Prostate CancerNCT00490763
Active Surveillance in Prostate Cancer
An observational study of Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to find out if men who have a type of prostate cancer that has been classified as "low risk" can safely not be treated for the disease. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,139 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2006to 6 Sep 2021
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study participants with low-risk prostate cancer who choose to undergo active surveillance.
Who may be able to join
- Patients will have histologic proof of adenocarcinoma of the prostate within six months of study entry.
- Patients must agree to have repeat extended 11-core multisite biopsy (sextant locations, midline, and 2 cores each from the left and right anterior horn) of the prostate at study entry. A baseline prostate biopsy is not indicated if a repeat biopsy following the extended biopsy scheme (at least 10 biopsy cores) was performed at The University of Texas M. D. Anderson Cancer Center (MDACC) within 6 months of study entry.
- Patients who have clinically localized cancer defined by pathologic and PSA criteria to be very low-risk/low-risk, patients with clinically localized cancer [not low-risk] who have refused early intervention or chosen active surveillance as a management option, and patients with clinically localized cancer who are precluded from local therapy because of comorbidities.
- Patients must agree to comply with the surveillance schedule.
- Non-English speaking patients may participate in the study, but they will not be required to complete the surveys.
- Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.
Who cannot join
- Active noncutaneous malignancy at any site.
- Prior radiation therapy for treatment of the primary tumor.
- Planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy while on protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Active Surveillance in Prostate Cancer: A Prospective Cohort Study
The goal of this clinical research study is to find out if men who have a type of prostate cancer that has been classified as "low risk" can safely not be treated for the disease. Doctors want to know if patients with "low risk" cancer can avoid or postpone therapy and the related side effects and still live as long as patients who immediately receive therapy.
This is an investigational study. There are no medications used in this trial.
About 1,000 patients will take part in this study. All will be enrolled at MD Anderson.
Read the detailed description
You have an early stage of prostate cancer that can be treated effectively with surgery or radiation. If you choose to take part in this study, you will be agreeing to receive only active surveillance. Active surveillance is an investigational way to manage low-stage small volume prostate cancer. While on active surveillance, you will have no treatment for the prostate cancer. However, you will have repeated Prostate Specific Antigen (PSA) tests, physical exams, and other testing to detect when the cancer is becoming a greater risk which may require you to begin treatment.
If you agree to participate in this study, you will not have standard therapy for prostate cancer. Your diagnosis will be confirmed as being of low risk by tests at MD Anderson. Blood will be drawn for PSA tests at the beginning of the study and every 6 months to monitor your cancer.
You will have a biopsy of the prostate at the beginning of the study. Additional prostate biopsies will be performed at your first repeat biopsy at Year 1, and when a doctor thinks it is necessary.
You will have digital rectal examination every 6 months to see if your doctor can feel any prostate nodules. You will have a transrectal ultrasonography every 12 months to see if your doctor can detect any abnormalities in the prostate.
Additionally, you will fill out 7 surveys at the beginning of the study and again every 6 months about how you are coping with the disease and the quality of your life. Each survey will take 5 to 10 minutes to complete.
While you are on study, if an exam or test results show that your disease is getting worse, you will be given the opportunity to have treatment to remove the cancer. If you do choose to receive treatment, you will be taken off study and continue to receive standard follow-up.
Long-Term Follow-Up:
Every 12 months, the study staff will review your medical record or you will be called or e-mailed and asked how you are doing. If you are called, the call would only last a few minutes.
This is an investigational study. About 1,000 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Prostate Cancer
- Being tested
- Survey
- Keywords
- Prostate Cancer, Active Surveillance, Prostate Specific Antigen, Questionnaire, Survey
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
Also called Questionnaire
7 surveys at the beginning of the study and again every 6 months about diet, coping with the disease, and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Active Surveillance | Patients with low-risk prostate cancer who choose to undergo active surveillance. Receives: Behavioral: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease Progression of Asymptomatic Patients with Clinically Localized Prostate Cancer
Primary end point of the study is time to disease progression, where progression is defined by pathologic criteria and/or an increase in tPSA value.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2007 (estimated)
- Study start13 Feb 2006
- Primary completion6 Sep 2021
- Study completion6 Sep 2021
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 M.D. Anderson Cancer 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,139 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Christopher Logothetis, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00490763
- Sponsor's protocol ID
- 2005-0619
- Other IDs
- R21CA223527-01
- Status last verified
- Apr 2022
- First submitted
- 21 Jun 2007
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Surveillance in Prostate Cancer: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT00490763
- Acronym / sponsor ID
- 2005-0619
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Active Surveillance, Prostate Specific Antigen, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,139 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Feb 2006 (actual)
- Primary completion
- 6 Sep 2021 (actual)
- Study completion
- 6 Sep 2021 (actual)
- First posted
- 25 Jun 2007 (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 clinical research study is to find out if men who have a type of prostate cancer that has been classified as "low risk" can safely not be treated for the disease. Doctors want to know if patients with "low risk" cancer can avoid or postpone therapy and the related side effects and still live as long as patients who immediately receive therapy.
