Clinical trial · Observational
Active Surveillance in Prostate Cancer
Active Surveillance in Prostate Cancer: A Prospective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Survey | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Active Surveillance
- description
- Patients with low-risk prostate cancer who choose to undergo active surveillance.
- interventionNames
- Behavioral: Survey
Primary outcomes (1)
- measure
- Time to Disease Progression of Asymptomatic Patients with Clinically Localized Prostate Cancer
- timeFrame
- 5 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available