Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Mayo Clinic
PRIMARY OBJECTIVE:
I. To assess the accuracy of MDM candidates (individually and in combination) assayed from urine and prostatic fluid (collected following digital prostate massage) for detection of CAP.
OUTLINE: This is an observational study.
PHASE I: Participants undergo urine sample collection on study.
PHASE II: Participants undergo standard prostate massage and collection of prostatic fluid and urine samples on study.
All participants complete a questionnaire and have their medical records reviewed on study.
Age
18–any
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
\* Patient is 18 years or older
* Patient has a histologically confirmed diagnosis of prostatic carcinoma/adenocarcinoma with a corresponding Gleason score OR is scheduled for a prostate biopsy for an elevated Prostate Specific Antigen (PSA), palpable prostate nodule, an abnormal imaging finding, or worrisome PSA velocity
You may not be if
\* Patient has had a transplant prior to sample collection
* Patient has had Androgen (e.g. Flutamide, Androcur, Casodex, Nilandron) or Luteinizing hormone-releasing hormone (LHRH) (e.g. Lupron, Zoladex) therapy
* Patient has transurethral instrumentation (cystoscopy, placement of urinary catheter) within the 7 days prior to sample collection
* Patient has chronic indwelling urinary catheter
* Patient has had a urinary tract infection within the 14 days prior to sample collection
* Patient has immunotherapy (e.g. Kwon study drugs) for prostate cancer prior to sample collection
* Patient has a history of bladder cancer
* Patient has had a biopsy within the last 6 weeks (excluding non-melanoma skin biopsies) of sample collection
* Patient has had surgery to completely remove current target pathology prior to sample collection
* Patient has a prior history of prostate carcinoma/adenocarcinoma
* Patient has received chemotherapy class drugs (e.g. Docetaxel, Methotrexate) within the 5 years prior to sample collection
* Patient has received therapeutic radiation prior to sample collection
* Patient has had focal ablation \[e.g. High-intensity focused ultrasound (HIFU) or cryoablation\] of prostate cancer prior to sample collection
* Patient has known primary cancer outside of the prostate within the last 5 years (not including basal cell or squamous cell skin cancers) of sample collection
