Prostate Cancer Upgrading Reference Set
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ClinicalTrials.gov Identifier: NCT02189486 |
Recruitment Status :
Recruiting
First Posted : July 14, 2014
Last Update Posted : April 1, 2020
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Condition or disease |
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Prostate Cancer |
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).
Study Type : | Observational |
Estimated Enrollment : | 600 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Biomarkers and Clinical Parameters Associated With Gleason Score Upgrading |
Study Start Date : | August 2014 |
Estimated Primary Completion Date : | March 2021 |
Estimated Study Completion Date : | December 31, 2021 |

Group/Cohort |
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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.
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- Prostate cancer tumor upgrading at time of radical prostatectomy (Gleason 3+4 or higher grade) [ Time Frame: 4 years ]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
- Presence of prostate cancer beyond the prostate at radical prostatectomy (pathologic T3 disease) [ Time Frame: 10 years ]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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 35 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189486
United States, Texas | |
University of Texas Health Science Center at San Antonio | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Robert Hudson, BS 210-450-8688 hudsonr1@uthscsa.edu | |
Principal Investigator: Ian M Thompson Jr., MD |
Principal Investigator: | Ian M Thompson Jr, MD | University of Texas |
Responsible Party: | The University of Texas Health Science Center at San Antonio |
ClinicalTrials.gov Identifier: | NCT02189486 |
Other Study ID Numbers: |
HSC20140367H 5P30CA054174 ( U.S. NIH Grant/Contract ) |
First Posted: | July 14, 2014 Key Record Dates |
Last Update Posted: | April 1, 2020 |
Last Verified: | March 2020 |
Prostate Cancer Radical Prostatectomy Prostate biopsy Upgrading Upgrading Reference set |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |