Print

Lay Description

Research repository designed to establish prostate cancer upgrading reference set and development of a risk prediction tool. Repository will include clinical information and biologics on a cohort of 240 men, to predict presence of high grade cancer at time of prostatectomy (removal of prostate) among patients with a low grade cancer diagnosis at time of biopsy.

Category

IRB Number
20140367HU
NCT Number
NCT02189486
Open to Enrollment
Yes

Eligibility

Eligible Ages
Between 35 Years and 99 Years
Eligible Genders
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Prostate cancer, confirmed on prostate biopsy, within two years of scheduled radical prostatectomy.
  2. Prostate cancer must be graded as Gleason 3+3 on the biopsy immediately prior to radical prostatectomy. (Secondary eligibility will be established on central review of pathology slides, and blocks if available, at Cornell Central Pathology Laboratory to confirm eligibility.)
  3. Prostate cancer may have been detected on prior biopsy as well but must not be greater than Gleason 3+3. (Also requires Central Pathology Laboratory review.)
  4. Slides must be available for Central Pathology Laboratory review on any biopsy showing prostate cancer. FFPE Blocks may also be requested if available.
  5. Patient must have selected radical prostatectomy as treatment for prostate cancer.
  6. Signed informed consent.
  7. Blocks and/or slides from prostate biopsy and from radical prostatectomy must be available for analysis by Central Pathology laboratory.
  8. Willingness to provide long-term follow-up information regarding additional treatments and cancer status.
  9. Willingness to provide blood and urine specimens prior to radical prostatectomy for placement in the EDRN Upgrading Reference Set repository.
  10. Willingness to provide demographic and clinical information related to prostate cancer and prostate cancer risk (e.g., race/ethnicity, family history of prostate cancer).

Exclusion Criteria

  1. Gleason score greater than 3+3 on any prior prostate biopsy.
  2. Any treatment other than radical prostatectomy planned for prostate cancer.
  3. Prior treatment of the prostate with androgen deprivation, radiation, or other cytotoxic chemotherapy.

Study Design

Arm Groups

Study Contact

Austen Clark
(210) 450-8688
clarka5@uthscsa.edu

Robin Leach
(210) 567-6947
leach@uthscsa.edu

Ian Thompson
(210) 567-5643
thompsoni@uthscsa.edu

Brandi Weaver
(210) 567-0158
weaverb@uthscsa.edu

Principal Investigator
Ian Thompson