤ 6
* Maximal prostate-specific antigen (PSA) \< 10 ng/mL
* Demonstrates intra-prostatic metabolite abnormalities, consistent with adenocarcinoma of the prostate (i.e., ≥ 3 voxels with magnetic resonance spectroscopy imaging \[MRSI\] scores 4-5) by baseline MRI and MRSI
* Has symptomatic benign prostatic hypertrophy and is currently undergoing watchful waiting OR opting to undergo permanent seed implant (i.e., brachytherapy), but requires neoadjuvant androgen suppression for prostate shrinkage
* No regional lymph node involvement
* No evidence of distant metastases
* Zubrod performance status 0-1
* Able to swallow and retain oral medications
Exclusion Criteria:
* Other prior or concurrent invasive cancer, other than localized basal cell or squamous cell carcinoma of the skin
* Contraindications to MRI/MRSI, including any of the following:
* Prostate biopsy (within the past 8 weeks) and any continued post-biopsy bleeding
* Rectal bleeding
* Anal fissures
* Rectal surgery (end-to-end anastomosis)
* Inflammatory bowel disease
* Prior radical prostatectomy
* Hip replacement
* Certain types of penile implants
* Vascular clips
* Known anaphylactic reaction to latex compounds
* Anticoagulant drugs
* Severe claustrophobia
* Cardiac pacemaker
* Metal in eye
* Any other metallic or foreign object in the body
* Unstable serious co-morbidities including, but not limited to, myocardial infarction, coronary artery syndrome, cardiac arrhythmias, symptomatic congestive heart failure, or cerebrovascular accident
* Major medical or psychiatric illness that, in the investigator's opinion, would preclude the completion of treatment and interfere with follow up
* Known hypersensitivity to any 5α-reductase inhibitor or drug chemically related to the study drug
* Prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
* Prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
* Prior or concurrent cytotoxic chemotherapy for prostate cancer
* Prior hormonal therapy, such as luteinizing hormone-releasing hormone agonists (e.g., goserelin or leuprolide acetate), antiandrogens (e.g., flutamide or bicalutamide), or estrogens (e.g., diethylstilbestrol)
* Prior or concurrent finasteride, dutasteride, other drugs with known antiandrogenic properties (e.g., spironolactone or progestational agents), or any dietary or herbal supplement (e.g., selenium, vitamin E, saw palmetto, or PC-SPES)
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT00706966
Study Brief:
Protocol Section:
NCT00706966