Prostate CancerPCASTTNCT02914873
SPCG17: Prostate Cancer Active Surveillance Trigger Trial
A study testing Active surveillance in people with Prostate Cancer, run by Uppsala University at 23 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Active surveillance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,008 participants
- Where
- 23 sitesin 5 countries
- Study dates
- 3 Oct 2016to Dec 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- none
Trial locations and contacts
23 sites in 5 countries.
23 sites in 5 countries
Sweden8 sites
Sahlgrenska University Hospital
Gothenburg
Linköping University Hospital
Linköping
Sunderby Regional Hospital
Luleå
Örebro University Hospital
Örebro
Sundsvall Regional Hospital
Sundsvall
Umeå University Hospital
Umeå
Akademiska University Hospital
Uppsala
Växjö Hospital
Vaxjo
United Kingdom6 sites
Bedford Hospital
Bedford
Croydon University Hospital
Croydon
Epsom and St Helier Hospital
London
Guy's Hospital
London
Queen Elisabeth Hospital
London
Royal Marsden Hospital
London
Norway5 sites
Ålesund Regional Hospital
Ålesund
Oslo University Hospital
Oslo
Hospital of Vestfold
Tønsberg
University Hospital of North Norway
Tromsø
St Olavs University Hospital
Trondheim
Finland2 sites
Helsinki University Hospital
Helsinki
Seinäjoki Central Hospital
Tampere
About this study
Official title: 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.
Read the 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:
- A systematic repeat biopsy if PSA density increases to > 0.2 ng/ml/cc, and then at every 0.1 ng/ml/cc increase
- 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
- 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:
- 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
- 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.
- Conditions
- Prostate Cancer
- Being tested
- Active surveillance
- Keywords
- prostate cancer, active surveillance, standardised treatment triggers, MRI, randomized
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active surveillanceProcedure or surgery
Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Active surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Median 10 years follow-up
Secondary outcomes (6)
Cumulative incidence of pT3
Occurrence of confirmed pT3 in radical prostatectomy specimens according to the pathology report
Measured: Median 10 years follow-up
Cumulative incidence of metastases
Occurrence of distant metastasis (suspected or confirmed) during follow-up
Measured: 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)
Measured: Median 10 years follow-up
Cumulative incidence of switch to watchful waiting
Occurrence of conversions from active surveillance to watchful waiting during follow-up
Measured: 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.
Measured: Median 10 years follow-up
Quality of life of study participants
Assessed by questionnaire every second year
Measured: Median 10 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start3 Oct 2016
- Primary completionDec 2034 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Bill-Axelson, Uppsala University
- Investigators
- Anna Bill-Axelson, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914873
- Sponsor's protocol ID
- SPCG-17
- Acronym
- PCASTT
- Status last verified
- Jan 2026
- First submitted
- 20 Sep 2016
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31444180
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPCG17: Prostate Cancer Active Surveillance Trigger Trial (PCASTT)
- ClinicalTrials.gov ID
- NCT02914873
- Acronym / sponsor ID
- PCASTT / SPCG-17
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, active surveillance, standardised treatment triggers, MRI, randomized
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,008 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- Dec 2034 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- A systematic repeat biopsy if PSA density increases to > 0.2 ng/ml/cc, and then at every 0.1 ng/ml/cc increase
- 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
- 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:
- 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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current clinical practice for active surveillance | Active comparator | Procedure: Active surveillanceIn 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. |
| Standardized triggers for initiation of treatment with curative intent | Experimental | Procedure: Active surveillanceIn 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. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active surveillanceActive monitoring of prostate cancer and curative treatment if there are signs of tumor progression. | Procedure or surgery | Current clinical practice for active surveillance, Standardized triggers for initiation of treatment with curative intent |
Primary outcome
Progression-free survival
Time frame: Median 10 years follow-up
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.
6 secondary outcomes
Cumulative incidence of pT3
Time frame: Median 10 years follow-up
Cumulative incidence of metastases
Time frame: Median 10 years follow-up
Cumulative number of treatments with curative intent (mainly radical prostatectomies or local radiotherapy)
Time frame: Median 10 years follow-up
Cumulative incidence of switch to watchful waiting
Time frame: Median 10 years follow-up
Prostate cancer mortality
Time frame: Median 10 years follow-up
Quality of life of study participants
Time frame: Median 10 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Derived from this study: PubMed 31444180Ahlberg 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.
- PCASTt/SPCG-17-a randomised trial of active surveillance in prostate cancer: rationale and designLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Bill-Axelson, MD, PhD principal investigator
Uppsala University
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active surveillance in people with Prostate Cancer, run by Uppsala University at 23 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Sweden, United Kingdom, Norway, Denmark, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Median 10 years follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02914873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.