Clinical trial · Interventional
SPCG17: Prostate Cancer Active Surveillance Trigger Trial
SPCG17: Prostate Cancer Active Surveillance Trigger Trial (PCASTT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active surveillance | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Current clinical practice for active surveillance
- description
- 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.
- interventionNames
- Procedure: Active surveillance
- type
- EXPERIMENTAL
- label
- Standardized triggers for initiation of treatment with curative intent
- description
- 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.
- interventionNames
- Procedure: Active surveillance
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAhlberg 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 31444180