No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
21 and older
Sex
Male
Study type
Observational
Participants needed
3,000 (estimated)
Sponsor
University of Washington · Other
Who this trial is looking for
This trial is looking for men who have chosen active surveillance for their prostate cancer. Participants will be monitored closely to identify more aggressive cancers versus those that grow slowly.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with prostate cancer.
I have not received any treatment for my prostate cancer.
I prefer active surveillance as my management plan.
I can provide consent for research.
I can attend follow-up appointments.
My prostate cancer was diagnosed within the last 3 years.
I have had no more than two prostate biopsies.
My biopsies have 10 or more samples.
You may not be able to join if
I cannot have repeated prostate biopsies.
I have a history of other cancers not treated adequately.
I have had prostate cancer treatment before.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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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 Perfo…
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.
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