COMPLETED

Prostate Cancer Upgrading Reference Set

Conditions

Prostate Cancer Radical Prostatectomy Prostate biopsy Upgrading Upgrading Reference set

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Biomarkers and Clinical Parameters Associated With Gleason Score Upgrading

Quick Facts

Study Start:2014-08

Study Completion:2025-06-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT02189486

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 99 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	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.

Inclusion Criteria

Exclusion 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).

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

Principal Investigator

Ian M Thompson Jr, MD

PRINCIPAL_INVESTIGATOR

University of Texas

Study Locations (Sites)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

Ian M Thompson Jr, MD, PRINCIPAL_INVESTIGATOR, University of Texas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-08

Study Completion Date2025-06-16

Study Record Updates

Study Start Date2014-08

Study Completion Date2025-06-16

Terms related to this study

Keywords Provided by Researchers

Prostate Cancer
Radical Prostatectomy
Prostate biopsy
Upgrading
Upgrading Reference set

Additional Relevant MeSH Terms

Prostate Cancer