Outcome Assessment of an Active Surveillance Program for Low Risk Prostate Cancer: An Observational Study

Stopped early

Conditions studied: Prostate Cancer

In brief

The purpose of this research study is to monitor the feasibility and outcome of the Active Surveillance Program for men with low risk prostate cancer.

Key facts

Study ID

NCT01376661

Run by

St. Joseph Hospital of Orange

People needed

8

Starts

2009-05-01

Expected to finish

2016-09-01

Last updated by the study team

2021-04-02

Who can join

Age: 18 and older, up to 90. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age
• Histological documented adenocarcinoma of the prostate either newly diagnosed or previously diagnosed. Subjects who are diagnosed more than 3 months prior to time of enrollment in the active surveillance program must have biopsy repeated.
• PSA < 10 ng/ml within 1 month of program enrollment
• Clinical stage less than or equal to T2a
• Biopsy sampling with at least 10-12 cores
• Gleason score less than or equal to 3 + 3
• No more than 2 cores involved
• No core more than 50% involved
• Eligible for definitive therapy
• Able to provide informed consent
• Able to complete a QOL questionnaire
• Able to comply with the scheduled follow-up appointments

You may not qualify if…

• See inclusion criteria for eligibility

Where it is running

• St. Joseph Hospital of Orange — Orange, California, United States

Full record on ClinicalTrials.gov

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