SPCG17: Prostate Cancer Active Surveillance Trigger Trial

NCT02914873 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2008

Last updated 2026-01-20

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02914873 on ClinicalTrials.gov