| NCT ID | NCT00756665 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Washington |
| Condition | Prostatic Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2008-07 |
| Primary Completion | 2029-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2008-07 with a primary completion date of 2029-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The Prostate Active Surveillance Study (PASS) is a research study for men who have chosen active surveillance as a management plan for their prostate cancer. Active surveillance is defined as close monitoring of prostate cancer with the offer of treatment if there are changes in test results. This study seeks to discover markers that will identify cancers that are more aggressive from those tumors that grow slowly.
Eligibility 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.
Contact & Investigator
Lisa Newcomb, PhD
✉ lnewcomb@fredhutch.orgDaniel W. Lin, MD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT00756665 clinical trial?
This trial is open to male participants only, aged 21 Years or older, studying Prostatic Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00756665 currently recruiting?
Yes, NCT00756665 is actively recruiting participants. Contact the research team at lnewcomb@fredhutch.org for enrollment information.
Where is the NCT00756665 trial being conducted?
This trial is being conducted at San Francisco, United States, San Francisco, United States, Stanford, United States, Atlanta, United States and 7 additional locations.
Who is sponsoring the NCT00756665 clinical trial?
NCT00756665 is sponsored by University of Washington. The principal investigator is Daniel W. Lin, MD at University of Washington. The trial plans to enroll 3,000 participants.