Prostate CancerPhase 1NCT00977457
Genetic Testing in Predicting Biomarkers of Recurrence in Patients With Prostate Cancer Undergoing Surgery
A Phase 1 study testing DNA analysis, DNA methylation analysis and RNA analysis in people with Prostate Cancer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This trial studies the side effects and best way to perform genetic testing in predicting biomarkers of recurrence in patients with prostate cancer undergoing surgery. Collecting and storing samples of tissue, blood, and other body fluids from patients to test in the laboratory and collecting information about the… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- DNA analysis, DNA methylation analysis and RNA analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,045 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2007to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All men undergoing robotic prostatectomy or cystoprostatectomy at City of Hope will be eligible for the study
Who cannot join
- Men who undergo neoadjuvant treatment with Androgen Deprivation Therapy (ADT) or salvage prostatectomy including those who have had brachytherapy will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010-3000
About this study
Official title: Pre-Surgical EPS Biomarkers as Predictors of Biochemical Recurrence
This trial studies the side effects and best way to perform genetic testing in predicting biomarkers of recurrence in patients with prostate cancer undergoing surgery. Collecting and storing samples of tissue, blood, and other body fluids from patients to test in the laboratory and collecting information about the patient's health and treatment may help doctors learn more about cancer and help predict the recurrence of prostate cancer
Read the detailed description
PRIMARY OBJECTIVES: I. To explore the performance of these models in predicting the likelihood of biochemical recurrence (BCR).
SECONDARY OBJECTIVES: I. To explore the performance of these models in predicting upgrading and upstaging prior to surgery. II. To explore the performance of these models in improving risk stratification among patients eligible for active surveillance. III. To determine whether prostatic massage or surgery raises the count of circulating tumor cells (CTC) in post-digital rectal exam (DRE) blood specimens.
OUTLINE: Patients receive prostatic massage and undergo a digital rectal exam (DRE). Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.
- Conditions
- Prostate Cancer
- Being tested
- DNA analysis, DNA methylation analysis, RNA analysis, gene expression analysis, polymerase chain reaction
- Keywords
- stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
DNA methylation analysisGenetic
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
RNA analysisGenetic
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
gene expression analysisGenetic
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
polymerase chain reactionGenetic
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
diagnostic laboratory biomarker analysisOther
Performed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery
therapeutic conventional surgeryProcedure or surgery
Also called Undergo robotic prostatectomy or cystoprostatectomy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (specimen collection) | Experimental | Patients receive prostatic massage and undergo a digital rectal examination. Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery. Receives: Genetic: DNA analysis; Genetic: DNA methylation analysis; Genetic: RNA analysis; Genetic: gene expression analysis; Genetic: polymerase chain reaction; Other: diagnostic laboratory biomarker analysis; Procedure: therapeutic conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of these models in predicting the likelihood of BCR
Logistic regression and artificial neural networks will be used.
Measured: Visit 2 (intraoperative setting)
Secondary outcomes (3)
Comparison of the performance in these models in predicting upgrading and upstaging prior to surgery
Logistic regression and artificial neural networks will be used.
Measured: Visit 2 (intraoperative setting)
Comparison of the performance of these models in improving risk stratification among patients eligible for active surveillance
Logistic regression and artificial neural networks will be used.
Measured: Visit 2 (intraoperative setting)
Determination whether prostatic massage or surgery raises the count of circulating tumor cells (CTCs) in post-DRE blood specimens
Logistic regression and artificial neural networks will be used.
Measured: Visit 2 (intraoperative setting)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study start26 Nov 2007
- Primary completion13 Jul 2016
- Study completion30 Jun 2027 (estimated)
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 City of Hope Medical CenterThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,045 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Steven S. Smith, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977457
- Sponsor's protocol ID
- 06072
- Other IDs
- P30CA033572, CHNMC-06072, CDR0000644208, 5R01CA102521, NCI-2011-00980
- Status last verified
- Aug 2026
- First submitted
- 12 Sep 2009
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Surgical EPS Biomarkers as Predictors of Biochemical Recurrence
- ClinicalTrials.gov ID
- NCT00977457
- Acronym / sponsor ID
- 06072
- Conditions
- Prostate Cancer
- Keywords
- stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,045 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Nov 2007 (actual)
- Primary completion
- 13 Jul 2016 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 15 Sep 2009 (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.
