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Prostate Active Surveillance Study

Canary Prostate Active Surveillance Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Candidates are assessed based on an extended core biopsy, serum PSA (including PSA kinetics, if available), digital rectal examination (DRE), and assessment of cancer grade and extent."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks for signs that can tell fast-growing prostate cancers from slow-growing ones. It is for men who have chosen active surveillance: close checks of their prostate cancer, with treatment offered if test results change.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A prostate biopsy (small tissue samples) confirmed adenocarcinoma, a type of prostate cancer.
  • The cancer is limited to the prostate. Spread to lymph nodes or other body parts is either not found or not known.
  • You have had no prostate cancer treatment, including hormone treatment, radiation, surgery, or chemotherapy.
  • You can do all usual activities, or you have trouble only with hard physical activity and can still do light work.
  • You chose active surveillance, agreed to give research samples, and can attend and follow the plan for follow-up visits.
  • Your cancer was diagnosed no more than 3 years before your first study visit.
  • You have had no more than 2 prostate biopsies, including the one that found cancer. If diagnosed more than 1 year before joining, you must have a second biopsy, which may be done at your first study visit.
  • Each biopsy must include at least 10 tissue samples.

Who can't join

  • You cannot or do not want to have repeated prostate biopsies.
  • You have had another cancer. Exceptions are non-melanoma skin cancer or surface-only bladder cancer (Ta) that was properly treated, or another solid tumor treated to cure it with no signs of cancer for more than 5 years.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (10)

CA

GA

MA

MI

TX

VA

WA