Prostate CancerNCT01376661
Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study
An observational study of Prostate Cancer, run by St. Joseph Hospital of Orange at 1 site in United States.
Trial summary
The purpose of this research study is to monitor the feasibility and outcome of the Active Surveillance Program for men with low risk prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to 1 Sep 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 18 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with low risk prostate cancer.
Who may be able to join
- At least 18 years of age
- Histological documented adenocarcinoma of the prostate either newly diagnosed or previously diagnosed. Subjects who are diagnosed more than 3 months prior to time of enrollment in the active surveillance program must have biopsy repeated.
- PSA < 10 ng/ml within 1 month of program enrollment
- Clinical stage less than or equal to T2a
- Biopsy sampling with at least 10-12 cores
- Gleason score less than or equal to 3 + 3
Show all 12Show fewer
- No more than 2 cores involved
- No core more than 50% involved
- Eligible for definitive therapy
- Able to provide informed consent
- Able to complete a QOL questionnaire
- Able to comply with the scheduled follow-up appointments
Who cannot join
- See inclusion criteria for eligibility
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph Hospital of Orange
Orange, California, 92868
About this study
The purpose of this research study is to monitor the feasibility and outcome of the Active Surveillance Program for men with low risk prostate cancer.
Read the detailed description
The purpose of this observational study is to prospectively monitor the outcome associated with men who meet the eligibility criteria for low risk prostate cancer and elected to participate in the active surveillance program at The Center for Cancer Prevention and Treatment at St. Joseph Hospital. We hope to demonstrate that men who are compliant with a closely monitored active surveillance program for low risk prostate cancer will achieve favorable outcomes by: 1) avoiding the side effects of definitive therapy that may not be necessary; 2) retaining quality of life (QOL) and normal activities; 3) avoiding unnecessary treatment; and 4) decreased health care costs. In addition, we will monitor the possible adverse outcomes that may be associated with the active surveillance program including suboptimal response and/or greater side effects due to delayed initiation of therapy; psychological impact on the patients and caregivers due to anxiety of living with an untreated cancer and/or the requirement for frequent medical examination and periodic prostate biopsies.
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Active Surveillance, Low risk 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.
| Study group | Role | What they receive |
|---|---|---|
| Active Surveillance/ Prostate Cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of enrolled subjects who remain compliant free until disease progression.
This measurement will monitor the feasibility of the Active Surveillance Program for men with low risk prostate cancer
Measured: 10 years
Secondary outcomes (4)
Percentage of enrolled subjects who require definitive therapy
Measured: 10 years
Quality of Life as measured by patient survey.
Measured: 10 Years
Overall survival
This will be a measurement of the treatment outcome.
Measured: 10 years
Cost/Benefit Analysis
This measure will determine the feasibility of the Active Surveillance Program.
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startMay 2009
- Primary completion1 Sep 2016
- Study completion1 Sep 2016
Why it stopped: Early termination due to PI's decision to discontinue research activities.
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.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph Hospital of Orange
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Greenberger, MD, Principal investigator, St. Joseph Hospital of Orange
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376661
- Sponsor's protocol ID
- 09-009 Active Surveillance
- Status last verified
- Mar 2021
- First submitted
- 3 Jun 2011
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study
- ClinicalTrials.gov ID
- NCT01376661
- Acronym / sponsor ID
- 09-009 Active Surveillance
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Active Surveillance, Low risk prostate cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Early termination due to PI's decision to discontinue research activities.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- St. Joseph Hospital of OrangeUniversity, hospital or other
- Study start
- May 2009 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 1 Sep 2016 (actual)
- First posted
- 20 Jun 2011 (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 purpose of this research study is to monitor the feasibility and outcome of the Active Surveillance Program for men with low risk prostate cancer.
Detailed description
The purpose of this observational study is to prospectively monitor the outcome associated with men who meet the eligibility criteria for low risk prostate cancer and elected to participate in the active surveillance program at The Center for Cancer Prevention and Treatment at St. Joseph Hospital. We hope to demonstrate that men who are compliant with a closely monitored active surveillance program for low risk prostate cancer will achieve favorable outcomes by: 1) avoiding the side effects of definitive therapy that may not be necessary; 2) retaining quality of life (QOL) and normal activities; 3) avoiding unnecessary treatment; and 4) decreased health care costs. In addition, we will monitor the possible adverse outcomes that may be associated with the active surveillance program including suboptimal response and/or greater side effects due to delayed initiation of therapy; psychological impact on the patients and caregivers due to anxiety of living with an untreated cancer and/or the requirement for frequent medical examination and periodic prostate biopsies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Surveillance/ Prostate Cancer | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with low risk prostate cancer.
Key inclusion criteria (12 listed)
- At least 18 years of age
- Histological documented adenocarcinoma of the prostate either newly diagnosed or previously diagnosed. Subjects who are diagnosed more than 3 months prior to time of enrollment in the active surveillance program must have biopsy repeated.
- PSA < 10 ng/ml within 1 month of program enrollment
- Clinical stage less than or equal to T2a
- Biopsy sampling with at least 10-12 cores
Key exclusion criteria (1 listed)
- See inclusion criteria for eligibility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of enrolled subjects who remain compliant free until disease progression.
Time frame: 10 years
This measurement will monitor the feasibility of the Active Surveillance Program for men with low risk prostate cancer
4 secondary outcomes
Percentage of enrolled subjects who require definitive therapy
Time frame: 10 years
Quality of Life as measured by patient survey.
Time frame: 10 Years
Overall survival
Time frame: 10 years
Cost/Benefit Analysis
Time frame: 10 Years
Results and safety
The study was stopped early (reason given: Early termination due to PI's decision to discontinue research activities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
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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.
Matthew Greenberger, MD principal investigator
St. Joseph Hospital of Orange
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 St. Joseph Hospital of Orange 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 12 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: stopped early, as of the sponsor's last update on 2 Apr 2021. 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 was stopped early (reason given: Early termination due to PI's decision to discontinue research activities.). Results are not available in the source record.
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?
Percentage of enrolled subjects who remain compliant free until disease progression. (time frame: 10 years). 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 2 Apr 2021.