Prostate Cancer Upgrading Reference Set

NCT ID: NCT02189486

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 382 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2025-06-16

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.

Detailed Description

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 A secondary study endpoint is presence of prostate cancer beyond the prostate (pathologic T3 disease) at radical prostatectomy. (This finding may be considered as a rationale for treatment.) Evidence of pathologic stage T3 or higher disease will be assessed by the presence of: (1) seminal vesicle invasion or (2) positive surgical margins or (3) established extracapsular extension or (4) lymph node involvement by tumor. It should be noted that pathologic stage T3 disease, while generally portending a greater risk of disease recurrence, may not be an intrinsic feature of disease prognosis but can be an artifact of surgical technique. Nonetheless, a secondary risk assessment tool will include both a Gleason 7-10 endpoint plus any patients with pT3+ disease to a composite endpoint that could indicate disease best managed with treatment in lieu of active surveillance.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 (formalin fixed paraffin embedded) 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 Early Detection Research Network (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).

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

Eastern Virginia Medical School

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian M Thompson Jr, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Countries

United States

Other Identifiers

5P30CA054174

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC20140367H

Identifier Type: -

Identifier Source: org_study_id