This trial studies the side effects and best way to perform genetic testing in predicting biomarkers of recurrence in patients with prostate cancer undergoing surgery. Collecting and storing samples of tissue, blood, and other body fluids from patients to test in the laboratory and collecting information about the patient's health and treatment may help doctors learn more about cancer and help predict the recurrence of prostate cancer
Detailed description
PRIMARY OBJECTIVES: I. To explore the performance of these models in predicting the likelihood of biochemical recurrence (BCR).
SECONDARY OBJECTIVES: I. To explore the performance of these models in predicting upgrading and upstaging prior to surgery. II. To explore the performance of these models in improving risk stratification among patients eligible for active surveillance. III. To determine whether prostatic massage or surgery raises the count of circulating tumor cells (CTC) in post-digital rectal exam (DRE) blood specimens.
OUTLINE: Patients receive prostatic massage and undergo a digital rectal exam (DRE). Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (specimen collection) | Experimental | Genetic: DNA analysis, Genetic: DNA methylation analysis, Genetic: RNA analysis, Genetic: gene expression analysis, Genetic: polymerase chain reaction, Other: diagnostic laboratory biomarker analysis, Procedure: therapeutic conventional surgeryPatients receive prostatic massage and undergo a digital rectal examination. Laboratory assessments are performed and blood samples are collected for molecular biology testing. On the day of the scheduled prostatectomy, a second blood collection is performed prior to surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All men undergoing robotic prostatectomy or cystoprostatectomy at City of Hope will be eligible for the study
Key exclusion criteria (1 listed)
- Men who undergo neoadjuvant treatment with Androgen Deprivation Therapy (ADT) or salvage prostatectomy including those who have had brachytherapy will be excluded
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 |
|---|---|---|
| DNA analysisPerformed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery | Genetic | Diagnostic (specimen collection) |
| DNA methylation analysisPerformed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery | Genetic | Diagnostic (specimen collection) |
| RNA analysisPerformed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery | Genetic | Diagnostic (specimen collection) |
| gene expression analysisPerformed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery | Genetic | Diagnostic (specimen collection) |
| polymerase chain reactionPerformed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery | Genetic | Diagnostic (specimen collection) |
| diagnostic laboratory biomarker analysisPerformed on Post-massage urine (PMU) and/or expressed prostatic secretions (EPS) samples obtained at the time of surgery | Other | Diagnostic (specimen collection) |
| therapeutic conventional surgeryAlso: Undergo robotic prostatectomy or cystoprostatectomy | Procedure or surgery | Diagnostic (specimen collection) |
Primary outcome
Performance of these models in predicting the likelihood of BCR
Time frame: Visit 2 (intraoperative setting)
Logistic regression and artificial neural networks will be used.
3 secondary outcomes
Comparison of the performance in these models in predicting upgrading and upstaging prior to surgery
Time frame: Visit 2 (intraoperative setting)
Comparison of the performance of these models in improving risk stratification among patients eligible for active surveillance
Time frame: Visit 2 (intraoperative setting)
Determination whether prostatic massage or surgery raises the count of circulating tumor cells (CTCs) in post-DRE blood specimens
Time frame: Visit 2 (intraoperative setting)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 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.
Steven S. Smith, PhD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DNA analysis, DNA methylation analysis and RNA analysis in people with Prostate Cancer, run by City of Hope Medical Center 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 1 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Performance of these models in predicting the likelihood of BCR (time frame: Visit 2 (intraoperative setting)). 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 20 Aug 2026.