Seoul National University Prospectively Enrolled Registry for Prostate Cancer With Active Surveillance

Recruiting now

Conditions studied: Prostate Cancer

In brief

In this study, the investigators aim to establish the prostate cancer active surveillance prospective cohort in our institution, and finally investigate the 5 year rates of reclassification during active surveillance as the primary endpoint of the current study.

Key facts

Study ID

NCT02971085

Run by

Seoul National University Hospital

People needed

410

Starts

2016-12-01

Expected to finish

2027-01-01

Last updated by the study team

2019-02-12

Who can join

Age: 40 and older, up to 80. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men < 80 years
• Pathologically proven adenocarcinoma of the prostate by transrectal prostate biopsy ≥ 10 cores
• Pre-Bx PSA ≤ 10ng/ml
• PSA density < 0.15ng/ml/ml
• Clinical stage T1-2a
• Biopsy Gleason score ≤ 6
• No. of positive cores ≤ 2
• Maximum cancer involvement in any one core ≤ 20%.
• No PIRADS 5 lesion on multiparametric prostate MRI (1.5T or 3T)
• Participants must be willing to attend the follow-up visits - T1a-b disease should be confirmed by systematic TRUS-Bx ≥ 10 cores

You may not qualify if…

• A former therapy for prostate cancer.

Where it is running

• Seoul National University Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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