SPCG-17 - when to treat men who are in active surveillance for prostate cancer, a randomized study comparing current practice with standardized triggers for initiation of curative treatment

Not Applicable

• Conditions: Active surveillance for low-risk and favourable intermediate-risk prostate cancer; Cancer; Low- and favourable intermediate-risk prostate cancer

• Registration Number: ISRCTN64382660
• Lead Sponsor: ppsala University

Brief Summary

2019 Protocol article in http://dx.doi.org/10.1136/bmjopen-2018-027860 protocol (added 21/09/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-20
• Last Update Posted: 29 January 2024
• Study Completion: 2034-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 2000

Inclusion Criteria

The inclusion criteria are:
1. Recently (within 12 months) diagnosed adenocarcinoma of the prostate
2. Tumour stage = T2a, NX, M0 (former MX)
3. PSA <15 ng/ml, PSA density = 0,2 ng/ml/cc
4. Gleason pattern 3+3=6 (any number of cores, any cancer involvement) or Gleason pattern 3+4=7 (<3 cores (or <30 % of cores if more than ten cores are taken), <10 mm cancer in one core)
5. Life expectancy >10 years with no upper age limit
6. Candidate for curative treatment if progression occurs
7. Signed written informed consent

Exclusion Criteria

Participants not fulfilling the inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified