SPCG17: Prostate Cancer Active Surveillance Trigger Trial (PCASTT)

SPCG17: Prostate Cancer Active Surveillance Trigger Trial (PCASTT)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Active surveillance

Detailed Description

STUDY HYPOTHESIS

The study hypothesis is that standardized triggers for initiation of curative treatment of men who are in active surveillance will reduce overtreatment without increasing disease progression and prostate cancer mortality.

STUDY DESIGN

Randomized multi-centre open-label clinical trial

INTERVENTIONS

Computerized randomisation (1:1) within 12 months from diagnosis of prostate cancer, either to active surveillance according to current clinical practice at the trial centre (reference arm), or to a standardised active surveillance protocol applying specific criteria for repeat biopsies and the initiation of curative treatment (experimental arm). Patients are stratified by centre and Gleason score.

Follow-up both groups: PSA every 6 months, clinical examination (with PSA test) annually, and MRI every second year.

Repeat biopsies (reference arm): Current practice

Repeat biopsies (experimental arm), standardised triggers:

1. A systematic repeat biopsy if PSA density increases to > 0.2 ng/ml/cc, and then at every 0.1 ng/ml/cc increase
2. MRI progression in men with previously only Gleason grade 3+3: 5 mm or more increase in size in any dimension of a measurable lesion, increase in PI-RADS score to 3-5, a new lesion with PI-RADS score 3-5, or high or very high suspicion of extra-capsular extension or seminal vesicle invasion
3. MRI progression in men with Gleason grade 3+4: 5 mm or more increase in size in any dimension of a measurable lesion, or a new lesion with PI-RADS score 3-5

Curative treatment (reference arm): Current practice

Curative treatment (experimental arm), standardised triggers:

1. MRI progression in lesions with confirmed Gleason grade 4: increase in PI-RADS score to 4 or 5, or high or very high suspicion of extra-capsular extension or seminal vesicle invasion
2. Pathological progression: Gleason pattern 5, primary Gleason pattern 4 in any core with 5 mm or more cancer, Gleason 3+4 in 3 or more cores or 30% if more than 10 cores are taken, or Gleason 3+4 in 10 mm or more cancer

Patients will be followed continuously until initiation of treatment, the event of metastasis, to a break point where active surveillance is considered terminated and watchful waiting starts, or to death of any cause. For men who discontinue active surveillance, the follow-up and management continue according to standard clinical practice but with annual reporting in the study.

• Study Type: Interventional
• Enrollment (Actual): 2008
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
  • Odense, Denmark
    • Odense University Hospital
• Finland
  • Helsinki, Finland
    • Helsinki University Hospital
  • Tampere, Finland
    • Seinäjoki Central Hospital
• Norway
  • Oslo, Norway
    • Oslo University Hospital
  • Tromsø, Norway
    • University Hospital of North Norway
  • Trondheim, Norway
    • St Olavs University Hospital
  • Tønsberg, Norway
    • Hospital of Vestfold
  • Ålesund, Norway
    • Ålesund Regional Hospital
• Sweden
  • Gothenburg, Sweden
    • Sahlgrenska University Hospital
  • Linköping, Sweden
    • Linkoping University Hospital
  • Luleå, Sweden
    • Sunderby Regional Hospital
  • Sundsvall, Sweden
    • Sundsvall Regional Hospital
  • Umeå, Sweden
    • Umea University Hospital
  • Uppsala, Sweden
    • Akademiska University hospital
  • Vaxjo, Sweden
    • Växjö Hospital
  • Örebro, Sweden
    • Orebro University Hospital
• United Kingdom
  • Bedford, United Kingdom
    • Bedford Hospital
  • Croydon, United Kingdom
    • Croydon University Hospital
  • London, United Kingdom
    • Royal Marsden Hospital
  • London, United Kingdom
    • Guy's Hospital
  • London, United Kingdom
    • Epsom and St Helier Hospital
  • London, United Kingdom
    • Queen Elisabeth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Current clinical practice for active surveillance; 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; Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression.
Experimental: Standardized triggers for initiation of treatment with curative intent; 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; Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of metastases	Occurrence of distant metastasis (suspected or confirmed) during follow-up	Median 10 years follow-up
Cumulative number of treatments with curative intent (mainly radical prostatectomies or local radiotherapy)	Occurrence of radical prostatectomies or local radiotherapy (with or without adjuvant androgen deprivation therapy)	Median 10 years follow-up
Cumulative incidence of switch to watchful waiting	Occurrence of conversions from active surveillance to watchful waiting during follow-up	Median 10 years follow-up
Cumulative incidence of pT3	Occurrence of confirmed pT3 in radical prostatectomy specimens according to the pathology report	Median 10 years follow-up
Prostate cancer mortality	Prostate cancer-specific mortality at 10 years of follow-up will be analysed, with competing causes of death taken into account.	Median 10 years follow-up
Quality of life of study participants	Assessed by questionnaire every second year	Median 10 years follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative prostate cancer mortality	Final endpoint at 10 years of follow-up is prostate cancer mortality, with competing causes of death taken into account	Final effect measure at 10 years of follow-up

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Principal Investigator: Anna Bill-Axelson, MD, PhD, Uppsala University

Publications and helpful links

General Publications

• 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.

Helpful Links

• PCASTt/SPCG-17-a randomised trial of active surveillance in prostate cancer: rationale and design

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2016
• Primary Completion (Estimated): December 1, 2034
• Study Completion (Estimated): December 1, 2034

Study Registration Dates

• First Submitted: September 20, 2016
• First Submitted That Met QC Criteria: September 23, 2016
• First Posted (Estimated): September 26, 2016

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: MRI; prostate cancer; active surveillance; randomized; standardised treatment triggers
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Watchful Waiting
• Other Study ID Numbers: SPCG-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No