NCT02914873

Brief 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.

Trial Health

82
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,008

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
104mo left

Started Oct 2016

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
5 countries

23 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Oct 2016Dec 2034

First Submitted

Initial submission to the registry

September 20, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

October 3, 2016

Completed
18.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2034

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

18.2 years

First QC Date

September 20, 2016

Last Update Submit

January 15, 2026

Conditions

Prostate Cancer

Keywords

prostate canceractive surveillancestandardised treatment triggersMRIrandomized

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    Disease progression is defined as 1) cumulative incidence of PSA relapse after curative treatment or 2) cumulative incidence of androgen deprivation therapy in untreated men still in active surveillance.

    Median 10 years follow-up

Secondary Outcomes (6)

  • Cumulative incidence of pT3

    Median 10 years follow-up

  • Cumulative incidence of metastases

    Median 10 years follow-up

  • Cumulative number of treatments with curative intent (mainly radical prostatectomies or local radiotherapy)

    Median 10 years follow-up

  • Cumulative incidence of switch to watchful waiting

    Median 10 years follow-up

  • Prostate cancer mortality

    Median 10 years follow-up

  • +1 more secondary outcomes

Study Arms (2)

Current clinical practice for active surveillance

ACTIVE COMPARATOR

In this arm, patients are monitored according to current clinical practice for active surveillance at the trial centre. Repeat biopsies (and/or other examinations) and curative treatment are performed according to the urologist's judgement.

Procedure: Active surveillance

Standardized triggers for initiation of treatment with curative intent

EXPERIMENTAL

In this arm, patients are monitored according to a standardized active surveillance protocol with specific triggers for treatment. Repeat biopsies and curative treatment are only initiated if/when specific criteria are fulfilled.

Procedure: Active surveillance

Interventions

Active surveillancePROCEDURE

Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression.

Current clinical practice for active surveillanceStandardized triggers for initiation of treatment with curative intent

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Recently (within 12 months) diagnosed adenocarcinoma of the prostate
  • Tumor stage less than or equal to T2a, NX, M0
  • PSA less than 15 ng/ml, PSA density less than or equal to 0.20 ng/ml/cc
  • Gleason pattern 3+3=6 (any number of cores, any cancer involvement)
  • Gleason pattern 3+4=7 (less than 3 cores (or less than 30% of cores if more than 10 cores are taken), less than 10 mm cancer in one core)
  • Life expectancy more than 10 years with no upper age limit
  • Candidate for curative treatment if progression occurs
  • Signed written informed consent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Rigshospitalet

Copenhagen, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Helsinki University Hospital

Helsinki, Finland

Location

Seinäjoki Central Hospital

Tampere, Finland

Location

Ålesund Regional Hospital

Ålesund, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

University Hospital of North Norway

Tromsø, Norway

Location

St Olavs University Hospital

Trondheim, Norway

Location

Hospital of Vestfold

Tønsberg, Norway

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Linköping University Hospital

Linköping, Sweden

Location

Sunderby Regional Hospital

Luleå, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Sundsvall Regional Hospital

Sundsvall, Sweden

Location

Umeå University Hospital

Umeå, Sweden

Location

Akademiska University Hospital

Uppsala, Sweden

Location

Växjö Hospital

Vaxjo, Sweden

Location

Bedford Hospital

Bedford, United Kingdom

Location

Croydon University Hospital

Croydon, United Kingdom

Location

Epsom and St Helier Hospital

London, United Kingdom

Location

Guy's Hospital

London, United Kingdom

Location

Queen Elisabeth Hospital

London, United Kingdom

Location

Royal Marsden Hospital

London, United Kingdom

Location

Related Publications (1)

  • Ahlberg MS, Adami HO, Beckmann K, Bertilsson H, Bratt O, Cahill D, Egevad L, Garmo H, Holmberg L, Johansson E, Rannikko A, Van Hemelrijck M, Jaderling F, Wassberg C, Aberg UWN, Bill-Axelson A. PCASTt/SPCG-17-a randomised trial of active surveillance in prostate cancer: rationale and design. BMJ Open. 2019 Aug 22;9(8):e027860. doi: 10.1136/bmjopen-2018-027860.

    PMID: 31444180DERIVED

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Anna Bill-Axelson, MD, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 20, 2016

First Posted

September 26, 2016

Study Start

October 3, 2016

Primary Completion (Estimated)

December 1, 2034

Study Completion (Estimated)

December 1, 2034

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FI(2)NO(5)GB(6)DK(2)SE(8)