SPCG17: Prostate Cancer Active Surveillance Trigger Trial
NCT ID: NCT02914873
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
2000 participants
INTERVENTIONAL
2016-10-03
2034-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Active surveillance
Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression.
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.
Active surveillance
Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression.
Interventions
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Active surveillance
Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression.
Eligibility Criteria
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Inclusion Criteria
* 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
MALE
No
Sponsors
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Uppsala University
OTHER
Responsible Party
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Anna Bill-Axelson
Professor
Principal Investigators
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Anna Bill-Axelson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University
Locations
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Rigshospitalet
Copenhagen, , Denmark
Odense University Hospital
Odense, , Denmark
Helsinki University Hospital
Helsinki, , Finland
Seinäjoki Central Hospital
Tampere, , Finland
Ålesund Regional Hospital
Ålesund, , Norway
Oslo University Hospital
Oslo, , Norway
University Hospital of North Norway
Tromsø, , Norway
St Olavs University Hospital
Trondheim, , Norway
Hospital of Vestfold
Tønsberg, , Norway
Sahlgrenska University Hospital
Gothenburg, , Sweden
Linköping University Hospital
Linköping, , Sweden
Sunderby Regional Hospital
Luleå, , Sweden
Örebro University Hospital
Örebro, , Sweden
Sundsvall Regional Hospital
Sundsvall, , Sweden
Umeå University Hospital
Umeå, , Sweden
Akademiska University Hospital
Uppsala, , Sweden
Växjö Hospital
Vaxjo, , Sweden
Bedford Hospital
Bedford, , United Kingdom
Croydon University Hospital
Croydon, , United Kingdom
Epsom and St Helier Hospital
London, , United Kingdom
Guy's Hospital
London, , United Kingdom
Queen Elisabeth Hospital
London, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
Countries
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References
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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.
Related Links
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PCASTt/SPCG-17-a randomised trial of active surveillance in prostate cancer: rationale and design
Other Identifiers
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SPCG-17
Identifier Type: -
Identifier Source: org_study_id