Prostate Cancer Upgrading Reference Set
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 35 - 99 |
| Updated: | 3/31/2019 |
| Start Date: | August 2014 |
| End Date: | December 31, 2020 |
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.
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.
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).
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).
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.
We found this trial at
1
site
4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Ian M Thompson Jr., MD
Phone: 210-567-0178
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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