Prostate Cancer Upgrading Reference Set

NCT02189486 | Completed DMC

• 2 other identifiers: HSC20140367H5P30CA054174
• Study Type: observational
• Target: 382
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Radical Prostatectomy; Prostate biopsy; Upgrading; Upgrading Reference set

Outcome Measures

Primary Outcomes (1)

• Prostate cancer tumor upgrading at time of radical prostatectomy (Gleason 3+4 or higher grade)

  The primary endpoint of this study is the presence of tumor upgrading at the time of radical prostatectomy. Upgrading is defined as: Gleason 3+4 or higher grade

  4 years

Secondary Outcomes (1)

• Presence of prostate cancer beyond the prostate at radical prostatectomy (pathologic T3 disease)

  10 years

Study Arms (1)

Prostate Cancer Cohort

Men with prostate cancer who have elected radical prostatectomy for their treatment of their prostate cancer within two years after prostate biopsy.

Eligibility Criteria

• Age: 35 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit a cohort of 600 men with prostate cancer who have elected radical prostatectomy for treatment of their prostate cancer within two years after prostate biopsy. This biopsy must show no greater grade than Gleason 3+3 disease as determined on central pathology review. The patient may have had previous biopsies that showed cancer but may never have had a tumor grade greater than Gleason 3+3.

You may qualify if:

• Prostate cancer, confirmed on prostate biopsy, within two years of scheduled radical prostatectomy.
• 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.)
• 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.)
• Slides must be available for Central Pathology Laboratory review on any biopsy showing prostate cancer. FFPE Blocks may also be requested if available.
• Patient must have selected radical prostatectomy as treatment for prostate cancer.
• Signed informed consent.
• Blocks and/or slides from prostate biopsy and from radical prostatectomy must be available for analysis by Central Pathology laboratory.
• Willingness to provide long-term follow-up information regarding additional treatments and cancer status.
• Willingness to provide blood and urine specimens prior to radical prostatectomy for placement in the EDRN Upgrading Reference Set repository.
• Willingness to provide demographic and clinical information related to prostate cancer and prostate cancer risk (e.g., race/ethnicity, family history of prostate cancer).

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: collaborator
• University of California, Irvine: collaborator
• University of Michigan: collaborator
• The Cleveland Clinic: collaborator
• University of Washington: collaborator
• Fred Hutchinson Cancer Center: collaborator
• University of Miami: collaborator
• Johns Hopkins University: collaborator
• M.D. Anderson Cancer Center: collaborator
• Weill Medical College of Cornell University: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator
• Eastern Virginia Medical School: collaborator
• National Cancer Institute (NCI): collaborator
• The University of Texas Health Science Center at San Antonio: lead
• Emory University: collaborator

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, voided urine and prostate tissue slides and blocks

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ian M Thompson Jr, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 14, 2014
• Study Start: August 1, 2014
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

US (1)