Prostate CancerNCT01594502
Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
An observational study of Prostate Cancer, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The goal of this study is to apply cutting-edge imaging approaches, incorporating machine-learning for pattern recognition and multispectral analysis, to the development and validation of intermediate endpoint biomarkers in benign tissue that characterize the response to 5α-reductase inhibitor chemoprevention as well… Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Dutasteride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jul 2016
- 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 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Probability Sample
Who may be able to join
- completed REDUCE trial (Year 4 exit biopsy with blocks and HE slides available; i.e., U.S. participants only)
- compliant with assigned treatment based on either: (dutasteride group) at least 3 post-baseline serum DHT levels ≥ 50% lower than baseline, or (placebo group) at least 3 post-baseline serum DHT levels with none showing ≥ 50% decrease from baseline
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: R01 CA155301: Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
The goal of this study is to apply cutting-edge imaging approaches, incorporating machine-learning for pattern recognition and multispectral analysis, to the development and validation of intermediate endpoint biomarkers in benign tissue that characterize the response to 5α-reductase inhibitor chemoprevention as well as the risk of prostate cancer among men with negative biopsies.
- Conditions
- Prostate Cancer
- Being tested
- Dutasteride, Placebo
- Keywords
- prostate cancer, dutasteride
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DutasterideDrug
0.5 mg daily
PlaceboDrug
Placebo Comparator
| Study group | Role | What they receive |
|---|---|---|
| Dutasteride Year 2 PCa | Subject assigned to dutasteride, prostate cancer found on Year 2 biopsy. Receives: Drug: Dutasteride | |
| Placebo Year 2 no PCa, Year 4 PCa | Subject assigned to placebo, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy. Receives: Drug: Placebo | |
| Dutasteride Year 2 no PCa, Year 4 PCa | Subject assigned to dutasteride, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy. Receives: Drug: Dutasteride | |
| Placebo, Year 2 and 4 no PCa | Subject assigned to placebo, no prostate cancer found on Year 2 or Year 4 biopsy. Receives: Drug: Placebo | |
| Dutasteride, Year 2 and 4 no PCa | Subject assigned to dutasteride, no prostate cancer found on Year 2 or Year 4 biopsy. Receives: Drug: Dutasteride | |
| Placebo, Year 2 PCa | Subject assigned to placebo, prostate cancer found on Year 2 biopsy. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of dutasteride (vs. placebo) using multi-feature scores derived from digital image analysis on both nuclear and architectural features in benign prostate tissue.
Measured: Year 4
Secondary outcomes (2)
Multivariable treatment-response score between subjects who develop PCa while on dutasteride and those who do not.
Measured: Year 4
Magnitude of association between nuclear phenotype in benign biopsies, and subsequent risk of PCa in untreated men at elevated risk.
Measured: Year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2012 (estimated)
- Study startSep 2011
- Primary completionNov 2015
- Study completionJul 2016
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.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Peter Gann, University of Illinois Chicago
- Investigators
- Peter H Gann, MD, ScD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594502
- Sponsor's protocol ID
- 2010-0670
- Other IDs
- R01CA155301
- Status last verified
- Oct 2020
- First submitted
- 17 Apr 2012
- Last updated
- 12 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- R01 CA155301: Validation of Digital Morphometry for Cancer Risk in Benign Prostate Biopsies
- ClinicalTrials.gov ID
- NCT01594502
- Acronym / sponsor ID
- 2010-0670
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, dutasteride
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 May 2012 (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.
The goal of this study is to apply cutting-edge imaging approaches, incorporating machine-learning for pattern recognition and multispectral analysis, to the development and validation of intermediate endpoint biomarkers in benign tissue that characterize the response to 5α-reductase inhibitor chemoprevention as well as the risk of prostate cancer among men with negative biopsies.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dutasteride Year 2 PCa | – | Drug: DutasterideSubject assigned to dutasteride, prostate cancer found on Year 2 biopsy. |
| Placebo Year 2 no PCa, Year 4 PCa | – | Drug: PlaceboSubject assigned to placebo, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy. |
| Dutasteride Year 2 no PCa, Year 4 PCa | – | Drug: DutasterideSubject assigned to dutasteride, no prostate cancer found on Year 2 biopsy, but prostate cancer found on Year 4 biopsy. |
| Placebo, Year 2 and 4 no PCa | – | Drug: PlaceboSubject assigned to placebo, no prostate cancer found on Year 2 or Year 4 biopsy. |
| Dutasteride, Year 2 and 4 no PCa | – | Drug: DutasterideSubject assigned to dutasteride, no prostate cancer found on Year 2 or Year 4 biopsy. |
| Placebo, Year 2 PCa | – | Drug: PlaceboSubject assigned to placebo, prostate cancer found on Year 2 biopsy. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Probability Sample
Key inclusion criteria (2 listed)
- completed REDUCE trial (Year 4 exit biopsy with blocks and HE slides available; i.e., U.S. participants only)
- compliant with assigned treatment based on either: (dutasteride group) at least 3 post-baseline serum DHT levels ≥ 50% lower than baseline, or (placebo group) at least 3 post-baseline serum DHT levels with none showing ≥ 50% decrease from baseline
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dutasteride0.5 mg daily | Drug | Dutasteride Year 2 PCa, Dutasteride Year 2 no PCa, Year 4 PCa, Dutasteride, Year 2 and 4 no PCa |
| PlaceboPlacebo Comparator | Drug | Placebo Year 2 no PCa, Year 4 PCa, Placebo, Year 2 PCa, Placebo, Year 2 and 4 no PCa |
Primary outcome
Effects of dutasteride (vs. placebo) using multi-feature scores derived from digital image analysis on both nuclear and architectural features in benign prostate tissue.
Time frame: Year 4
2 secondary outcomes
Multivariable treatment-response score between subjects who develop PCa while on dutasteride and those who do not.
Time frame: Year 4
Magnitude of association between nuclear phenotype in benign biopsies, and subsequent risk of PCa in untreated men at elevated risk.
Time frame: Year 4
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 12 Oct 2020.
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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.
Peter H Gann, MD, ScD principal investigator
University of Illinois Chicago
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 University of Illinois Chicago 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 2 inclusion and 1 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 12 Oct 2020. 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?
Effects of dutasteride (vs. placebo) using multi-feature scores derived from digital image analysis on both nuclear and architectural features in benign prostate tissue. (time frame: Year 4). 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 12 Oct 2020.