Monitoring prostate cancer in men choosing active surveillance
Canary Prostate Active Surveillance Study
University of Washington · NCT00756665
This study is trying to find out if certain markers can help tell the difference between aggressive and less serious prostate cancers in men who are choosing to monitor their condition instead of starting treatment right away.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 21 Years and up |
| Sex | Male |
| Sponsor | University of Washington (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 11 sites (San Francisco, California and 10 other locations) |
| Trial ID | NCT00756665 on ClinicalTrials.gov |
What this trial studies
The Prostate Active Surveillance Study (PASS) focuses on men who have opted for active surveillance as a management strategy for their localized prostate cancer. This multi-center, prospective study aims to identify biomarkers that differentiate aggressive prostate cancers from those that are less likely to progress. Participants undergo regular monitoring through PSA tests, digital rectal examinations, and biopsies, with treatment initiated if there are signs of disease progression. The study also seeks to evaluate the clinical predictors of progression and the long-term survival outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are men with histologically confirmed localized prostate cancer who have chosen active surveillance as their management plan.
Not a fit: Patients with advanced prostate cancer or those who have previously received treatment for prostate cancer will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification of aggressive prostate cancers, allowing for more tailored treatment approaches.
How similar studies have performed: Other studies have shown promise in identifying biomarkers for prostate cancer progression, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate from a prostate biopsy. * Clinically localized prostate cancer: T1-2, NX or N0, MX or M0. * No previous treatment for prostate cancer (including hormonal therapy, radiation therapy, surgery, or chemotherapy). * ECOG Performance Status 0 or 1. * Patient has elected Active Surveillance as preferred management plan for prostate cancer. * Patient consent has been obtained according to local Institutional Review Board for acquisition of research specimens. * Patient is accessible and compliant for follow-up. * Prostate cancer diagnosis cannot be more than 3 years prior to baseline visit date. * No more than two prostate biopsies including the initial biopsy in which cancer was diagnosed. * If cancer diagnosis is more than one year before enrollment, there must be two prostate biopsies including the initial biopsy in which cancer was diagnosed and a subsequent biopsy. The subsequent biopsy may occur on the same day as the baseline visit. * Biopsies must have at least 10 cores. Exclusion Criteria: * Unwillingness or inability to undergo serial prostate biopsy. * History of other malignancies, except: adequately treated non-melanoma skin cancer or adequately treated superficial bladder cancer (Ta) or other solid tumors curatively treated with no evidence of disease for \> 5 years.
Where this trial is running
San Francisco, California and 10 other locations
- Veterans Affairs San Francisco Health Care System — San Francisco, California, United States (RECRUITING)
- University of California, San Francisco — San Francisco, California, United States (RECRUITING)
- Stanford University — Stanford, California, United States (RECRUITING)
- Emory University — Atlanta, Georgia, United States (RECRUITING)
- Beth Israel Deaconess Medical Center/Harvard Medical School — Boston, Massachusetts, United States (RECRUITING)
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
- University of Texas Health Science Center, San Antonio — San Antonio, Texas, United States (RECRUITING)
- Eastern Virginia Medical School — Norfolk, Virginia, United States (RECRUITING)
- Veterans Affairs Puget Sound Health Care System — Seattle, Washington, United States (RECRUITING)
- University of Washington — Seattle, Washington, United States (RECRUITING)
- University of British Columbia — Vancouver, British Columbia, Canada (RECRUITING)
Study contacts
- Principal investigator: Daniel W. Lin, MD — University of Washington
- Study coordinator: Lisa Newcomb, PhD
- Email: lnewcomb@fredhutch.org
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostatic Neoplasms, prostate, cancer