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Prostate Cancer Upgrading Reference Set

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ClinicalTrials.gov Identifier: NCT02189486
Recruitment Status : Recruiting
First Posted : July 14, 2014
Last Update Posted : June 30, 2021
Sponsor:
Collaborators:
Emory University
Stanford University
University of California, Irvine
University of Michigan
The Cleveland Clinic
University of Washington
Fred Hutchinson Cancer Research 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)
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Prostate Cancer

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).

Study Design
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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 : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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
Blood, voided urine and prostate tissue slides and blocks

Eligibility Criteria
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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
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.
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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
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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         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Emory University
Stanford University
University of California, Irvine
University of Michigan
The Cleveland Clinic
University of Washington
Fred Hutchinson Cancer Research 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)
Investigators
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Principal Investigator: Ian M Thompson Jr, MD University of Texas
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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: June 30, 2021
Last Verified: June 2021
Keywords provided by The University of Texas Health Science Center at San Antonio:
Prostate Cancer
Radical Prostatectomy
Prostate biopsy
Upgrading
Upgrading Reference set
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases