SPCG-17

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.

Stopped inclusion/Active

SPCG-17 info

Read more on ClinicalTrials.gov

clinicaltrials.gov

Principal investigator

Anna Bill-Axelson, Department of Surgical Sciences, Urology, Uppsala University

Contact details

Patients

Men newly diagnosed with prostate cancer, ≤T2a, PSA <15 ng/mL, PSA density ≤0.2 ng/mL/cc, any ISUP grade 1, or ISUP grade 2 in <30% of cores on systematic biopsy and <10 mm cancer in one core on systematic or targeted biopsy.

Treatment

Active surveillance using standardized triggers for repeated biopsies and initiation of treatment with curative intent (experimental arm) is compared with current clinical practice for active surveillance (control arm).

Primary study objective

To evaluate whether standardized triggers for initiation of curative treatment reduces overtreatment without increasing disease progression and prostate cancer mortality among men with low- and favorable intermediate risk prostate cancer.

Primary_endpoint

Progression-free survival

Secondary endpoints

Cumulative incidence of metastatic disease, treatments with curative intent, pT3-4 at radical prostatectomy, switch to watchful waiting, prostate cancer mortality, and quality of life.

Inclusion period

Recruitment October 2016 - September 2024. Follow-up according to the protocol continues until initiation of treatment with curative intent, detection of metastasis, switch from active surveillance to watchful waiting, or death of any cause. Thereafter management according to standard clinical practice but with annual reporting in the study. Planned end of follow up in study 2040. First report in 2027.

Number of patients

2009

Monitoring

External monitors

Sponsor

Uppsala University

1 publications

Publications of the SPCG-17 trial

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

Mats Steinholtz Ahlberg, Hans-Olov Adami, Kerri Beckmann, Helena Bertilsson, Ola Bratt, Declan Cahill, Lars Egevad, Hans Garmo, Lars Holmberg, Eva Johansson, Antti Rannikko, Mieke Van Hemelrijck, Fredrik Jäderling, Cecilia Wassberg, Ulrika W N Åberg, Anna Bill-Axelson

BMJ Open

Abstract