The primary objectives of this study are to evaluate the safety and effectiveness of a novel diagnostic approach applying PSA-density and MRI-imaging-based monitoring, as opposed to immediate prostate biopsy, in men with an intermediate risk of…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety endpoint (non-inferiority): Detection percentage of ISUP GG >=2 PCa
during 48 months of follow up compared with the percentage of total ISUP GG >=2
PCa detected during the study, including findings from end-of-study biopsies.
Effectiveness endpoints: Detection of ISUP GG =1 and negative biopsy rates
during 48 months of follow up compared to total ISUP GG =1 and negative biopsy
rates including those obtained from end-of-study biopsy; prostate biopsy rates
during the study compared to total number of prostate biopsies including
end-of-study biopsies.
Secondary outcome
Cost-effectiveness: MRI-, complication-, outpatient consultation- and treatment
rates.
Health-related quality of life evaluated by questionnaires (EPIC-26 en 6-item
short STAI).
Upgrading and downgrading rates of MRI lesions.
Background summary
Suspicion for prostate cancer (PCa) based on elevated PSA level is a common
reason for urologic referrals. State-of-the-art diagnostic algorithms apply
risk calculator and/or MRI to indicate prostate biopsy. However, overdiagnosis
remains a significant shortcoming of the current pathway, especially in men
with an intermediate risk of harboring significant PCa (PIRADS 3 and PIRADS 4
with PSA density < 0.15) In these groups, a prostate biopsy results in a
negative result or insignificant prostate cancer (ISUP GG 1) in about 70% of
cases.
Study objective
The primary objectives of this study are to evaluate the safety and
effectiveness of a novel diagnostic approach applying PSA-density and
MRI-imaging-based monitoring, as opposed to immediate prostate biopsy, in men
with an intermediate risk of harbouring clinical significant PCa, with timely
detection of previously undetected tumours. This approach aims to preserve the
detection of ISUP GG >=2 PCa, while reducing overdiagnosis of ISUP GG = 1 PCa,
and avoiding unnecessary biopsies.
Study design
prospective Dutch multicenter study
Intervention
Biannual PSA test and annual MRI prostate. After 48 months end-of-study
biopsies in case there is still a visible lesion on MRI.
Study burden and risks
Every six months PSA measurements will be performed and with annual prostate
MRI. This is similar to follow-up in regular care for many men who would
receive direct biopsy according to standard of care (follow-up after negative
biopsy, or follow-up during active surveillance for low risk PCa). Two large
RCTs (PIVOT/PROTECT) showed that monitoring of men diagnosed with (cs)PCa was
not related to a higher (PCa-related) mortality, thus a negative impact on
oncological outcomes is highly unlikely. An end-of-study biopsy is conducted in
all men who were not subjected to one during the study with still a visible
lesion (PIRADS >= 3), to identify any (potential) cases of PCa that may have
been missed, to validate the follow-up protocol.
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Listed location countries
Age
Inclusion criteria
- Men aged > 18 years old
- Life expectancy > 10 years
- iPSA < 20 ng/ml
- no signs of extracapsular disease by digital rectal examination
- Mentally competent and understanding of benefits and potential burden of the
study.
- Written and signed informed consent.
- Intermediate-risk category for suspicion of prostate cancer determined by
bpMRI results and PSA density (PSAd): PIRADS 3 or PIRADS 4 with PSAd <=0.15.
- Willing to undergo follow-up protocol (PSA every 6 months, MRI every 12
months, for four years; end of study biopsy in case of PIRADS >= 3 lesion)
Exclusion criteria
- Men who have previously undergone a prostate biopsy
- Men who have a prior PCa diagnosis
- Not fulfilling inclusion criteria
- Using any (anti-)hormonal therapy, including 5-alpha reductase inhibitors
- Identified germline mutation associated with an increased risk of prostate
cancer (e.g., in BRCA1 or BRCA2 genes
- Secondary malignancy, besides basal cell carcinoma of the skin, for which the
patient is receiving active treatment at the time of inclusion
- Severe claustrophobia or other conditions that make MRI unsuitable (e.g.,
metal implants, pacemakers, or other metal-containing devices in the body)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87954.100.24 |