Active Surveillance in Prostate Cancer

NCT00490763 | Completed

• 2 other identifiers: 2005-0619R21CA223527-01
• Study Type: observational
• Target: 1,139
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Active Surveillance; Prostate Specific Antigen; Questionnaire; Survey

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Study Arms (1)

Active Surveillance

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

Behavioral: Survey

Interventions

Survey BEHAVIORAL

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

Also known as: Questionnaire

Active Surveillance

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Christopher Logothetis, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2007
• First Posted: June 25, 2007
• Study Start: February 13, 2006
• Primary Completion: September 6, 2021
• Study Completion: September 6, 2021
• Last Updated: April 4, 2022

Record last verified: 2022-04

Locations

US (1)