Prostate Active Surveillance Study

Launched by UNIVERSITY OF WASHINGTON · Sep 18, 2008

Keywords

ClinConnect Summary

The Prostate Active Surveillance Study (PASS) is a research study designed for men who have decided to closely monitor their prostate cancer rather than start treatment right away. This approach, known as active surveillance, involves regular check-ups and tests to keep an eye on the cancer, with treatment offered if there are any changes that suggest the cancer is becoming more aggressive. The goal of this study is to find specific markers that can help doctors distinguish between aggressive forms of prostate cancer and those that grow slowly, allowing for better management of the disease.

To participate in this study, men must meet certain criteria. They should have a confirmed diagnosis of prostate cancer from a biopsy and have chosen active surveillance as their management plan. Participants should not have received any previous treatment for their cancer and must be able to undergo follow-up biopsies. If you or someone you know is interested in joining, it’s important to know that the study is currently recruiting participants aged 76 to 70, and they will be expected to attend follow-up appointments and undergo additional biopsies to help researchers gather essential information about the cancer. This study aims to improve how prostate cancer is monitored and treated in the future.

Gender

MALE

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.