This is an investigational study. There are no medications used in this trial.
About 1,000 patients will take part in this study. All will be enrolled at MD Anderson.
Detailed description
You have an early stage of prostate cancer that can be treated effectively with surgery or radiation. If you choose to take part in this study, you will be agreeing to receive only active surveillance. Active surveillance is an investigational way to manage low-stage small volume prostate cancer. While on active surveillance, you will have no treatment for the prostate cancer. However, you will have repeated Prostate Specific Antigen (PSA) tests, physical exams, and other testing to detect when the cancer is becoming a greater risk which may require you to begin treatment.
If you agree to participate in this study, you will not have standard therapy for prostate cancer. Your diagnosis will be confirmed as being of low risk by tests at MD Anderson. Blood will be drawn for PSA tests at the beginning of the study and every 6 months to monitor your cancer.
You will have a biopsy of the prostate at the beginning of the study. Additional prostate biopsies will be performed at your first repeat biopsy at Year 1, and when a doctor thinks it is necessary.
You will have digital rectal examination every 6 months to see if your doctor can feel any prostate nodules. You will have a transrectal ultrasonography every 12 months to see if your doctor can detect any abnormalities in the prostate.
Additionally, you will fill out 7 surveys at the beginning of the study and again every 6 months about how you are coping with the disease and the quality of your life. Each survey will take 5 to 10 minutes to complete.
While you are on study, if an exam or test results show that your disease is getting worse, you will be given the opportunity to have treatment to remove the cancer. If you do choose to receive treatment, you will be taken off study and continue to receive standard follow-up.
Long-Term Follow-Up:
Every 12 months, the study staff will review your medical record or you will be called or e-mailed and asked how you are doing. If you are called, the call would only last a few minutes.
This is an investigational study. About 1,000 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Surveillance | – | Behavioral: SurveyPatients with low-risk prostate cancer who choose to undergo active surveillance. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants with low-risk prostate cancer who choose to undergo active surveillance.
Key inclusion criteria (6 listed)
- Patients will have histologic proof of adenocarcinoma of the prostate within six months of study entry.
- Patients must agree to have repeat extended 11-core multisite biopsy (sextant locations, midline, and 2 cores each from the left and right anterior horn) of the prostate at study entry. A baseline prostate biopsy is not indicated if a repeat biopsy following the extended biopsy scheme (at least 10 biopsy cores) was performed at The University of Texas M. D. Anderson Cancer Center (MDACC) within 6 months of study entry.
- Patients who have clinically localized cancer defined by pathologic and PSA criteria to be very low-risk/low-risk, patients with clinically localized cancer [not low-risk] who have refused early intervention or chosen active surveillance as a management option, and patients with clinically localized cancer who are precluded from local therapy because of comorbidities.
- Patients must agree to comply with the surveillance schedule.
- Non-English speaking patients may participate in the study, but they will not be required to complete the surveys.
Key exclusion criteria (3 listed)
- Active noncutaneous malignancy at any site.
- Prior radiation therapy for treatment of the primary tumor.
- Planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy while on protocol.
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 |
|---|---|---|
| SurveyAlso: Questionnaire7 surveys at the beginning of the study and again every 6 months about diet, coping with the disease, and quality of life. | Behavioural | Active Surveillance |
Primary outcome
Time to Disease Progression of Asymptomatic Patients with Clinically Localized Prostate Cancer
Time frame: 5 years
Primary end point of the study is time to disease progression, where progression is defined by pathologic criteria and/or an increase in tPSA value.
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 4 Apr 2022.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
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.
Christopher Logothetis, MD principal investigator
M.D. Anderson Cancer Center
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 M.D. Anderson Cancer 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 6 inclusion and 3 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 4 Apr 2022. 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?
Time to Disease Progression of Asymptomatic Patients with Clinically Localized Prostate Cancer (time frame: 5 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 4 Apr 2022.