Active Surveillance in Prostate Cancer

• ClinicalTrials.gov Identifier: NCT00490763
• Recruitment Status: Active, not recruiting
• First Posted: June 25, 2007
• Last Update Posted: July 23, 2019
• Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Tracking Information

• First Submitted Date: June 21, 2007
• First Posted Date: June 25, 2007
• Last Update Posted Date: July 23, 2019
• Actual Study Start Date: February 13, 2006
• Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 16, 2015)

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.

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Active Surveillance in Prostate Cancer
• Official Title: Active Surveillance in Prostate Cancer: A Prospective Cohort Study

Brief 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. 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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Study participants with low-risk prostate cancer who choose to undergo active surveillance.
• Condition: Prostate Cancer

Intervention

Behavioral: Survey

7 surveys at the beginning of the study and again every 6 months about diet, coping with the disease, and quality of life.

Other Name: Questionnaire

Study Groups/Cohorts

Active Surveillance

Patients with low-risk prostate cancer who choose to undergo active surveillance.

Intervention: Behavioral: Survey

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: September 14, 2016): 1139
• Original Estimated Enrollment (submitted: June 21, 2007): 650
• Estimated Study Completion Date: February 2021
• Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Patients will have histologic proof of adenocarcinoma of the prostate within six months of study entry.
2. 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.
3. 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.
4. Patients must agree to comply with the surveillance schedule.
5. Non-English speaking patients may participate in the study, but they will not be required to complete the surveys.
6. Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.

Exclusion Criteria:

1. Active noncutaneous malignancy at any site.
2. Prior radiation therapy for treatment of the primary tumor.
3. Planned concomitant immunotherapy, hormonal therapy, chemotherapy, or radiation therapy while on protocol.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00490763
• Other Study ID Numbers: 2005-0619; R21CA223527-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: M.D. Anderson Cancer Center
• Study Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)

Investigators

• Principal Investigator: Christopher Logothetis, MD; M.D. Anderson Cancer Center

• PRS Account: M.D. Anderson Cancer Center
• Verification Date: July 2019