Prostate CancerNCT02189486
Prostate Cancer Upgrading Reference Set
An observational study of Prostate Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 382 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 16 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Biomarkers and Clinical Parameters Associated With Gleason Score Upgrading
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.
Read the 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.
- 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.
- Patient must have selected radical prostatectomy as treatment for prostate cancer.
- Signed informed consent. 7. 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 Early Detection Research Network (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).
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Radical Prostatectomy, Prostate biopsy, Upgrading, Upgrading Reference set
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years
Secondary outcomes (1)
Presence of prostate cancer beyond the prostate at radical prostatectomy (pathologic T3 disease)
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startAug 2014
- Primary completion16 Jun 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 382 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, Stanford University, University of California, Irvine, University of Michigan, The Cleveland Clinic, University of Washington, Fred Hutchinson Cancer Center, University of Miami, Johns Hopkins University, M.D. Anderson Cancer Center, Weill Medical College of Cornell University, Icahn School of Medicine at Mount Sinai, Eastern Virginia Medical School, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ian M Thompson Jr, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189486
- Sponsor's protocol ID
- HSC20140367H
- Other IDs
- 5P30CA054174
- Status last verified
- Jan 2026
- First submitted
- 8 Jul 2014
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers and Clinical Parameters Associated With Gleason Score Upgrading
- ClinicalTrials.gov ID
- NCT02189486
- Acronym / sponsor ID
- HSC20140367H
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Radical Prostatectomy, Prostate biopsy, Upgrading, Upgrading Reference set
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 382 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Emory University, Stanford University, University of California, Irvine, University of Michigan, The Cleveland Clinic, University of Washington, Fred Hutchinson Cancer Center, University of Miami, Johns Hopkins University, M.D. Anderson Cancer Center, Weill Medical College of Cornell University, Icahn School of Medicine at Mount Sinai, Eastern Virginia Medical School, National Cancer Institute (NCI)
- Study start
- Aug 2014
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Patient must have selected radical prostatectomy as treatment for prostate cancer.
- Signed informed consent. 7. 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 Early Detection Research Network (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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 35 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Presence of prostate cancer beyond the prostate at radical prostatectomy (pathologic T3 disease)
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian M Thompson Jr, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate cancer tumor upgrading at time of radical prostatectomy (Gleason 3+4 or higher grade) (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.