Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT02914873 |
| Other study ID # |
SPCG-17 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2016 |
| Est. completion date |
December 2034 |
Study information
| Verified date |
May 2024 |
| Source |
Uppsala University |
| Contact |
Anna Bill-Axelson, MD, PhD |
| Phone |
+46 701679747 |
| Email |
anna.bill.axelson[@]uu.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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 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. After the initiation of curative treatment,
watchful waiting, or palliative treatment for cancer progression, the patient is followed
according to the standard protocol of the participating centre.
