SPCG17: Prostate Cancer Active Surveillance Trigger Trial
NCT02914873 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2008
Last updated 2026-01-20
Summary
A large proportion of men with prostate cancer are overdiagnosed and overtreated mainly due to PSA testing. Active surveillance (AS) aims to reduce these harms by recommending curative treatment only when and if signs of tumor progression occur. There are however a number of uncertainties in AS, the most important being when to initiate treatment. The investigators are therefore starting a large randomized multicenter trial testing the safety of a standardized active surveillance protocol with specified triggers for repeat biopsies and initiation of curative treatment. The standardized protocol is compared with current practice for active surveillance. The primary aim of the study is to reduce overtreatment and subsequent side effects, without increasing the risk of disease progression or prostate cancer mortality.
Conditions
Interventions
- PROCEDURE
-
Active surveillance
Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression.
Sponsors & Collaborators
-
Uppsala University
lead OTHER
Principal Investigators
-
Anna Bill-Axelson, MD, PhD · Uppsala University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-03
- Primary Completion
- 2034-12-31
- Completion
- 2034-12-31
Countries
- Denmark
- Finland
- Norway
- Sweden
- United Kingdom
Study Locations
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